| 10031101 |
Placebo |
2020-07-28 |
2020-07-28 |
2020-08-18 |
1 |
2020-09-09 |
poison ivy |
N |
2020-09-09 |
Poison Ivy on both legs, both arms, and both wrists. |
N |
TRUE |
FALSE |
TRUE |
| 10031111 |
Placebo |
2020-07-30 |
2020-07-30 |
2020-08-20 |
1 |
2020-09-26 |
Tenosynovitis |
N |
2020-09-26 |
psoriatic arthritis |
Y |
TRUE |
FALSE |
FALSE |
| 10051011 |
Placebo |
2020-08-10 |
2020-08-10 |
2020-08-31 |
2 |
2020-09-01 |
LEG PAIN |
N |
2020-09-01 |
BILATERAL LEG PAIN |
N |
TRUE |
FALSE |
TRUE |
| 10051082 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-19 |
2020-08-19 |
2020-09-09 |
1 |
2020-09-05 |
TEAR GAS EXPOSURE |
N |
2020-09-05 |
CLOUDING OF CONCIOUSNESS |
N |
TRUE |
FALSE |
TRUE |
| 10051150 |
Placebo |
2020-08-26 |
2020-08-26 |
2020-09-14 |
1 |
2020-09-15 |
LEFT UPPER ARM PAIN |
N |
2020-09-15 |
PINCHED NERVE IN NECK |
N |
TRUE |
FALSE |
TRUE |
| 10051183 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-31 |
2020-08-31 |
2020-09-23 |
1 |
2020-09-01 |
CONGESTION NFI |
N |
2020-09-01 |
NASAL CONGESTION |
N |
TRUE |
FALSE |
TRUE |
| 10051217 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-03 |
2020-09-03 |
2020-09-24 |
1 |
2020-09-04 |
CALOR |
N |
2020-09-04 |
overall body CALOR - no fever |
N |
TRUE |
FALSE |
TRUE |
| 10071148 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-06 |
2020-08-06 |
2020-08-27 |
1 |
2020-08-27 |
nodule at vaccination site |
N |
2020-08-27 |
nodule at injection site |
N |
TRUE |
FALSE |
TRUE |
| 10081211 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-08 |
2020-09-08 |
2020-09-29 |
1 |
2020-09-16 |
Shingles |
N |
2020-09-16 |
sciatica |
N |
TRUE |
FALSE |
TRUE |
| 10081605 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-14 |
2020-10-14 |
2020-11-03 |
1 |
2020-10-15 |
Chills |
N |
2020-10-15 |
Fatigue |
N |
TRUE |
FALSE |
TRUE |
| 10081605 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-14 |
2020-10-14 |
2020-11-03 |
2 |
2020-10-15 |
Fatigue |
N |
2020-10-15 |
Body aches |
N |
TRUE |
FALSE |
TRUE |
| 10081605 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-14 |
2020-10-14 |
2020-11-03 |
3 |
2020-10-15 |
Body aches |
N |
2020-10-15 |
Chills |
N |
TRUE |
FALSE |
TRUE |
| 10121120 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-02 |
2020-09-02 |
2020-09-23 |
3 |
2020-09-23 |
LOW GRADE FEVER |
N |
2020-09-23 |
FEVER |
N |
TRUE |
FALSE |
TRUE |
| 10151096 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-24 |
2020-08-24 |
2020-09-14 |
1 |
2020-09-14 |
Whole arm pain throughout - arm where IP vaccine was received |
N |
2020-09-14 |
Whole left arm pain |
N |
TRUE |
FALSE |
TRUE |
| 10151224 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-23 |
2020-09-23 |
2020-10-14 |
1 |
2020-09-23 |
Sore arm - whole arm where IP vaccine was received |
N |
2020-09-23 |
Injection site pain |
N |
TRUE |
FALSE |
TRUE |
| 10151241 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-07 |
2020-10-07 |
2020-10-28 |
1 |
2020-10-07 |
Sore arm - Whole arm where IP vaccine was received |
N |
2020-10-07 |
Injection site pain |
N |
TRUE |
FALSE |
TRUE |
| 10161282 |
Placebo |
2020-09-11 |
2020-09-11 |
2021-01-04 |
1 |
2020-09-26 |
Gout Right Foot, First Digit |
N |
2020-09-26 |
Worsening of Gout Right Foot, First Digit |
N |
TRUE |
FALSE |
TRUE |
| 10191146 |
Placebo |
2020-09-01 |
2020-09-01 |
2020-09-22 |
1 |
2020-10-27 |
poorly differentiated carcinoma metastatic to liver |
Y |
2020-10-27 |
Biliary Cancer Metastatic |
Y |
TRUE |
FALSE |
TRUE |
| 10191254 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-05 |
2020-10-05 |
2020-11-17 |
2 |
2020-10-24 |
Pancreatic Mass |
Y |
2020-10-15 |
Urinary Tract Infection |
Y |
FALSE |
FALSE |
TRUE |
| 10211024 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-12 |
2020-08-12 |
2020-09-08 |
1 |
2020-08-18 |
Rectal Bleeding |
N |
2020-08-18 |
Benign Colon Polyps |
N |
TRUE |
FALSE |
TRUE |
| 10211134 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-01 |
2020-09-01 |
2020-10-13 |
1 |
2020-09-02 |
Inflammation in right leg |
N |
2020-09-02 |
Swelling in right leg |
N |
TRUE |
FALSE |
TRUE |
| 10221155 |
Placebo |
2020-09-14 |
2020-09-14 |
2020-10-05 |
1 |
2020-10-11 |
Mild Headache |
N |
2020-10-11 |
Headache (worse than baseline) |
N |
TRUE |
FALSE |
TRUE |
| 10241002 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-12 |
2020-08-12 |
2020-09-01 |
|
2020-08-12; 2020-08-17; 2020-09-01 |
FATIGUE | Subject dosed with IP that had temperature excursion (product storage error) | Subject was dosed with IP that had temperature excursion (product storage error) |
|
2020-08-17; 2020-09-01 |
FATIGUE | Subject was dosed with IP that had temperature excursion (product storage error) |
|
FALSE |
FALSE |
TRUE |
| 10241009 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-13 |
2020-08-13 |
2020-09-03 |
|
2020-08-13; 2020-09-04 |
FATIGUE | HEADACHE | JOINT PAIN | MUSCLE PAIN | PAIN AT INJECTION SITE | Subject was dosed with IP that had temperature excursion (product storage error) |
|
2020-09-04 |
FATIGUE | HEADACHE | JOINT PAIN | MUSCLE PAIN | PAIN AT INJECTION SITE |
|
FALSE |
FALSE |
TRUE |
| 10241121 |
Placebo |
2020-10-08 |
2020-10-08 |
2020-10-28 |
|
2020-10-14 |
CHILLS | FATIGUE |
|
2020-10-14; 2020-10-28; 2020-11-03 |
CHILLS | DIARRHEA | FATIGUE | HEADACHE |
|
FALSE |
FALSE |
TRUE |
| 10271105 |
Placebo |
2020-08-28 |
2020-08-28 |
— |
1 |
2020-08-29 |
Allergic Reaction to Study Vaccine |
N |
2020-08-29 |
Allergic Reaction to investigational product |
N |
TRUE |
FALSE |
TRUE |
| 10281014 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-18 |
2020-08-18 |
2020-09-08 |
2 |
2020-09-08 |
sore arm right deltoid |
N |
2020-09-08 |
sore arm right deltoid injection site |
N |
TRUE |
FALSE |
TRUE |
| 10301030 |
Placebo |
2020-09-01 |
2020-09-01 |
2020-09-21 |
1 |
2020-09-05 |
urinary tract infections |
N |
2020-09-05 |
urinary tract infection |
N |
TRUE |
FALSE |
TRUE |
| 10371178 |
Placebo |
2020-09-09 |
2020-09-09 |
2020-10-01 |
1 |
2020-10-11 |
BRUISE RIGHT ARM |
N |
2020-11-04 |
LIPODYSTROPHY (Right arm) |
N |
FALSE |
FALSE |
TRUE |
| 10371183 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-10 |
2020-09-10 |
2020-10-01 |
1 |
2020-10-02 |
RIGHT ARM SORENESS |
N |
2020-10-02 |
RIGHT ARM SORENESS INJECTION SITE |
N |
TRUE |
FALSE |
TRUE |
| 10371334 |
Placebo |
2020-10-12 |
2020-10-12 |
2020-11-04 |
1 |
2020-11-02 |
TOOTH ACHE |
N |
2020-11-02 |
DENTAL CARIES |
N |
TRUE |
FALSE |
TRUE |
| 10381074 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-01 |
2020-09-01 |
2020-09-23 |
2 |
2020-09-23 |
fever (100F) |
N |
2020-09-23 |
Increased Body Temperature (100F) |
N |
TRUE |
FALSE |
TRUE |
| 10391153 |
Placebo |
2020-09-21 |
2020-09-21 |
2020-10-12 |
1 |
2020-09-22 |
Fever 99.4 |
N |
2020-09-22 |
Increased Body temperature |
N |
TRUE |
FALSE |
TRUE |
| 10441093 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-08 |
2020-09-08 |
2020-09-28 |
3 |
2020-10-23 |
Accidental Drug Overdose |
Y |
2020-10-23 |
Heroin Overdose |
Y |
TRUE |
FALSE |
TRUE |
| 10441157 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-01 |
2020-10-01 |
2020-10-20 |
2 |
2020-10-21 |
elevated temperature |
N |
2020-10-21 |
Fever |
N |
TRUE |
FALSE |
TRUE |
| 10471063 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-27 |
2020-08-27 |
2020-09-15 |
3 |
2020-09-16 |
Temp 100.8 |
N |
2020-09-16 |
Fever 100.8 |
N |
TRUE |
FALSE |
TRUE |
| 10471070 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-27 |
2020-08-27 |
2020-09-15 |
2 |
2020-09-16 |
Temperature Increase 102.2 |
N |
2020-09-16 |
Fever |
N |
TRUE |
FALSE |
TRUE |
| 10471092 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-31 |
2020-08-31 |
2020-09-21 |
1 |
2020-09-22 |
Fever 100.1 |
N |
2020-09-22 |
increased body temperature 100.1 |
N |
TRUE |
FALSE |
TRUE |
| 10471133 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-04 |
2020-09-04 |
2020-09-25 |
1 |
2020-09-26 |
Mild Fever 100.0 |
N |
2020-09-26 |
Increased body temperature 100.0 |
N |
TRUE |
FALSE |
TRUE |
| 10471170 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-09 |
2020-09-09 |
2020-10-01 |
1 |
2020-09-09 |
Left deltoid Soreness post injection |
N |
2020-09-09 |
injection site Left deltoid Soreness |
N |
TRUE |
FALSE |
TRUE |
| 10471223 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-16 |
2020-09-16 |
2020-10-08 |
2 |
2020-10-08 |
Low Grade Fever 99.1 |
N |
2020-10-08 |
increased body temperture 99.1 |
N |
TRUE |
FALSE |
TRUE |
| 10481096 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-08 |
2020-09-08 |
2020-09-30 |
1 |
2020-09-08 |
FLU-LIKE SYMPTOMS |
N |
2020-09-08 |
general malaise |
N |
TRUE |
FALSE |
TRUE |
| 10541021 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-21 |
2020-08-21 |
2020-09-10 |
1 |
2020-08-24 |
right hip pain |
N |
2020-08-24 |
worsening of right hip pain |
N |
TRUE |
FALSE |
TRUE |
| 10541073 |
Placebo |
2020-08-28 |
2020-08-28 |
2020-09-18 |
2 |
2020-09-11 |
rash, L arm |
N |
2020-09-11 |
fungal skin infection L arm |
N |
TRUE |
FALSE |
TRUE |
| 10541173 |
Placebo |
2020-09-18 |
2020-09-18 |
2020-10-09 |
1 |
2020-10-28 |
acute severe aortic insufficiency |
Y |
2020-10-28 |
subacute bacterial endocarditis |
Y |
TRUE |
FALSE |
TRUE |
| 10541173 |
Placebo |
2020-09-18 |
2020-09-18 |
2020-10-09 |
2 |
2020-10-28 |
pain L hamstring |
N |
2020-10-28 |
pain L hamstring muscles |
N |
TRUE |
FALSE |
TRUE |
| 10541201 |
Placebo |
2020-10-22 |
2020-10-22 |
2020-11-20 |
1 |
2020-10-24 |
intermittent diffuse muscle pain |
N |
2020-10-22 |
body aches |
N |
FALSE |
FALSE |
TRUE |
| 10541201 |
Placebo |
2020-10-22 |
2020-10-22 |
2020-11-20 |
2 |
2020-10-22 |
headache |
N |
2020-10-22 |
intermittent headache |
N |
TRUE |
FALSE |
TRUE |
| 10551145 |
Placebo |
2020-08-28 |
2020-08-28 |
— |
2 |
2020-10-10 |
Right upper extremity pain |
N |
2020-10-10 |
Bilateral upper extremity pain |
N |
TRUE |
FALSE |
TRUE |
| 10551182 |
Placebo |
2020-09-03 |
2020-09-03 |
2020-09-25 |
1 |
2020-09-25 |
Basal Cell Cancer |
N |
2020-11-16 |
Melanoma |
Y |
FALSE |
FALSE |
FALSE |
| 10571327 |
Placebo |
2020-10-16 |
2020-10-16 |
2020-11-04 |
1 |
2020-10-22 |
PENTONSILLAR ABSESS |
Y |
2020-10-22 |
LEFT PERITONSILLAR ABSCESS |
Y |
TRUE |
FALSE |
TRUE |
| 10681017 |
Placebo |
2020-08-20 |
2020-08-20 |
2020-09-09 |
|
2020-08-20 |
administered incorrect dosage at vaccination 1 |
|
2020-08-20; 2021-01-08 |
administered incorrect dosage at vaccination 1 | Administration of correct study intervention from incorrect container (product administration error) |
|
FALSE |
FALSE |
TRUE |
| 10681036 |
Placebo |
2020-08-24 |
2020-08-24 |
2020-09-16 |
|
2020-08-24 |
administered incorrect dosage at vaccination 1 |
|
2020-08-24; 2021-01-08 |
administered incorrect dosage at vaccination 1 | Administration of correct study intervention from incorrect container (product administration error) |
|
FALSE |
FALSE |
TRUE |
| 10681050 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-27 |
2020-08-27 |
2020-09-18 |
2 |
2020-08-27 |
Sore left arm |
N |
2020-08-27 |
Injection site pain, left arm |
N |
TRUE |
FALSE |
TRUE |
| 10681092 |
Placebo |
2020-09-02 |
2020-09-02 |
2020-09-23 |
1 |
2020-09-04 |
ED visit nephrolithiasis |
N |
2020-09-04 |
nephrolithiasis |
N |
TRUE |
FALSE |
TRUE |
| 10681121 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-23 |
2020-09-23 |
2020-10-27 |
1 |
2020-10-27 |
pain in left arm |
N |
2020-10-27 |
injection site pain in left arm |
N |
TRUE |
FALSE |
TRUE |
| 10711171 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-15 |
2020-09-15 |
2020-10-05 |
1 |
2020-10-07 |
SWOLLEN LYMPHNODE UNDER LEFT ARMPIT |
N |
2020-10-07 |
SWOLLEN LYMPH NODE UNDER LEFT ARMPIT |
N |
TRUE |
FALSE |
TRUE |
| 10771090 |
Placebo |
2020-08-24 |
2020-08-24 |
2020-09-14 |
1 |
2020-10-17 |
ACUTE NEURALGIA |
N |
2020-10-17 |
ACUTE DIFFUSE NEURALGIA |
N |
TRUE |
FALSE |
TRUE |
| 10791039 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-03 |
2020-08-03 |
2020-08-25 |
|
2020-08-03; 2020-08-26 |
HEADACHE | PAIN AT INJECTION SITE |
|
2020-08-03; 2020-08-26 |
Administration of correct study intervention from incorrect container (product administration error) | HEADACHE | PAIN AT INJECTION SITE |
|
TRUE |
FALSE |
TRUE |
| 10791042 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-03 |
2020-08-03 |
2020-08-25 |
|
2020-08-09 |
JOINT PAIN | MUSCLE PAIN |
|
2020-08-03; 2020-08-09 |
Administration of correct study intervention from incorrect container (product administration error) | JOINT PAIN | MUSCLE PAIN |
|
FALSE |
FALSE |
TRUE |
| 10791264 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-09 |
2020-09-09 |
2020-11-04 |
1 |
2020-09-27 |
low back pain |
N |
2020-09-27 |
Worsening of Low Back Pain |
N |
TRUE |
FALSE |
TRUE |
| 10801045 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-17 |
2020-08-17 |
2020-09-08 |
1 |
2020-09-08 |
Soreness - Right Arm |
N |
2020-09-08 |
Injection site pain - Right Arm |
N |
TRUE |
FALSE |
TRUE |
| 10811046 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-17 |
2020-08-17 |
2020-09-09 |
1 |
2020-09-17 |
Hyperglycemic episode |
Y |
2020-09-17 |
Diabetic Ketoacidosis |
Y |
TRUE |
FALSE |
TRUE |
| 10811061 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-18 |
2020-08-18 |
2020-09-03 |
1 |
2020-09-10 |
Lymphadenopathy |
N |
2020-09-10 |
Lymphadenopathy Under left ear |
N |
TRUE |
FALSE |
TRUE |
| 10811107 |
Placebo |
2020-08-26 |
2020-08-26 |
2020-09-16 |
1 |
2020-10-07 |
Idiopathic chest pain |
N |
2020-10-06 |
non cardiac chest pain |
N |
FALSE |
FALSE |
TRUE |
| 10831084 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-11 |
2020-08-11 |
2020-08-31 |
1 |
2020-08-17 |
Bruised Right Meniscus |
N |
2020-08-17 |
Torn Meniscus-Right |
N |
TRUE |
FALSE |
TRUE |
| 10841158 |
Placebo |
2020-08-14 |
2020-08-14 |
2020-09-04 |
1 |
2020-09 |
worsening skin fungal infection to groin area |
N |
2020-09 |
Fungal infection to groin area |
N |
TRUE |
FALSE |
TRUE |
| 10841480 |
Placebo |
2020-10-14 |
2020-10-14 |
2020-11-02 |
1 |
2020-10-26 |
MYOCARDIAL INFARCTION |
Y |
2020-10-26 |
ST-segment elevated MYOCARDIAL INFARCTION |
Y |
TRUE |
FALSE |
TRUE |
| 10871029 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-07 |
2020-08-07 |
2020-08-26 |
1 |
2020-10-28 |
Confusion |
Y |
2020-10-28 |
Acute Toxic Metabolic Encephalopathy |
Y |
TRUE |
FALSE |
TRUE |
| 10871422 |
Placebo |
2020-09-11 |
2020-09-11 |
2020-10-02 |
1 |
2020-09-12 |
MUSCLE PAIN |
N |
2020-09-12 |
GENERALIZED RIGHT ARM MUSCLE PAIN |
N |
TRUE |
FALSE |
TRUE |
| 10871422 |
Placebo |
2020-09-11 |
2020-09-11 |
2020-10-02 |
2 |
2020-09-12 |
MUSCLE SPASM |
N |
2020-09-12 |
RIGHT ARM MUSCLE SPASM |
N |
TRUE |
FALSE |
TRUE |
| 10891261 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-08 |
2020-09-08 |
2020-09-30 |
1 |
2020-09-19 |
shingles right bottom |
N |
2020-09-19 |
worsening shingles right bottom |
N |
TRUE |
FALSE |
TRUE |
| 10901536 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-23 |
2020-10-23 |
2020-11-13 |
2 |
2020-10-24 |
Body aches |
N |
2020-10-24 |
Myalgia |
N |
TRUE |
FALSE |
TRUE |
| 10911269 |
Placebo |
2020-09-09 |
2020-09-09 |
2020-09-29 |
10 |
2020-09-19 |
Bacterial infection of tooth |
N |
2020-09-19 |
Infection of tooth |
N |
TRUE |
FALSE |
TRUE |
| 10921186 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-14 |
2020-09-14 |
2020-10-05 |
1 |
2020-11-02 |
continuous left knee pain |
N |
2020-11-02 |
worsening osteoarthritis |
N |
TRUE |
FALSE |
TRUE |
| 10951170 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-29 |
2020-08-29 |
2020-09-17 |
1 |
2020-08-29 |
Post vaccination reaction headache |
N |
2020-08-29 |
Headache |
N |
TRUE |
FALSE |
TRUE |
| 10951170 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-29 |
2020-08-29 |
2020-09-17 |
2 |
2020-08-30 |
injection site reaction left arm |
N |
2020-08-30 |
Injection site pain left arm |
N |
TRUE |
FALSE |
TRUE |
| 10951212 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-02 |
2020-09-02 |
2020-09-21 |
3 |
2020-09-22 |
post vaccination malaise |
N |
2020-09-22 |
malaise |
N |
TRUE |
FALSE |
TRUE |
| 10951278 |
Placebo |
2020-10-12 |
2020-10-12 |
2020-11-03 |
1 |
2020-10-19 |
Right leg anterior abscess with adjacent cellulitis due to spider bite |
N |
2020-10-19 |
Right leg anterior abscess |
N |
TRUE |
FALSE |
TRUE |
| 10961031 |
Placebo |
2020-08-14 |
2020-08-14 |
— |
2 |
2020-08-14 |
PREGNANCY |
N |
2020-08-14 |
EXPOSURE DURING PREGNANCY |
N |
TRUE |
FALSE |
TRUE |
| 10961062 |
Placebo |
2020-08-19 |
2020-08-19 |
2020-09-09 |
1 |
2020-10-04 |
Bilateral Lower extremity paralysis |
Y |
2020-10-04 |
bilateral lower extremity weakness |
Y |
TRUE |
FALSE |
TRUE |
| 10961097 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-22 |
2020-08-22 |
2020-09-12 |
2 |
2020-09-13 |
rash on body |
N |
2020-09-13 |
generalized rash on body |
N |
TRUE |
FALSE |
TRUE |
| 10961264 |
Placebo |
2020-09-05 |
2020-09-05 |
2020-09-25 |
2 |
2020-10-26 |
generalized body aches due to mva |
N |
2020-10-26 |
generalized body aches |
N |
TRUE |
FALSE |
TRUE |
| 10971061 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-28 |
2020-08-28 |
2020-09-17 |
1 |
2020-10-22 |
uremic encephalopathy |
Y |
2020-10-22 |
Uremic encephalopathy |
Y |
TRUE |
FALSE |
TRUE |
| 10971084 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-01 |
2020-09-01 |
2020-09-23 |
1 |
2020-10-07 |
Pneumonia |
Y |
2020-09-29 |
Urinary Tract Infection |
Y |
FALSE |
FALSE |
TRUE |
| 10981024 |
Placebo |
2020-08-21 |
2020-08-21 |
2020-09-24 |
1 |
2020-10-07 |
ChestPain due to community Acquired Pneumonia |
Y |
2020-10-07 |
ChestPain |
Y |
TRUE |
FALSE |
TRUE |
| 10981024 |
Placebo |
2020-08-21 |
2020-08-21 |
2020-09-24 |
9 |
2020-10-07 |
COPD without acute exacerbation |
N |
2020-10-07 |
COPD with acute exacerbation |
N |
TRUE |
FALSE |
TRUE |
| 11011060 |
Placebo |
2020-09-15 |
2020-09-15 |
2020-10-06 |
1 |
2020-09-18 |
vomiting |
N |
2020-09-18 |
GASTROENTERITIS |
N |
TRUE |
FALSE |
TRUE |
| 11091473 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-09 |
2020-09-09 |
2020-09-29 |
1 |
2020-09-30 |
FEVER |
N |
2020-09-30 |
FEVER 101F |
N |
TRUE |
FALSE |
TRUE |
| 11101150 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-27 |
2020-08-27 |
2020-09-16 |
1 |
2020-10-14 |
pain to right fifth finger |
N |
2020-10-14 |
avulsion flexor distal phalanx injury |
N |
TRUE |
FALSE |
TRUE |
| 11121101 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-10 |
2020-08-10 |
2020-10-02 |
2 |
2020-10-22 |
Shoulder Pain, left |
N |
2020-10-22 |
Bursitis, left shoulder |
N |
TRUE |
FALSE |
TRUE |
| 11161045 |
Placebo |
2020-08-28 |
2020-08-28 |
2020-09-18 |
3 |
2020-10-28 |
Bleeding of unknown source |
Y |
2020-10-27 |
Thrombocytopenia |
Y |
FALSE |
FALSE |
TRUE |
| 11161131 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-04 |
2020-09-04 |
2020-09-23 |
3 |
2020-09-10 |
Muscle Pain |
N |
2020-09-10 |
Generalized Muscle Pain |
N |
TRUE |
FALSE |
TRUE |
| 11171007 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-17 |
2020-08-17 |
2020-09-08 |
5 |
2020-10-01 |
RECURRENT SEBACEOUS CYST REMOVAL |
N |
2020-10-01 |
RECURRENT SEBACEOUS CYST, UPPER BACK |
N |
TRUE |
FALSE |
TRUE |
| 11171042 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-24 |
2020-08-24 |
2020-09-14 |
2 |
2020-10-12 |
FATIQUE |
N |
2020-10-12 |
FATIGUE |
N |
TRUE |
FALSE |
TRUE |
| 11171102 |
Placebo |
2020-09-04 |
2020-09-04 |
2020-10-02 |
1 |
2020-09-17 |
ADHD |
N |
2020-09-17 |
ADHD, WORSENING |
N |
TRUE |
FALSE |
TRUE |
| 11171186 |
Placebo |
2020-10-06 |
2020-10-06 |
— |
2 |
2020-10-19 |
SUICIDAL ATTEMPT |
Y |
2020-10-19 |
SUICIDAL IDEATION WITH ATTEMPT |
Y |
TRUE |
FALSE |
TRUE |
| 11181074 |
Placebo |
2020-08-20 |
2020-08-20 |
2020-09-11 |
1 |
2020-09-14 |
chest wall pain |
Y |
2020-09-14 |
BRADYCARDIA |
Y |
TRUE |
FALSE |
TRUE |
| 11231025 |
Placebo |
2020-08-03 |
2020-08-03 |
2020-08-24 |
1 |
2020-08-24 |
RIGHT EYE CONJUNCTIVE ERYTHEMA |
N |
2020-08-24 |
INTERMITTENT RIGHT EYE CONJUNCTIVE ERYTHEMA |
N |
TRUE |
FALSE |
TRUE |
| 11231237 |
Placebo |
2020-09-11 |
2020-09-11 |
2020-10-02 |
1 |
2020-09-30 |
Wisdom tooth eruption |
N |
2020-09-30 |
Wisdom tooth eruption with pain |
N |
TRUE |
FALSE |
TRUE |
| 11231365 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-12 |
2020-10-12 |
2020-11-02 |
1 |
2020-11-02 |
Injection site itchiness |
N |
2020-11-02 |
Injection site pruritus |
N |
TRUE |
FALSE |
TRUE |
| 11241047 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-17 |
2020-08-17 |
2020-09-10 |
1 |
2020-09-13 |
Muscle Soreness at vaccination site |
N |
2020-09-13 |
Muscle Soreness at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11251181 |
Placebo |
2020-09-08 |
2020-09-08 |
2020-09-29 |
1 |
2020-10-22 |
Ovarian Cyst |
N |
2020-10-22 |
Right Ovarian Cyst |
N |
TRUE |
FALSE |
TRUE |
| 11281014 |
Placebo |
2020-07-31 |
2020-07-31 |
2020-08-27 |
2 |
2020-08-28 |
Fall |
N |
2020-08-28 |
FACIAL LACERATIONS |
N |
TRUE |
FALSE |
TRUE |
| 11281014 |
Placebo |
2020-07-31 |
2020-07-31 |
2020-08-27 |
3 |
2020-08-28 |
Facial Lacerations |
Y |
2020-08-28 |
Fall |
Y |
TRUE |
FALSE |
TRUE |
| 11281101 |
Placebo |
2020-08-12 |
2020-08-12 |
2020-08-31 |
1 |
2020-08-15 |
Bilateral Knee Pain |
N |
2020-08-15 |
Bilateral Knee Pain (Patellar Tendonitis) |
N |
TRUE |
FALSE |
TRUE |
| 11281103 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-12 |
2020-08-12 |
2020-09-01 |
2 |
2020-10-03 |
Low potassium |
Y |
2020-10-03 |
Severe Hypokalemia |
Y |
TRUE |
FALSE |
TRUE |
| 11281103 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-12 |
2020-08-12 |
2020-09-01 |
3 |
2020-10-03 |
GASTROENTERITIS |
Y |
2020-10-03 |
Escherichia coli urinary tract infection |
Y |
TRUE |
FALSE |
TRUE |
| 11281143 |
Placebo |
2020-08-18 |
2020-08-18 |
2020-09-10 |
2 |
2020-09-18 |
Bilateral LEG PAIN |
N |
2020-09-18 |
Bilateral LEG muscle strain |
N |
TRUE |
FALSE |
TRUE |
| 11291029 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-03 |
2020-08-03 |
2020-08-24 |
1 |
2020-09-30 |
recurrence of historic infected blocked pore on vulva |
N |
2020-09-30 |
worsening furuncle vulva |
N |
TRUE |
FALSE |
TRUE |
| 11291222 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-12 |
2020-10-12 |
2020-11-03 |
1 |
2020-11-03 |
vaccine reactogenicity |
N |
2020-11-03 |
chills |
N |
TRUE |
FALSE |
TRUE |
| 11301039 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-03 |
2020-09-03 |
2020-09-30 |
1 |
2020-09-11 |
microscopic colitis |
N |
2020-09-11 |
worsening microscopic colitis |
N |
TRUE |
FALSE |
TRUE |
| 11311057 |
Placebo |
2020-08-21 |
2020-08-21 |
2020-09-11 |
1 |
2020-09-30 |
shingles |
N |
2020-09-30 |
shingles multidermatomal |
N |
TRUE |
FALSE |
TRUE |
| 11311140 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-04 |
2020-09-04 |
2020-09-24 |
3 |
2020-09-25 |
joint pain |
N |
2020-09-25 |
generalized joint pain |
N |
TRUE |
FALSE |
TRUE |
| 11311149 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-08 |
2020-09-08 |
2020-09-29 |
1 |
2020-09-09 |
basal cell carcinoma |
N |
2020-09-09 |
basal cell carcinoma (right fore arm, left temple) |
N |
TRUE |
FALSE |
TRUE |
| 11311156 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-09 |
2020-09-09 |
2020-09-28 |
1 |
2020-09-17 |
joint pain |
N |
2020-09-17 |
joint pain in hands |
N |
TRUE |
FALSE |
TRUE |
| 11331207 |
Placebo |
2020-08-19 |
2020-08-19 |
— |
1 |
2020-08-20 |
Pregnacy |
N |
2020-08-20 |
Exposure During Pregnacy |
N |
TRUE |
FALSE |
TRUE |
| 11351045 |
Placebo |
2020-08-06 |
2020-08-06 |
2020-08-25 |
1 |
2020-10-04 |
lower limb cellulitis |
N |
2020-10-04 |
right lower limb cellulitis |
N |
TRUE |
FALSE |
TRUE |
| 11351052 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-07 |
2020-08-07 |
2020-08-27 |
1 |
2020-08-28 |
foot ulcer |
N |
2020-08-28 |
right foot ulcer |
N |
TRUE |
FALSE |
TRUE |
| 11351333 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-09 |
2020-09-09 |
2020-09-28 |
1 |
2020-10-27 |
right eye cataract surgery |
N |
2020-10-27 |
right eye cataract |
N |
TRUE |
FALSE |
TRUE |
| 11411122 |
Placebo |
2020-08-24 |
2020-08-24 |
2020-09-14 |
1 |
2020-09-21 |
cough |
N |
2020-09-21 |
Exacerbation of seasonal allergies |
N |
TRUE |
FALSE |
TRUE |
| 11411134 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-26 |
2020-08-26 |
2020-09-15 |
1 |
2020-08-26 |
Site of vaccination painful arm |
N |
2020-08-26 |
injection site pain |
N |
TRUE |
FALSE |
TRUE |
| 11411179 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-08 |
2020-09-08 |
2020-09-22 |
4 |
2020-09-23 |
tender lymph node axillary |
N |
2020-09-23 |
tender left lymph node axillary |
N |
TRUE |
FALSE |
TRUE |
| 11421161 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-31 |
2020-08-31 |
2020-09-21 |
1 |
2020-09-21 |
injection site reaction |
N |
2020-09-21 |
Soreness at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11421177 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-02 |
2020-09-02 |
2020-09-23 |
1 |
2020-09-02 |
vaccine site pain (left deltoid) |
N |
2020-09-02 |
injection site pain (left deltoid) |
N |
TRUE |
FALSE |
TRUE |
| 11421177 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-02 |
2020-09-02 |
2020-09-23 |
2 |
2020-09-24 |
vaccine site pain (left deltoid) |
N |
2020-09-24 |
injection site pain (left deltoid) |
N |
TRUE |
FALSE |
TRUE |
| 11451102 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-11 |
2020-09-11 |
2020-10-01 |
1 |
2020-09-11 |
Left Arm Muscle pain |
N |
2020-09-11 |
Left Arm injection site pain |
N |
TRUE |
FALSE |
TRUE |
| 11461161 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-31 |
2020-08-31 |
2020-09-21 |
1 |
2020-09-09 |
Left lower lobe pulmonary nodule |
Y |
2020-09-09 |
Interstitial Pneumonitis |
Y |
TRUE |
FALSE |
TRUE |
| 11461200 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-03 |
2020-09-03 |
2020-09-25 |
1 |
2020-09-27 |
Loss of consciousness |
Y |
2020-09-27 |
syncope |
Y |
TRUE |
FALSE |
TRUE |
| 11491200 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-04 |
2020-09-04 |
2020-09-25 |
1 |
2020-09-05 |
left arm pain |
N |
2020-09-05 |
left arm pain at injection site. |
N |
TRUE |
FALSE |
TRUE |
| 11491200 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-04 |
2020-09-04 |
2020-09-25 |
4 |
2020-09-26 |
left arm pain |
N |
2020-09-26 |
left arm pain at injection site. |
N |
TRUE |
FALSE |
TRUE |
| 11501003 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-17 |
2020-08-17 |
2020-09-08 |
1 |
2020-09-08 |
Arm Soreness (Left Arm) |
N |
2020-09-08 |
Pain at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11501005 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-18 |
2020-08-18 |
2020-09-09 |
4 |
2020-09-10 |
Arm Soreness (Left arm) |
N |
2020-09-10 |
Pain at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11501011 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-18 |
2020-08-18 |
2020-09-09 |
5 |
2020-09-09 |
Arm pain/soreness (Left arm) |
N |
2020-09-09 |
Injection Site Pain |
N |
TRUE |
FALSE |
TRUE |
| 11501016 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-19 |
2020-08-19 |
2020-09-11 |
1 |
2020-09-12 |
Arm Soreness (Right arm) |
N |
2020-09-12 |
Injection Site Soreness |
N |
TRUE |
FALSE |
TRUE |
| 11501017 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-19 |
2020-08-19 |
2020-09-11 |
1 |
2020-09-12 |
Arm Soreness (Left arm) |
N |
2020-09-12 |
Pain at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11501018 |
Placebo |
2020-08-19 |
2020-08-19 |
2020-09-10 |
2 |
2020-09-10 |
Arm Soreness (Left arm) |
N |
2020-09-10 |
Pain at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11501027 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-20 |
2020-08-20 |
2020-09-09 |
2 |
2020-09-10 |
Arm Soreness (Left Arm) |
N |
2020-09-10 |
Pain at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11501037 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-24 |
2020-08-24 |
2020-09-14 |
2 |
2020-09-15 |
Arm Soreness (Left arm) |
N |
2020-09-15 |
Pain at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11501060 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-27 |
2020-08-27 |
2020-09-18 |
2 |
2020-09-18 |
Left arm soreness |
N |
2020-09-18 |
Pain at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11501063 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-27 |
2020-08-27 |
2020-09-16 |
1 |
2020-08-27 |
Left arm soreness |
N |
2020-08-27 |
Pain at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11501073 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-31 |
2020-08-31 |
2020-09-21 |
1 |
2020-08-31 |
arm soreness (left arm) |
N |
2020-08-31 |
Pain at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11501101 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-03 |
2020-09-03 |
2020-09-23 |
1 |
2020-09-04 |
arm soreness (L arm) |
N |
2020-09-04 |
Pain at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11501113 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-11 |
2020-09-11 |
2020-09-30 |
1 |
2020-09-12 |
Arm Pain (Left arm) |
N |
2020-09-12 |
Pain at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11501114 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-11 |
2020-09-11 |
2020-09-30 |
1 |
2020-09-12 |
Arm Soreness (Left arm) |
N |
2020-09-12 |
Pain at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11521085 |
Placebo |
2020-08-19 |
2020-08-19 |
— |
1 |
2020-08-26 |
Unknown of Unknown Origin |
Y |
2020-08-26 |
UNDETERMINED CAUSE OF DEATH |
Y |
TRUE |
FALSE |
TRUE |
| 11521260 |
Placebo |
2020-08-31 |
2020-08-31 |
2020-09-21 |
1 |
2020-09-04 |
melanoma left shoulder |
Y |
2020-09-04 |
malignant melanoma |
Y |
TRUE |
FALSE |
TRUE |
| 11571115 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-01 |
2020-09-01 |
2020-09-23 |
2 |
2020-09-24 |
Body Aches (back and Shoulders) |
N |
2020-09-24 |
Body Aches |
N |
TRUE |
FALSE |
TRUE |
| 11571134 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-02 |
2020-09-02 |
2020-09-24 |
1 |
2020-10-27 |
Cerebrovascular Attack |
Y |
2020-10-27 |
Suspected Transient Ischemic Attack |
Y |
TRUE |
FALSE |
TRUE |
| 11621025 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-04 |
2020-08-04 |
2020-08-25 |
1 |
2020-08-13 |
Esophageal pain |
N |
2020-08-13 |
Esophageal pain/Acid Reflux |
N |
TRUE |
FALSE |
TRUE |
| 11621158 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-18 |
2020-08-18 |
2020-09-09 |
4 |
2020-09-10 |
Left shoulder soreness |
N |
2020-09-10 |
Left shoulder soreness (injection site pain) |
N |
TRUE |
FALSE |
TRUE |
| 11631003 |
Placebo |
2020-07-31 |
2020-07-31 |
2020-08-19 |
|
2020-07-31 |
potential administration of study intervention after expiry window (Expired drug administered) |
|
2020-07-31 |
Unknown study product administered (drug administration error) |
|
TRUE |
FALSE |
TRUE |
| 11631007 |
Placebo |
2020-07-31 |
2020-07-31 |
2020-08-20 |
|
2020-07-31 |
potential administration of study intervention after expiry window (Expired drug administered) |
|
2020-07-31 |
Unknown study product administered (drug administration error) |
|
TRUE |
FALSE |
TRUE |
| 11631059 |
Placebo |
2020-08-07 |
2020-08-07 |
— |
1 |
2020-08-08 |
ALLERGIC REACTION to study vaccine |
N |
2020-08-08 |
Allergic Reaction to study investigational product |
N |
TRUE |
FALSE |
TRUE |
| 11631059 |
Placebo |
2020-08-07 |
2020-08-07 |
— |
2 |
2020-08-08 |
Upper Body Rash (redness) |
N |
2020-08-08 |
Allergic Reaction upper body rash |
N |
TRUE |
FALSE |
TRUE |
| 11631096 |
Placebo |
2020-08-12 |
2020-08-12 |
2020-09-02 |
|
2020-08-12 |
potential administration of study intervention after expiry window (Expired drug administered) |
|
2020-08-12 |
Unknown study product administered (drug administration error) |
|
TRUE |
FALSE |
TRUE |
| 11661076 |
Placebo |
2020-09-15 |
2020-09-15 |
2020-10-05 |
1 |
2020-09-25 |
SUPERFICIAL ABRAISIONS, dorsal wrists, left. Secondary to MOTOR VEHICLE ACCIDENT (MVA). |
N |
2020-09-25 |
SUPERFICIAL ABRAISIONS, dorsal wrists, left |
N |
TRUE |
FALSE |
TRUE |
| 11691042 |
Placebo |
2020-09-14 |
2020-09-14 |
2020-10-05 |
2 |
2020-10-22 |
Painfull Shoulder |
N |
2020-10-22 |
Painfull Right Shoulder |
N |
TRUE |
FALSE |
TRUE |
| 11701207 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-04 |
2020-09-04 |
2020-09-25 |
1 |
2020-09-25 |
Redness |
N |
2020-09-25 |
Injection site Redness |
N |
TRUE |
FALSE |
TRUE |
| 11701217 |
Placebo |
2020-09-08 |
2020-09-08 |
2020-09-29 |
1 |
2020-09-12 |
Cellulitis of Left Lower extremity |
Y |
2020-10-01 |
Cellulitis of left lower leg |
Y |
FALSE |
FALSE |
TRUE |
| 11701245 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-09 |
2020-09-09 |
2020-10-02 |
5 |
2020-10-02 |
Redness |
N |
2020-10-02 |
Redness at injection site |
N |
TRUE |
FALSE |
TRUE |
| 11701307 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-11 |
2020-09-11 |
2020-10-02 |
6 |
2020-10-03 |
Joint Pain |
N |
2020-10-02 |
Left Arm Pain |
N |
FALSE |
FALSE |
TRUE |
| 11701318 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-15 |
2020-09-15 |
2020-10-06 |
6 |
2020-09-15 |
Joint Pain |
N |
2020-09-15 |
Generalized Joint Pain |
N |
TRUE |
FALSE |
TRUE |
| 11771063 |
Placebo |
2020-08-17 |
2020-08-17 |
2020-09-08 |
1 |
2020-09-29 |
MELANOMA |
N |
2020-09-29 |
MELANOMA, Upper Back |
N |
TRUE |
FALSE |
TRUE |
| 11781048 |
Placebo |
2020-08-31 |
2020-08-31 |
2020-09-21 |
1 |
2020-09-20 |
salivary gland stone |
Y |
2020-09-20 |
Sialolithiasis |
Y |
TRUE |
FALSE |
TRUE |
| 11781103 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-04 |
2020-09-04 |
2020-09-24 |
2 |
2020-09-04 |
Left arm soreness |
N |
2020-09-04 |
Left arm soreness (injection site) |
N |
TRUE |
FALSE |
TRUE |
| 11781113 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-08 |
2020-09-08 |
2020-09-28 |
1 |
2020-09-08 |
Arm soreness - Right |
N |
2020-09-08 |
Arm soreness - Right (injection site) |
N |
TRUE |
FALSE |
TRUE |
| 11781263 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-28 |
2020-09-28 |
2020-10-20 |
3 |
2020-10-01 |
Sinus drainage |
N |
2020-10-01 |
post nasal drip |
N |
TRUE |
FALSE |
TRUE |
| 11951030 |
Placebo |
2020-10-16 |
2020-10-16 |
2020-11-04 |
1 |
2020-10-19 |
Lumboischialgie |
N |
2020-10-19 |
Lumboischialgia |
N |
TRUE |
FALSE |
TRUE |
| 11971019 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-16 |
2020-10-16 |
2020-11-04 |
1 |
2020-10-22 |
Suspicion of intermittend Hypotension |
N |
2020-10-22 |
lightheadedness |
N |
TRUE |
FALSE |
TRUE |
| 11971024 |
Placebo |
2020-10-16 |
2020-10-16 |
2020-11-04 |
|
2020-10-16 |
PAIN AT INJECTION SITE |
|
2020-10-16; 2020-11-05 |
FATIGUE | PAIN AT INJECTION SITE |
|
FALSE |
FALSE |
TRUE |
| 11971084 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-19 |
2020-10-19 |
2020-11-07 |
1 |
2020-10 |
Colon polyp |
N |
2020-10-27 |
Colon adenoma |
N |
FALSE |
FALSE |
TRUE |
| 12041055 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-08 |
2020-09-08 |
2020-09-28 |
1 |
2020-09-29 |
arm pain |
N |
2020-09-29 |
injection site pain |
N |
TRUE |
FALSE |
TRUE |
| 12041067 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-09 |
2020-09-09 |
2020-09-30 |
1 |
2020-09-30 |
left arm pain (vac #2 site) |
N |
2020-09-30 |
injection site pain |
N |
TRUE |
FALSE |
TRUE |
| 12041068 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-09 |
2020-09-09 |
2020-09-30 |
1 |
2020-09-30 |
sore arm |
N |
2020-09-30 |
Injection site pain |
N |
TRUE |
FALSE |
TRUE |
| 12041080 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-10 |
2020-09-10 |
2020-09-30 |
2 |
2020-09-30 |
left arm soreness (post administration of vaccine #2) |
N |
2020-09-30 |
Injection site pain (post administration of injection #2) |
N |
TRUE |
FALSE |
TRUE |
| 12041145 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-23 |
2020-09-23 |
2020-10-14 |
1 |
2020-09-23 |
arm pain |
N |
2020-09-23 |
Injection site pain |
N |
TRUE |
FALSE |
TRUE |
| 12041186 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-02 |
2020-10-02 |
2020-10-23 |
1 |
2020-10-31 |
syncope |
N |
2020-10-31 |
dehydration |
N |
TRUE |
FALSE |
TRUE |
| 12041213 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-12 |
2020-10-12 |
2020-11-02 |
1 |
2020-10-12 |
left arm soreness (vac 1 site) |
N |
2020-10-12 |
Injection site pain (vac 1 site) |
N |
TRUE |
FALSE |
TRUE |
| 12041220 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-12 |
2020-10-12 |
2020-11-02 |
1 |
2020-10-13 |
left arm pain |
N |
2020-10-13 |
injection site pain |
N |
TRUE |
FALSE |
TRUE |
| 12101002 |
Placebo |
2020-10-22 |
2020-10-22 |
2020-11-12 |
1 |
2020-10-27 |
Cold |
N |
2020-10-27 |
common cold |
N |
TRUE |
FALSE |
TRUE |
| 12231145 |
Placebo |
2020-09-09 |
2020-09-09 |
2020-09-30 |
1 |
2020-10-14 |
intermittent headaches |
N |
2020-10-14 |
tension headaches |
N |
TRUE |
FALSE |
TRUE |
| 12261174 |
Placebo |
2020-08-13 |
2020-08-13 |
2020-09-03 |
4 |
2020-10-25 |
herpes zoster |
N |
2020-10-25 |
multidermatomal herpes zoster |
N |
TRUE |
FALSE |
TRUE |
| 12261390 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-24 |
2020-08-24 |
2020-09-15 |
7 |
2020-09-18 |
Diarrhea |
N |
2020-09-18 |
Diarrhea intermittent |
N |
TRUE |
FALSE |
TRUE |
| 12261439 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-26 |
2020-08-26 |
2020-09-16 |
2 |
2020-08-27 |
Pain at vaccination site |
N |
2020-08-27 |
Pain at the injection site |
N |
TRUE |
FALSE |
TRUE |
| 12261707 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-14 |
2020-09-14 |
2020-10-05 |
2 |
2020-10-06 |
axillary lymphadenopathy |
N |
2020-10-06 |
axillary lymphadenopathy in the left arm |
N |
TRUE |
FALSE |
TRUE |
| 12261745 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-16 |
2020-09-16 |
2020-10-06 |
1 |
2020-09-23 |
left testicular tumor |
Y |
2020-09-23 |
Leydig cell tumor in left testicle |
Y |
TRUE |
FALSE |
TRUE |
| 12262004 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-10-01 |
2020-10-01 |
2020-10-22 |
2 |
2020-10-02 |
Fever |
N |
2020-10-02 |
Fever (38 C) |
N |
TRUE |
FALSE |
TRUE |
| 12311348 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-15 |
2020-08-15 |
2020-09-03 |
1 |
2020-08-15 |
local pain at the injection site |
N |
2020-08-15 |
Injection site pain |
N |
TRUE |
FALSE |
TRUE |
| 12311499 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-16 |
2020-08-16 |
2020-09-21 |
1 |
2020-09-10 |
myalgia in lower limbs |
N |
2020-09-10 |
PLANTAR FASCITIS |
N |
TRUE |
FALSE |
TRUE |
| 12311638 |
Placebo |
2020-08-16 |
2020-08-16 |
2020-09-08 |
1 |
2020-10-04 |
Cervicalgia |
N |
2020-10-04 |
cervical pain |
N |
TRUE |
FALSE |
TRUE |
| 12311689 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-17 |
2020-08-17 |
2020-09-09 |
2 |
2020-09-01 |
Edema |
N |
2020-09-01 |
Left ankle Edema |
N |
TRUE |
FALSE |
TRUE |
| 12311814 |
Placebo |
2020-08-17 |
2020-08-17 |
2020-09-08 |
1 |
2020-08-18 |
chronic urticaria |
N |
2020-08-18 |
Skin rash in the upper right thoracic region |
N |
TRUE |
FALSE |
TRUE |
| 12311815 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-17 |
2020-08-17 |
— |
1 |
2020-09-06 |
REACTIVE LYMPHOID PROLIFERATION |
N |
2020-09-06 |
REACTIVE LYMPHOID PROLIFERATION SUPRACLAVICULAR |
N |
TRUE |
FALSE |
TRUE |
| 12311825 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-17 |
2020-08-17 |
2020-10-05 |
1 |
2020-09-05 |
Migraine crysis |
N |
2020-09-05 |
Migraine crisis |
N |
TRUE |
FALSE |
TRUE |
| 12312024 |
Placebo |
2020-08-18 |
2020-08-18 |
2020-09-08 |
2 |
2020-09-27 |
Lower lip mucolele |
N |
2020-09-27 |
Lower lip mucocele |
N |
TRUE |
FALSE |
TRUE |
| 12312156 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-18 |
2020-08-18 |
2020-09-08 |
1 |
2020-08-29 |
SUBFEBRILE RECORD |
N |
2020-08-29 |
Body temperature increased |
N |
TRUE |
FALSE |
TRUE |
| 12312158 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-18 |
2020-08-18 |
2020-09-10 |
2 |
2020-08-19 |
Fever (up to 37.8 degrees Celcius) |
N |
2020-08-19 |
Body temperature increased |
N |
TRUE |
FALSE |
TRUE |
| 12312234 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-19 |
2020-08-19 |
2020-09-10 |
1 |
2020-09-11 |
Exacerbation of your underlying disease Psoriasis |
N |
2020-09-11 |
Psoriasis exacerbation |
N |
TRUE |
FALSE |
TRUE |
| 12312268 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-19 |
2020-08-19 |
2020-09-11 |
1 |
2020-09-27 |
bilateral hand arthralgias |
N |
2020-09-27 |
Bilateral hand tendinitis |
N |
TRUE |
FALSE |
TRUE |
| 12312268 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-19 |
2020-08-19 |
2020-09-11 |
2 |
2020-09-27 |
Right shoulder arthralgias |
N |
2020-09-27 |
Right shoulder tendinitis |
N |
TRUE |
FALSE |
TRUE |
| 12312372 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-19 |
2020-08-19 |
2020-10-09 |
4 |
2020-08-21 |
headache |
N |
2020-08-21 |
Intermittent Headache |
N |
TRUE |
FALSE |
TRUE |
| 12312464 |
Placebo |
2020-08-20 |
2020-08-20 |
2020-09-10 |
1 |
2020-10-15 |
Chronic headache |
N |
2020-09-17 |
Intermittent headache |
N |
FALSE |
FALSE |
TRUE |
| 12312477 |
Placebo |
2020-08-20 |
2020-08-20 |
2020-09-11 |
1 |
2020-08-26 |
allergic rhinitis |
N |
2020-08-26 |
worsening of allergic rhinitis |
N |
TRUE |
FALSE |
TRUE |
| 12312576 |
Placebo |
2020-08-20 |
2020-08-20 |
2020-09-09 |
1 |
2020-10-20 |
renal colic |
N |
2020-10-20 |
Renal colic |
N |
TRUE |
FALSE |
TRUE |
| 12312796 |
Placebo |
2020-08-21 |
2020-08-21 |
2020-09-09 |
1 |
2020-09-28 |
Dysphonia |
N |
2020-09-28 |
Worsening of dysphonia |
N |
TRUE |
FALSE |
TRUE |
| 12313205 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-22 |
2020-08-22 |
2020-09-10 |
1 |
2020-09-22 |
Worsening of lumbociatalgia |
N |
2020-09-22 |
Worsening of lumbosciatalgia |
N |
TRUE |
FALSE |
TRUE |
| 12313340 |
Placebo |
2020-08-23 |
2020-08-23 |
2020-09-11 |
1 |
2020-08-23 |
Hematoma in left deltoid. |
N |
2020-08-23 |
Injection site hematoma left deltoid |
N |
TRUE |
FALSE |
TRUE |
| 12313359 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-11-20 |
1 |
2020-09-23 |
column surgery at thoracic and lumbar levels |
N |
2020-09-23 |
Worsening of herniated discs |
N |
TRUE |
FALSE |
TRUE |
| 12313428 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
wrong IP dose |
|
TRUE |
FALSE |
TRUE |
| 12313429 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
wrong IP dose |
|
TRUE |
FALSE |
TRUE |
| 12313446 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313449 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313456 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313459 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313461 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313467 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313468 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313469 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313478 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313479 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313480 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313483 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313486 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313487 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313492 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
wrong IP dose |
|
TRUE |
FALSE |
TRUE |
| 12313496 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313497 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. Subject received 58mcg of IP |
|
TRUE |
FALSE |
TRUE |
| 12313498 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. Subject recieved a dose of 58 mcg. |
|
TRUE |
FALSE |
TRUE |
| 12313501 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313503 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
wrong IP dose |
|
TRUE |
FALSE |
TRUE |
| 12313505 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313506 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313508 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-17 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. Subject recieved approximately a 58 mcg dose. |
|
TRUE |
FALSE |
TRUE |
| 12313509 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313511 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-16 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313512 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of IP |
|
TRUE |
FALSE |
TRUE |
| 12313514 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313515 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-16 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose |
|
TRUE |
FALSE |
TRUE |
| 12313517 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313518 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313519 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313524 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
wrong IP dose. subject received 58mcg of IP |
|
TRUE |
FALSE |
TRUE |
| 12313528 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. Subject received approximately a 58 mcg dose. |
|
TRUE |
FALSE |
TRUE |
| 12313530 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject receive 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313533 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of IP |
|
TRUE |
FALSE |
TRUE |
| 12313534 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313536 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313537 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313538 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313541 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313542 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313546 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. Subject received approximately a 58 mcg dose. |
|
TRUE |
FALSE |
TRUE |
| 12313549 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-16 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. Subject recieved approximately a 58 mcg dose. |
|
TRUE |
FALSE |
TRUE |
| 12313551 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. |
|
TRUE |
FALSE |
TRUE |
| 12313553 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313554 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
— |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313556 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-16 |
|
2020-08-23 |
site administered the wrong investigational product. |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of IP |
|
TRUE |
FALSE |
TRUE |
| 12313562 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313564 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-15 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313567 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-17 |
|
2020-08-23 |
site administered the wrong investigational product |
|
2020-08-23 |
Wrong IP dose. subject received 58mcg of iP |
|
TRUE |
FALSE |
TRUE |
| 12313575 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-23 |
2020-08-23 |
2020-09-13 |
1 |
2020-08-24 |
Tendonitis |
N |
2020-08-24 |
Right forearm Tendinitis |
N |
TRUE |
FALSE |
TRUE |
| 12313608 |
Placebo |
2020-08-23 |
2020-08-23 |
2020-09-11 |
2 |
2020-09-16 |
Possible Carpal Tunnel Syndrome under study |
N |
2020-09-16 |
predominantly right bilateral carpal tunnel syndrome |
N |
TRUE |
FALSE |
TRUE |
| 12313636 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-24 |
2020-08-24 |
2020-09-14 |
1 |
2020-10-01 |
subfebrile record |
N |
2020-10-01 |
Body temperature increased |
N |
TRUE |
FALSE |
TRUE |
| 12313644 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-24 |
2020-08-24 |
2020-09-13 |
1 |
2020-10-06 |
Rash in the upper dorsal region |
N |
2020-10-06 |
Tinea Versicolor |
N |
TRUE |
FALSE |
TRUE |
| 12313651 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-24 |
2020-08-24 |
— |
1 |
2020-08-24 |
High blood pressure records |
N |
2020-10-16 |
Arterial Hypertension |
N |
FALSE |
FALSE |
TRUE |
| 12313674 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-24 |
2020-08-24 |
2020-09-13 |
1 |
2020-09-29 |
Nonspecific Pneumonitis |
Y |
2020-09-29 |
Non-specific Pneumonitis |
Y |
TRUE |
FALSE |
TRUE |
| 12313773 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-24 |
2020-08-24 |
2020-09-15 |
1 |
2020-08-24 |
Vaccine injection site pain |
N |
2020-08-24 |
Injection site pain |
N |
TRUE |
FALSE |
TRUE |
| 12313877 |
Placebo |
2020-08-25 |
2020-08-25 |
2020-09-16 |
1 |
2020-10-09 |
angina |
N |
2020-10-09 |
bacterial pharyngitis |
N |
TRUE |
FALSE |
TRUE |
| 12313877 |
Placebo |
2020-08-25 |
2020-08-25 |
2020-09-16 |
2 |
2020-10-09 |
left acute otitis media |
N |
2020-10-09 |
Left acute otitis media |
N |
TRUE |
FALSE |
TRUE |
| 12313894 |
Placebo |
2020-08-25 |
2020-08-25 |
2020-09-15 |
1 |
2020-10-16 |
hamstring tear (right leg) |
N |
2020-10-16 |
Right hamstring muscle tear |
N |
TRUE |
FALSE |
TRUE |
| 12313904 |
Placebo |
2020-08-25 |
2020-08-25 |
2020-09-13 |
2 |
2020-09-15 |
SUBFEBRILE RECORDS |
N |
2020-09-15 |
Body temperature increased |
N |
TRUE |
FALSE |
TRUE |
| 12314149 |
Placebo |
2020-08-26 |
2020-08-26 |
2020-09-14 |
2 |
2020-09-28 |
hip arthralgia |
N |
2020-08-30 |
Arthrosis |
N |
FALSE |
FALSE |
TRUE |
| 12314231 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-26 |
2020-08-26 |
2020-09-14 |
1 |
2020-10-09 |
Flare-up of chronic laryngitis |
N |
2020-10-09 |
Worsening of chronic laryngitis. |
N |
TRUE |
FALSE |
TRUE |
| 12314265 |
Placebo |
2020-08-26 |
2020-08-26 |
2020-09-15 |
1 |
2020-08-31 |
Arthalgies |
N |
2020-08-31 |
Synovitis in both knees |
N |
TRUE |
FALSE |
TRUE |
| 12314277 |
Placebo |
2020-08-26 |
2020-08-26 |
2020-09-16 |
1 |
2020-09-23 |
Temporomandibular dysfunction |
N |
2020-09-23 |
Temporomandibular joint dysfunction |
N |
TRUE |
FALSE |
TRUE |
| 12314407 |
Placebo |
2020-08-27 |
2020-08-27 |
2020-09-16 |
1 |
2020-09-20 |
Traumatic vertebral fractures in C2, T3, T4 and T5 |
Y |
2020-09-20 |
Polytrauma |
Y |
TRUE |
FALSE |
TRUE |
| 12314469 |
Placebo |
2020-08-27 |
2020-08-27 |
2020-09-15 |
1 |
2020-08-29 |
back pain |
N |
2020-08-29 |
low back pain |
N |
TRUE |
FALSE |
TRUE |
| 12314550 |
Placebo |
2020-08-27 |
2020-08-27 |
2020-09-16 |
1 |
2020-10-16 |
Pain in right upper limb |
N |
2020-10-16 |
Medial epicondylitis |
N |
TRUE |
FALSE |
TRUE |
| 12314690 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-28 |
2020-08-28 |
2020-09-16 |
1 |
2020-10-01 |
Flare-up of Gastroesophageal Reflux |
N |
2020-10-01 |
exacerbation of gastroesophageal reflux |
N |
TRUE |
FALSE |
TRUE |
| 12314833 |
Placebo |
2020-08-28 |
2020-08-28 |
2020-09-18 |
1 |
2020-10-16 |
appendicitis |
Y |
2020-10-16 |
Acute Appendicitis |
Y |
TRUE |
FALSE |
TRUE |
| 12314873 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-28 |
2020-08-28 |
2020-09-18 |
3 |
2020-10-23 |
herpes labialis |
N |
2020-10-23 |
Worsening of herpes labialis |
N |
TRUE |
FALSE |
TRUE |
| 12314953 |
Placebo |
2020-08-28 |
2020-08-28 |
2020-09-18 |
2 |
2020-10-30 |
ALLERGIC REACTION |
N |
2020-10-30 |
Pruritic rash in lower back, abdomen and neck. |
N |
TRUE |
FALSE |
TRUE |
| 12314961 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-28 |
2020-08-28 |
2020-09-16 |
1 |
2020-08-29 |
pain |
N |
2020-08-29 |
injection site pain |
N |
TRUE |
FALSE |
TRUE |
| 12314961 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-28 |
2020-08-28 |
2020-09-16 |
3 |
2020-08-29 |
local induration |
N |
2020-08-29 |
induration at injection site |
N |
TRUE |
FALSE |
TRUE |
| 12315185 |
Placebo |
2020-08-29 |
2020-08-29 |
2020-09-17 |
1 |
2020-09-16 |
Menstrual delay |
N |
2020-09-16 |
functional amenorrhea |
N |
TRUE |
FALSE |
TRUE |
| 12315190 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-29 |
2020-08-29 |
2020-09-17 |
1 |
2020-11-03 |
prechordalgia |
N |
2020-11-03 |
bronchial asthma |
N |
TRUE |
FALSE |
TRUE |
| 12315305 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-29 |
2020-08-29 |
2020-09-17 |
1 |
2020-09-17 |
local reactogenicity |
N |
2020-09-17 |
Injection site pain |
N |
TRUE |
FALSE |
TRUE |
| 12315322 |
Placebo |
2020-08-29 |
2020-08-29 |
2020-10-23 |
1 |
2020-09-16 |
Sciatica |
N |
2020-09-16 |
Worsening of Sciatica |
N |
TRUE |
FALSE |
TRUE |
| 12315404 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-30 |
2020-08-30 |
2020-10-08 |
1 |
2020-08-31 |
macroscopic haematuria |
N |
2020-08-31 |
Uncomplicated urinary infection |
N |
TRUE |
FALSE |
TRUE |
| 12315404 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-30 |
2020-08-30 |
2020-10-08 |
2 |
2020-10-10 |
Gross hematuria |
N |
2020-10-11 |
Exacerbation of gross hematuria |
N |
FALSE |
FALSE |
TRUE |
| 12315441 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-30 |
2020-08-30 |
— |
1 |
2020-09-10 |
depressive syndrome |
N |
2020-09-10 |
Depressive syndrome |
N |
TRUE |
FALSE |
TRUE |
| 12315453 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-30 |
2020-08-30 |
2020-09-19 |
1 |
2020-10-07 |
Clustered microcalcifications of the breast under study |
N |
2020-10-07 |
Breast ductal ectasia |
N |
TRUE |
FALSE |
TRUE |
| 12315504 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-30 |
2020-08-30 |
2020-09-18 |
1 |
2020-09-22 |
Aphthous stomatitis |
N |
2020-09-22 |
LICHENOID REACTION, in both jaw mucosa |
N |
TRUE |
FALSE |
TRUE |
| 12315520 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-30 |
2020-08-30 |
2020-09-19 |
1 |
2020-09-06 |
subfebrile syndrome |
N |
2020-09-06 |
Body temperature increased |
N |
TRUE |
FALSE |
TRUE |
| 12411510 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-01 |
2020-09-01 |
2020-09-21 |
3 |
2020-09-22 |
Edema at the vaccine site |
N |
2020-09-22 |
Injection site swelling |
N |
TRUE |
FALSE |
TRUE |
| 12411545 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-02 |
2020-09-02 |
2020-09-22 |
8 |
2020-09-23 |
Hypotension |
N |
2020-09-23 |
Lipothymia (Dizziness) |
N |
TRUE |
FALSE |
TRUE |
| 12411643 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-04 |
2020-09-04 |
2020-09-24 |
1 |
2020-10-24 |
Cholelithiasis |
Y |
2020-10-24 |
Acute cholecystitis |
Y |
TRUE |
FALSE |
TRUE |
| 12411862 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-17 |
2020-09-17 |
2020-10-06 |
3 |
2020-10-06 |
Lymph node enlargement in left arm |
N |
2020-10-06 |
Axillary lymph nodes enlargement in left arm |
N |
TRUE |
FALSE |
TRUE |
| 12481120 |
Placebo |
2020-09-11 |
2020-09-11 |
2020-10-21 |
1 |
2020-09-23 |
Mild Stroke |
Y |
2020-09-23 |
Acute Heart Failure |
Y |
TRUE |
FALSE |
TRUE |
| 12511081 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-31 |
2020-08-31 |
2020-10-05 |
1 |
2020-09-30 |
sinus congestion/wheezing |
N |
2020-09-30 |
sinus congestion |
N |
TRUE |
FALSE |
TRUE |
| 12511186 |
Placebo |
2020-09-18 |
2020-09-18 |
2020-10-09 |
1 |
2020-10-11 |
Rash Chin Elbows Knees Neck |
N |
2020-10-11 |
Rash Chin Elbows Knees Neck back |
N |
TRUE |
FALSE |
TRUE |
| 12541162 |
Placebo |
2020-09-18 |
2020-09-18 |
2020-10-07 |
1 |
2020-09-20 |
itching |
N |
2020-09-20 |
generalized itching |
N |
TRUE |
FALSE |
TRUE |
| 12611037 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-03 |
2020-09-03 |
2020-09-25 |
6 |
2020-10-23 |
Heartburn |
N |
2020-10-23 |
Heartburn r/t hiatal hernia |
N |
TRUE |
FALSE |
TRUE |
| 12611070 |
Placebo |
2020-09-10 |
2020-09-10 |
2020-10-01 |
2 |
2020-09-16 |
Canker sores |
N |
2020-09-16 |
Worsening frequency of canker sores |
N |
TRUE |
FALSE |
TRUE |
| 12641082 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-31 |
2020-08-31 |
2020-09-21 |
5 |
2020-09-21 |
Ventricular tachycardia |
N |
2020-09-21 |
Tachycardia |
N |
TRUE |
FALSE |
TRUE |
| 12641195 |
Placebo |
2020-09-22 |
2020-09-22 |
— |
3 |
2020-10-07 |
Pruritus |
N |
2020-10-07 |
Pruritus, abdomen |
N |
TRUE |
FALSE |
TRUE |
| 12641195 |
Placebo |
2020-09-22 |
2020-09-22 |
— |
4 |
2020-10-07 |
Rash maculo-papular |
N |
2020-10-07 |
Rash maculo-papular, abdomen |
N |
TRUE |
FALSE |
TRUE |
| 12641195 |
Placebo |
2020-09-22 |
2020-09-22 |
— |
7 |
2020-10-07 |
Dysguesia |
N |
2020-10-07 |
Dysgeusia |
N |
TRUE |
FALSE |
TRUE |
| 12651025 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-31 |
2020-08-31 |
2020-09-21 |
1 |
2020-08-31 |
Vaccination adverse reaction |
N |
2020-08-31 |
Mild flu-like sensation |
N |
TRUE |
FALSE |
TRUE |
| 12651026 |
Placebo |
2020-08-31 |
2020-08-31 |
2020-09-21 |
|
2020-08-31 |
Administration of incorrect study drug. |
|
2020-08-31 |
Administration of incorrect study intervention |
|
TRUE |
FALSE |
TRUE |
| 12651029 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-08-31 |
2020-08-31 |
2020-09-21 |
1 |
2020-09-01 |
Vaccination Adverse Reaction |
N |
2020-09-01 |
Chills |
N |
TRUE |
FALSE |
TRUE |
| 12651153 |
Placebo |
2020-09-21 |
2020-09-21 |
2020-10-13 |
2 |
2020-11-01 |
Right eye blindness |
N |
2020-11-01 |
Right eye blindness, diagnosed with Right Amaurosis Fugax |
N |
TRUE |
FALSE |
TRUE |
| 12701101 |
Placebo |
2020-09-14 |
2020-09-14 |
2020-10-05 |
1 |
2020-10-19 |
Worsening Epigastric Abdominal Pain |
N |
2020-10-19 |
Epigastric Abdominal Pain |
N |
TRUE |
FALSE |
TRUE |
| 44441158 |
Placebo |
2020-09-21 |
2020-09-21 |
2020-10-12 |
1 |
2020-10-01 |
Intentional fine tremor of the left hand lasting one to two minutes |
N |
2020-10-01 |
Unintentional fine tremor of the left hand lasting one to two minutes |
N |
TRUE |
FALSE |
TRUE |
| 44441249 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-21 |
2020-09-21 |
2020-10-12 |
1 |
2020-10-05 |
Right inguinal hernia |
Y |
2020-10-05 |
Incarcerated right inguinal hernia |
Y |
TRUE |
FALSE |
TRUE |
| 44441303 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-22 |
2020-09-22 |
2020-10-14 |
1 |
2020-09-29 |
Root canal |
N |
2020-09-29 |
dental caries |
N |
TRUE |
FALSE |
TRUE |
| 44441607 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-23 |
2020-09-23 |
2020-10-14 |
1 |
2020-11-02 |
Erysipelas |
N |
2020-11-02 |
Erysipelas in left leg |
N |
TRUE |
FALSE |
TRUE |
| 44441746 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-23 |
2020-09-23 |
2020-10-14 |
1 |
2020-10-15 |
Edema at the vaccine application site |
N |
2020-10-15 |
Edema at the injection site. |
N |
TRUE |
FALSE |
TRUE |
| 44442012 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-25 |
2020-09-25 |
2020-12-09 |
1 |
2020-10-31 |
right peripheral facial palsy |
N |
2020-10-31 |
Left peripheral facial palsy |
N |
TRUE |
FALSE |
TRUE |
| 44442032 |
Placebo |
2020-09-25 |
2020-09-25 |
2020-10-16 |
1 |
2020-10-04 |
Arthralgia in the hands |
N |
2020-10-04 |
Worsening of Hands arthralgia episode |
N |
TRUE |
FALSE |
TRUE |
| 44442163 |
BNT162b2 Phase 2/3 (30 mcg) |
2020-09-27 |
2020-09-27 |
2020-10-16 |
1 |
2020-10-17 |
fever 39.2 |
N |
2020-10-17 |
fever |
N |
TRUE |
FALSE |
TRUE |