125742 S1 M5 5351 c4591001 interim mth6 narrative sensitive

Document text

Compound: PF -07302048; Protocol: C4591001 Page 1of 157
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PFIZER CONFIDENTIAL  SDTM Creation:         . (.)  Source Data: adsl  Output File: ./nda2/C4591001_Narratives_Abbr/profile  D ate o f Generation: 
26MAR2021 (13:22)Table of Abbreviations
Category Abbreviation Text
Action -Subject N No action
O Other
P Drug withdrawn (study intervention discontinued)
TC Concomitant drug treatment given
TCN Concomitant non-drug treatment given
W Withdrawn from study
Toxicity Grade 1 Mild
2 Moderate
3 Severe
4 Life-threatening
System Organ Class BLOOD Blood and lymphatic system disorders
CARD Cardiac disorders
CONG Congenital, familial and genetic disorders
EAR Ear and labyrinth disorders
ENDO Endocrine disorders
EYE Eye disorders
GASTR Gastrointestinal disorders
GENRL General disorders and administration site conditions
HEPAT Hepatobiliary disorders
IMMUN Immune system disorders
INFEC Infections and infestations
INJ&P Injury poisoning and procedural complications
INV Investigations
METAB Metabolism and nutrition disorders
MUSC Musculoskeletal and connective tissue disorders
NEOPL Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NERV Nervous system disorders
PREG Pregnancy, puerperium and perinatal conditions
PSYCH Psychiatric disorders
RENAL Renal and urinary disorders
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Page 1
FDA-CBER-2021-5683-1016014
Compound: PF -07302048; Protocol: C4591001 Page 2of 157
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PFIZER CONFIDENTIAL  SDTM Creation:         . (.)  Source Data: adsl  Output File: ./nda2/C4591001_Narratives_Abbr/profile  D ate o f Generation: 
26MAR2021 (13:22)Table of Abbreviations
Category Abbreviation Text
REPRO Reproductive system and breast disorders
RESP Respiratory, thoracic and mediastinal disorders
SKIN Skin and subcutaneous tissue disorders
SOCCI Social circumstances
SURG Surgical and medical procedures
VASC Vascular disorders
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016015
Compound: PF -07302048; Protocol: C4591001 Page 3of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1007 10071101; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 30JUL2020; Date of Last Dose: 20AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1963 56 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
167.5 cm 129.6 kg 46.2 kg/m2 30JUL2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Obesity Obesity 2000 Present
Hypothyroidism Hypothyroidism NOV2007 Present
Depression Depression 2008 Present
Asthma Asthma 2009 Present
Sleep apnea Sleep apnoea syndrome 2013 Present
Gastroesophageal reflux Gastrooesophageal reflux disease 2018 Present
Gastric sleeve Gastrectomy SEP2019 Past
Supraventricular tachycardia Supraventricular tachycardia 08OCT2019 Past
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(b) (6)
FDA-CBER-2021-5683-1016016
Compound: PF -07302048; Protocol: C4591001 Page 4of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1007 10071101; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 30JUL2020; Date of Last Dose: 20AUG2020
==========================================================================================================================
PFIZER CONFI DENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 30JUL2020 (1) 13:11
2 BNT162b2 20AUG2020 (22) 11:45
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity 
GradeAction 
to 
Subject SAE
1 CARD Cardiac arrest Cardiac Arrest 18OCT2020 
(81)21OCT2020 
(84)4 4 W Y
Adverse Events
AE 
Number AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 Fatal 
(21OCT2020)NOT RELATED/OTHER: Heart attack. Occurred 2 months 
after last receipt of study agent2 60 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
Page 4
FDA-CBER-2021-5683-1016017
Compound: PF -07302048; Protocol: C4591001 Page 5of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1007 10071101; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 30JUL2020; Date of Last Dose: 20AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 30JUL2020
Completed VACCINATION 17SEP2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 21OCT2020 DEATH
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
Page 5
FDA-CBER-2021-5683-1016018
Compound: PF -07302048; Protocol: C4591001 Page 6of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1007 10071101; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 30JUL2020; Date of Last Dose: 20AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1007 10071101, a 56-year-old white female with a pertinent medical history of obesity (since 2000), hypothyroidism (since Nov 2007), depression 
(since 2008), asthma (since 2009), sleep apnea syndrome (since 2013), and supraventricular tachycardia (on 08 Oct2019), received Dose 1 on 30 Jul2020 and Dose 2 on 
20Aug 2020 (Day 22).  The subject experienced cardiac arrest on 18 Oct2020, 59 days after receiving Dose 2, and died of cardiac arrest on 21 Oct2020, 62 days after 
receiving Dose 2.
Concomitant medications included levothyroxine for hypothyroidism (since Nov 2007), albuterol for asthma (since 2016), citalopram for depression (since May 2017), 
metoprolol succinate for supraventricular tachycardia (since Oct 2019), and pantoprazole for gastroesophageal reflux disease (since Sep 2020).
On 18 Oct2020 (Day 81), the subject presented to the emergency room following an intubation prior to arrival after a cardiac arrest.  It was rep orted by the nursing facility 
that the subject did not have neurologic response other than occa sional movements and could breathe only with the help of ventilator settings.  Her electrocardiogram was 
abnormal, with initial rhythm of pulseless electrical activity and ischemic changes.  The downtime was reported as 15 minutes.  On the same day (Day 81), a computed 
tomogram of the head showed cerebral edema.  Emergency department personnel spoke with cardiology personnel, who deferred an intervention and a targeted temporal 
management (TTM) was ordered.  The laboratory results on 18 Oct2020 (Day 81) sh owed a blood chloride level of 124 mEq/L (normal range [NR]: 98 -111 mEq/L), blood 
glucose of 393 mg/dL (NR: 70- 99mg/dL), blood potassium of 3.5 mEq/L (NR: 3.6 -5.1mEq/L), blood sodium of 155 mEq/L (NR: 135 -145 mEq/L), carbon dioxide of 
18mmol/L (NR: 21 -31mmol/L), and glomerular filtration rate of 58 mL/min/1.73 m2 (NR: >59 mL/min/1.73 m2).  Pressors were required, and the subject was admitted to 
the intensive care unit.  On admission, the potassium level was low at 2.8 mEq/L.  On 19 Oct2020 (Day 82), th e subject was on TTM with high urine output overnight, 
which was concerning for diabetes insipidus.  On the same day (Day 82), the subject’s troponin I was high at 491 ng/L (NR: <15 ng/L), which was considered critical.  Her 
urine toxicology screening show ed elevated ethanol at 109 mg/dL (upper limit of normal: 9.9 mg/dL) and was positive for amphetamines.  The subject was an organ donor 
and her SARS -CoV -2 test was negative.  On 20 Oct2020 (Day 83), the subject was rewarmed and a magnetic resonance imaging showed anoxic brain injury with possible 
herniation, and an electroencephalogram showed absent brain activity.  On 21 Oct2020 (Day 84), the subject was pronounced dead at 1859 hours because of a cardiac arrest.  
It was unknown if an autopsy was performed .
In the opinion of the investigator, there was no reasonable possibility that the cardiac arrest was related to the study inte rvention, concomitant medications, or clinical trial 
procedures, as the death occurred 2 months after receiving Dose 2.  Pfizer c oncurred with the investigator’s causality assessment.
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016019
Compound: PF -07302048; Protocol: C4591001 Page 7of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1019 10191146; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 01SEP2020; Date of Last Dose: 22SEP2020
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PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1952 67 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
170.82 cm 116.18 kg 39.7 kg/m2 01SEP2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Myopia Myopia 1960 Present
Leg Cramps Muscle spasms 1972 Present
asthma Asthma 1985 Present
Allergic Rhinitis Rhinitis allergic 1986 Present
Hemorrhoids Haemorrhoids 1990 Present
Gastric Reflux Gastrooesophageal reflux disease 2000 Present
Hypercholesterolemia Hypercholesterolaemia 2002 Present
Recurrent Back pain Back pain 2010 Present
Osteoarthritis -knees Osteoarthritis 2010 Present
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FDA-CBER-2021-5683-1016020
Compound: PF -07302048; Protocol: C4591001 Page 8of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1019 10191146; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 01SEP2020; Date of Last Dose: 22SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Hypertension Hypertension 2016 Present
Atrial Fibrillation Atrial fibrillation 30OCT2019 Present
sleep apnea Sleep apnoea syndrome NOV2019 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 01SEP2020 (1) 14:40
2 Placebo 22SEP2020 (22) 07:56
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity 
Grade
1 NEOPL Biliary cancer metastatic Biliary Cancer Metastatic 27OCT2020 (57) 17DEC2020 (108) 52 4
2 NEOPL Metastases to liver Metastases to Liver 27OCT2020 (57) 17DEC2020 (108) 52 4
Adverse Events
AE 
NumberAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 W Y Fatal (17DEC2020) NOT RELATED/OTHER: Unknown 2 36 Y
2 W Y Fatal (17DEC2020) NOT RELATED/OTHER: metastatic biliary cancer 2 36 Y
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016021
Compound: PF -07302048; Protocol: C4591001 Page 9of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1019 10191146; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 01SEP2020; Date of Last Dose: 22SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nd a2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 01SEP2020
Completed VACCINATION 27OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 17DEC2020 DEATH
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016022
Compound: PF -07302048; Protocol: C4591001 Page 10of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1019 10191146; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 01SEP2020; Date of Last Dose: 22SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1019 10191146, a 67-year-old white male with a pertinent medical history of gastroesophageal reflux disease (since 2000), hypercholesterolemia 
(since 2002), hypertension (since 2016), and atrial fibrillation (since 30 Oct2019), received Dose 1 on 01 Sep2020 and Dose 2 on 22 Sep2020 (Day 22).  The subject was 
diagnosed with metastatic biliary cancer with metastases to the l iver on 27 Oct2020, 35 days after receiving Dose 2.  The subject was diagnosed with metastatic biliary 
cancer and metastases to the liver on 27 Oct2020, 35 days after receiving Dose 2, and died of the events on 17 Dec2020, 86 days after receiving Dose 2.
On 16 Oct2020 (Day 46), an ultrasound-guided core biopsy and liver biopsy revealed a poorly differentiated carcinoma in the liver, which led to a diagnosis of bili ary cancer 
with metastases to the liver on 27 Oct2020 (Day 57).  On 29 Oct2020 (Day 59),a positron emission tomography scan revealed no other organ involvement besides the liver.  
On 16 Nov 2020 (Day 77), the subject was scheduled for an oncology consultation (no further information reported).  The subject had no reported p redisposing factor s and 
died on 17 Dec2020 (Day 108) because of disease progression of biliary carcinoma metastatic to the liver.  No autopsy was performed.  
In the opinion of the investigator, there was no reasonable possibility that the metastatic biliary cancer with me tastases to the liver was related to the study intervention, 
concomitant medications, or clinical trial procedures.  Pfizer concurred with the investigator’s causality assessment.  
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016023
Compound: PF -07302048; Protocol: C4591001 Page 11of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1021 10211127; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 31AUG2020; Date of Last Dose: 23SEP2020
==========================================================================================================================
PFIZER CONFID ENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1966 54 Black or African American Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
178.2 cm 70.3 kg 22.1 kg/m2 31AUG2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Acid Reflux Gastrooesophageal reflux disease 2013 Present
Hypertension Hypertension 2013 Present
Bilateral Leg Edema Oedema peripheral 2013 Present
Congestive Heart Failure Cardiac failure congestive 2016 Present
Idiopathic Cardiomyopathy Cardiomyopathy 2016 Present
Irregular Heartbeat Heart rate irregular 2019 Present
Defibrillator Implant Implantable defibrillator insertion 2019 Past
Chronic Obstructive Pulmonary Disease Chronic obstructive pulmonary disease DEC2019 Present
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016024
Compound: PF -07302048; Protocol: C4591001 Page 12of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1021 10211127; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 31AUG2020; Date of Last Dose: 23SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, c m, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 31AUG2020 (1) 17:49
2 BNT162b2 23SEP2020 (24) 10:56
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity 
GradeAction 
to 
Subject
1 CARD Acute left ventricular 
failureNYHA Class IV Acute on 
Chronic Systolic Heart Failure19OCT2020 (50) 21OCT2020 (52) 3 3 TC
2 CARD Cardiac failure congestive Acute on Chronic Combined 
Systolic and Diastolic Congestive 
Heart Failure30NOV2020 (92) 19DEC2020 (111) 20 4 TC/W
3 METAB Hypokalaemia Hypokalemia 19OCT2020 (50) 21OCT2020 (52) 3 3 TC
Adverse Events
AE 
Number SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 Y Resolved (21OCT2020) NOT RELATED/OTHER: Not related to drug or non -drug treatments 2 27 Y
2 Y Fatal (19DEC2020) NOT RELATED/OTHER: Not related to drug or non- drug treatment 2 69 Y
3 N Resolved (21OCT2020) NOT RELATED/CONCOMITANT DRUG TREATMENT 2 27 N
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016025
Compound: PF -07302048; Protocol: C4591001 Page 13of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1021 10211127; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 31AUG2020; Date of Last Dose: 23SEP2020
======================================================================================================================== ==
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 31AUG2020
Completed VACCINATION 21OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 19DEC2020 DEATH
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016026
Compound: PF -07302048; Protocol: C4591001 Page 14of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1021 10211127; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 31AUG2020; Date of Last Dose: 23SEP2020
======================================================================================================================== ==
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1021 10211127, a 54-year-old black or African American male with a pertinent medical history of hypertension, peripheral edema (bilateral leg/foot 
edema), and gastroesophageal reflux disease (all since 2013); congestive cardiac failure and idiopathic cardiomyopathy (both since 2016); irregular heart rate (since 2019); 
defibrillator implant (in 2019); and chronic obstructive pulmonary disease (COPD; since Dec 2019), received Dose 1 on 31 Aug 2020 and Dose 2 on 23 Sep2020 (Day 24).  
The subject was diagnosed with acute left ventricular failure on 19 Oct2020 and congestive cardiac failure on 30 Nov 2020, 26 days and 68 days after receiving Dose 2, 
respectively.  He died of congestive heart failure on 19 Dec2020, 87 days after receiving Dose 2.
Concomitant medications include d acetylsalicylic acid (since 2013) for cardiac prophylaxis; cyanocobalamin, iron, folic acid, potassium chloride, and magnesium (all 
since 2013), all as supplements; pantoprazole (since 2013) for acid reflux; spironolactone (since 2013) for hypertension/b ilateral foot edema; torasemide (since 2013) for 
bilateral foot edema; salbutamol and olodaterol hydrochloride/tiotropium bromide monohydrate (both since Dec 2019), both for COPD; and nicotine (since 10Aug 2020) for 
smoking cessation. 
On 19 Oct2020 (Day 50), the subject presented to the emergency room (ER) with severe hypokalemia (potassium values not provided) and was diagnos ed with acute left 
ventricular failure (New York Heart Association Class 4 acute on chronic systolic heart failure), resulting in hospitalization.  Hypokalemia was considered likely to be 
secondary to the need for aggressive diuresis with torasemide 200 mg twice a day and metolazone 5 mg 3 times a week (unspecified start dates).  The subject’s magnesium 
and potassium levels were rest ored.  On 21 Oct2020 (Day 52), the acute left ventricular failure and hypokalemia resolved, and the subject was discharged from the hospital.  
On 30 Nov 2020 (Day 92), the subject’s ongoing history of peripheral edema worsened as a result of end -stage he art failure.  The subject went to the ER and was diagnosed 
with congestive cardiac failure that resulted in hospitalization.  A subsequent chest x -ray showed stable cardiac enlargement with a faint infiltrate and/or subsegmental 
atelectasis at the right lung base; however, there was no consolidation or edema observed.  The venous/lower -extremity Doppler performed on 04 Dec2020 (Day 96) showed 
no evidence of acute deep vein thrombosis.  A peripherally inserted central catheter line was placed for dobutamine infusion.  Per the cardiologist, the subject was only 
minimally responsive to aggressive medical therapy including intravenous (IV) diuretics and IV dobutamine because of idiopath ic cardiomyopathy and severe left ventricular 
systolic dysfunction coupled w ith acute on chronic combined systolic and diastolic heart failure.  Per the discharge summary, the subject was not a candida te for any 
advanced cardiac therapies.  On 06 Dec2020 (Day 98), the automatic implantable cardioverter defibrillator was turned of f.  On 08 Dec2020 (Day 100), influenza and SARS -
CoV -2 tests were negative.  On the same day (Day 100), the subject was discharged to an inpatient hospice care facility.  
On 19 Dec2020 (Day 111), the subject died of congestive cardiac failure (Stage IV) and disease progression.  No autopsy was performed.  
In the opinion of the investigator, there was no reasonable possibility that the acute left ventricular failure and congestiv e cardiac failure were related to the study 
intervention, concomitant medications, or clinical trial procedures.  Pfizer concurred with the investigator’s causality assessment.
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016027
Compound: PF -07302048; Protocol: C4591001 Page 15of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1027 10271191; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 11SEP2020; Date of Last Dose: 02OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1952 68 Black or African American Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
168.91 cm 62.45 kg 21.8 kg/m2 11SEP2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
allergy to cipro Drug hypersensitivity 1975 Present
thyroid cancer Thyroid cancer 1982 Past
thyroidectomy Thyroidectomy 1982 Past
dysmenorrhea Dysmenorrhoea 1990 Past
hysterectomy Hysterectomy 1990 Past
hyperlipidemia Hyperlipidaemia 2010 Present
hypertension Hypertension 2013 Present
irritable bowel syndrome (IBS) -constipation Irritable bowel syndrome 2014 Present
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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(b) (6)
FDA-CBER-2021-5683-1016028
Compound: PF -07302048; Protocol: C4591001 Page 16of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1027 10271191; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 11SEP2020; Date of Last Dose: 02OCT2020
=================================================================================================================== =======
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
emphysema Emphysema 2017 Present
lung cancer Lung neoplasm malignant 2017 Past
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 11SEP2020 (1) 12:59
2 Placebo 02OCT2020 (22) 09:20
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity 
Grade
1 RESP Acute respiratory failure Acute Hypoxic Respiratory 
Failure12JAN2021 (124) 13FEB2021 (156) 33 4
2 INFEC COVID -19 COVID -19 12JAN2021 (124) 13FEB2021 (156) 33 4
Adverse Events
AE 
NumberAction to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 TC/TCN/W Y Fatal (13FEB2021) NOT RELATED/OTHER: Diagnosis of COVID-19 2 103 Y
2 TC/TCN/W Y Fatal (13FEB2021) NOT RELATED/OTHER: Viral Infection 2 103 Y
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1027 10271191; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 11SEP2020; Date of Last Dose: 02OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 11SEP2020
Completed VACCINATION 02NOV2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 13FEB2021 DEATH
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FDA-CBER-2021-5683-1016030
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1027 10271191; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 11SEP2020; Date of Last Dose: 02OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1027 10271191, a 68-year-old black or African American female with a pertinent medical history of drug allergy to ciprofloxacin (since 1975),  thyroid 
cancer and thyroidectomy (both in 1982), hyperlipidemia (since 2010), hypertension (since 2013), emphysema (since 2017), and malignant lung neoplasm (in 2017), received 
Dose 1 on 11 Sep2020 and Dose 2 on 02 Oct2020 (Day 22).  The subject was diagnosed with acute respiratory failure and COVID -19 on 12 Jan2021, 102 days after 
receiving Dose 2, and died of the events on 13 Feb2021, 134 days a fter receiving Dose 2.
On 13 Jan2021 (Day 125), the subject completed a telehealth potential COVID-19 illness visit with a positive central laboratory COVID -19 test, and the subject’s local 
COVID -19 test from 14 Jan2021 (Day 126) was also positive.  The subject’s family informed the site that on 18 Jan2021 (Day 130), the subject presented to the hospital via 
emergency medical services with shortness of breath, productive cough, headache, fever, myalgia, lack of taste, decreased app etite, and 2 syncopal e pisodes.  According to 
the medical records, upon hospital admission, the subject was afebrile with a respiratory rate of 22 breaths/min.  The subject was noted to be hypoxic with blood saturation 
levels in the 80s (%), with improvement on supplemental oxyg en; her oxygen saturation was 95% on 3 L of supplemental oxygen via nasal cannula.  The subject was 
diagnosed with acute hypoxic respiratory failure due to COVID -19 with an onset date of 12 Jan2021 (Day 124).  She was treated with 6 mg of intravenous dexa methasone.  
The subject remained on oxygen therapy, and was additionally treated with albuterol inhalation, remdesivir, ascorbic acid, zi nc, and oral dexamethasone 6 mg daily.  On 
18Jan2021 (Day 130), the laboratory test results showed hemoglobin of 10.2 , potassium of 3.1, calcium of 8.1, C -reactive protein of 2.8, and fibrinogen of 530 (units and 
normal ranges [NRs] not available).  A computed tomography angiography of the chest with contrast revealed multifocal pneumon ia, left upper lobe and right hilar /suprahilar 
postradiation changes, and emphysema with no evidence of large or central pulmonary artery embolus.  On 20 Jan2021 (Day 132), the laboratory test results showed 
leukocytes of 10.6 K/µL (NR: 4.0 -10.5 K/µL) and neutrophils of 9.1 K/µL (NR: 1.7-7 .7 K/µL).  On 08 Feb2021 (Day 151), the subject was moved to hospice care because of 
deterioration in health from acute hypoxic respiratory failure caused by COVID -19.  On 15 Feb2021 (Day 158), the subject’s family informed the site that the subject had 
died on 13 Feb2021 (Day 156) because of acute hypoxic respiratory failure caused by COVID -19.  An autopsy was not performed.  The subject had COVID -19 illness per 
study protocol criteria.  
In the opinion of the investigator, there was no reasonable possi bility that the acute respiratory failure and COVID-19 were related to the study intervention, concomitant 
medications, or clinical trial procedures.  Pfizer concurred with the investigator’s causality assessment.
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1036 10361140; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 22OCT2020; Date of Last Dose: 12NOV2020
==========================================================================================================================
PFIZER CONFID ENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1956 64 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
187.96 cm 106.82 kg 30.2 kg/m2 22OCT2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
trouble sleeping Insomnia 1989 Present
back surgery Spinal operation 1990 Past
hypercholesterolemia Hypercholesterolaemia 1995 Present
hypertension Hypertension 1995 Present
back pain Back pain 1996 Present
Barrett's esophagus Barrett's oesophagus 1998 Present
urination frequency Pollakiuria 2005 Present
scoliosis of the spine Scoliosis 2010 Present
seasonal allergies Seasonal allergy 2010 Present
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FDA-CBER-2021-5683-1016032
Compound: PF -07302048; Protocol: C4591001 Page 20of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1036 10361140; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 22OCT2020; Date of Last Dose: 12NOV2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
osteoarthritis Osteoarthritis 2015 Present
ringing in the left ear; tinnitus Tinnitus 2015 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 22OCT2020 (1) 14:46
2 BNT162b2 12NOV2020 (22) 13:50
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity 
GradeAction 
to 
Subject
1 INJ&P Injury Traumatic Injuries 10FEB2021 (112) 10FEB2021 (112) 1 4 W
2 INJ&P Road traffic accident Motor Vehicle Accident 10FEB2021 (112) 10FEB2021 (112) 1 4 W
Adverse Events
AE 
Number SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 Y Fatal (10FEB2021) NOT RELATED/OTHER: car accident 2 91 Y
2 Y Fatal (10FEB2021) NOT RELATED/CONCOMITANT NON-DRUG TREATMENT 2 91 Y
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
Page 20
FDA-CBER-2021-5683-1016033
Compound: PF -07302048; Protocol: C4591001 Page 21of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1036 10361140; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 22OCT2020; Date of Last Dose: 12NOV2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, v s, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 22OCT2020
Completed VACCINATION 10DEC2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 10FEB2021 DEATH
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016034
Compound: PF -07302048; Protocol: C4591001 Page 22of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1036 10361140; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 22OCT2020; Date of Last Dose: 12NOV2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1036 10361140, a 64-year-old white male with a pertinent medical history of spinal operation (in 1990), scoliosis (since 2010), and osteoarthritis 
(since 2015), received Dose 1 on 22 Oct2020 and Dose 2 on 12 Nov 2020 (Day 22).  The subject died of traumatic injuries from a motor vehicle collision on 10 Feb 2021, 
90days after receiving Dose 2.  
On 10 Feb2021 (Day 112), the subject was involved in a motor vehicle accident resulting in death of the subject on impact from traumatic injurie s.  The subject was the 
driver.  No autopsy was performed.  
In the opinion of the investigator, there was no reasonable possibility that the traumatic injuries from the motor vehicle co llision were related to the study intervention or 
clinical trial proced ures.  Pfizer concurred with the investigator’s causality assessment.
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016035
Compound: PF -07302048; Protocol: C4591001 Page 23of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1039 10391010; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 21AUG2020; Date of Last Dose: 09SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1935 84 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
190.2 cm 88.88 kg 24.6 kg/m2 21AUG2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
allergic rhinitis Rhinitis allergic 1955 Present
high blood pressure Hypertension 1960 Present
hyperlipidemia Hyperlipidaemia 2000 Present
Hyperopia Hypermetropia 2000 Present
oseoarthritis, thumbs and fingers Osteoarthritis 2010 Present
torn left shoulder rotator cuff Rotator cuff syndrome 2010 Past
cataracts Cataract 2013 Past
carotid artery stenosis Carotid artery stenosis 2016 Present
coronary artery disease Coronary artery disease JUL2016 Present
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016036
Compound: PF -07302048; Protocol: C4591001 Page 24of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1039 10391010; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 21AUG2020; Date of Last Dose: 09SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, m h, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
hearing problems Auditory disorder 2020 Present
glasses wearer Corrective lens user 2020 Present
GERD Gastrooesophageal reflux disease 2020 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 21AUG2020 (1) 10:59
2 BNT162b2 09SEP2020 (20) 12:54
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity 
Grade
1 VASC Arteriosclerosis arthroscloratic cardiovascular 
disease18NOV2020 (90) 18NOV2020 (90) 1 4
2 CARD Hypertensive heart disease hypertensive cardiovascular 
disease18NOV2020 (90) 18NOV2020 (90) 1 4
3 GENRL Injection site pain INJECTION SITE PAIN 21AUG2020 (1) 19:00 23AUG2020 (3) 12:00 3 1
4 GENRL Injection site pain injection site pain 09SEP2020 (20) 19:00 11SEP2020 (22) 3 2
5 GENRL Pyrexia FEVER 10SEP2020 (21) 07:00 10SEP2020 (21) 19:00 1 1
6 INJ&P Contusion right arm bruising 21AUG2020 (1) 11:00 02SEP2020 (13) 11:00 13 1
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016037
Compound: PF -07302048; Protocol: C4591001 Page 25of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1039 10391010; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 21AUG2020; Date of Last Dose: 09SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Adverse Events
AE 
NumberAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 W Y Fatal (18NOV2020) NOT RELATED/OTHER: cardiovascular disease 2 71 Y
2 W Y Fatal (18NOV2020) NOT RELATED/OTHER: cardiovascular disease 2 71 Y
3 N N Resolved (23AUG2020) Study Treatment 1 1 N
4 N N Resolved (11SEP2020) Study Treatment 2 1 N
5 TC N Resolved (10SEP2020) Study Treatment 2 2 N
6 N N Resolved (02SEP2020) Study Treatment 1 1 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 21AUG2020
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016038
Compound: PF-07302048; Protocol: C4591001 Page 26of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1039 10391010; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 21AUG2020; Date of Last Dose: 09SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nd a2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed VACCINATION 08OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 18NOV2020 DEATH
Narrative Comment
Subject C4591001 1039 10391010, an 84 -year-old white male with a pertinent medical history of hypertension (since 1960), hyperlipidemia (since 2000), carotid artery 
stenosis (since 2016, stent placement in right carotid artery in 2016), coronary artery disease (since Jul 2016), and gastroesophageal reflux disease (since 2020), received 
Dose 1 on 21 Aug 2020 and Dose 2 on 09 Sep2020 (Day 20).  The subject died of arteriosclerosis and hypertensive heart disease on 18 Nov 2020, 70 days after receiving 
Dose 2.
Concomitant medications included acetylsalicylic acid (since 1990) for cardiac prophylaxis, multivitamin (since 1990) as a supplement, lovastatin (since 2014) for 
hyperlipidemia, Cernitin GBX, and Cernitin T60 (both since 2018), vitamin D (since 2019) as a supplement, and hydrochlorothia zide/olmesartan medoxomil (since 
10Sep2020) for hypertension.
The subject, with a hist ory of extensive cardiovascular disease, lost consciousness on 18 Nov 2020 (Day 90).  His family witnessed the event and attempted resuscitation, but 
it was unsuccessful.  The subject was not taken to the emergency room or physician’s office and he died on the same day (Day 90).  The subject had regular follow -ups with 
his primary care physician, and there were no new complications or events reported prior to the subject’s death.  The cause o f death was disease progression.  An autopsy was 
not performed.  
In the opinion of the investigator, there was no reasonable possibility that the arteriosclerosis and hypertensive heart dise ase were related to the study intervention, 
concomitant medications, or clinical trial procedures, but rather they were related to cardiovascular disease.  Pfizer concurred with the investigator’s causality assessment.
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016039
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1066 10661350; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 19OCT2020; Date of Last Dose: 19OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1962 58 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
182.88 cm 84.23 kg 25.1 kg/m2 19OCT2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
sulfa allergy Drug hypersensitivity 1980 Present
morphine allergy Drug hypersensitivity 1985 Present
anxiety Anxiety 1990 Present
GERD Gastrooesophageal reflux disease 2000 Present
hypertension Hypertension 2000 Present
insomnia Insomnia 2000 Present
L4-L5 laminotomy with diskectomy Spinal laminectomy 2012 Past
spinal stenosis Spinal stenosis 2012 Past
hyponatremia Hyponatraemia 2015 Present
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016040
Compound: PF -07302048; Protocol: C4591001 Page 28of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1066 10661350; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 19OCT2020; Date of Last Dose: 19OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, c m, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
history of seizure Seizure 2015 Past
history of alcohol abuse Alcohol abuse 2018 Past
cardiomyopathy Cardiomyopathy MAR2018 Present
myocardial infarction Myocardial infarction MAR2018 Past
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 19OCT2020 (1) 13:32
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)
1 CARD Myocardial infarction myocardial infarction 03NOV2020 (16) 03NOV2020 (16) 1
Adverse Events
AE 
NumberToxicity 
GradeAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 4 P/W Y Fatal (03NOV2020) NOT RELATED/OTHER: disease progression 1 16 Y
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016041
Compound: PF -07302048; Protocol: C4591001 Page 29of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1066 10661350; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 19OCT2020; Date of Last Dose: 19OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 19OCT2020
Withdrawn VACCINATION 03NOV2020 DEATH
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 03NOV2020 DEATH
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016042
Compound: PF -07302048; Protocol: C4591001 Page 30of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1066 10661350; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 19OCT2020; Date of Last Dose: 19OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1066 10661350, a 58-year-old white male with a pertinent medical history of hypertension (since 2000), gastroesophageal reflux disease (since 2000), 
insomnia (since 2000), alcohol abuse (from 2010 to 2018), hyponatremia (since 2015), seizures (in 2015), myocardial infarctio n (in Mar 2018), and cardiomyopathy (since 
Mar 2018; coronary angiography, left ventriculography, and left heart catheterization), received Dose 1 on 19 Oct2020.  The subject died of a myocardial infarction on 
03Nov 2020, 15 days after receiving Dose 1.
Concomitant medic ations included omeprazole (Protonix) (since 2015) for gastroesophageal reflux disease, trazodone (since 2015) for insomnia, Depade and acamprosate 
calcium (Campral) (since 2018), both for alcohol dependence, and levetiracetam (Keppra) (since 2018) for sei zures.  
The subject’s wife stated that the subject had suffered a heart attack and died in his sleep on 03 Nov 2020 (Day 16).  An autopsy was not performed.  
In the opinion of the investigator, there was no reasonable possibility that the myocardial infa rction was related to the study intervention, concomitant medications, or clinical 
trial procedures, but rather it was related to disease progression.  Pfizer concurred with the investigator’s causality asses sment.
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FDA-CBER-2021-5683-1016043
Compound: PF -07302048; Protocol: C4591001 Page 31of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1081 10811194; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 10SEP2020; Date of Last Dose: 29SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  S DTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1968 51 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
167.64 cm 95.82 kg 34 kg/m2 10SEP2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Hypothyroidism Hypothyroidism 1995 Present
Allergy to Sulfa drugs Drug hypersensitivity 2002 Present
Allergy to oral NSAIDs Drug hypersensitivity 2007 Present
Chronic obstructive pulmonary disease Chronic obstructive pulmonary disease 2015 Present
Hypertension Hypertension 2015 Present
Attention deficit disorder Attention deficit hyperactivity disorder 2017 Present
Osteoarthritis of the knees Osteoarthritis 2018 Present
Postmenopausal Postmenopause 2018 Present
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016044
Compound: PF -07302048; Protocol: C4591001 Page 32of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1081 10811194; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 10SEP2020; Date of Last Dose: 29SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 10SEP2020 (1) 12:44
2 Placebo 29SEP2020 (20) 13:39
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity 
Grade
1 CARD Myocardial infarction Myocardial Infarction 04NOV2020 (56) 04NOV2020 (56) 1 4
Adverse Events
AE 
NumberAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 W Y Fatal (04NOV2020) NOT RELATED/OTHER: Hypertensive cardiovascular disease 2 37 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1081 10811194; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 10SEP2020; Date of Last Dose: 29SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, v s, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 10SEP2020
Completed VACCINATION 27OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 04NOV2020 DEATH
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FDA-CBER-2021-5683-1016046
Compound: PF -07302048; Protocol: C4591001 Page 34of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1081 10811194; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 10SEP2020; Date of Last Dose: 29SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1081 10811194, a 51-year-old white female with a medical history of hypothyroidism (since 1995), drug hypersensitivity (allergy to sulfa drugs since 
2002 and allergy to oral nonsteroidal anti -inflammatory drugs [NSAIDs] since 2007), chronic obstructive pulmonary disease (COPD) and hypertens ion (both since 2015), 
attention deficit hyperactivity disorder (since 2017), and osteoarthritis and postmenopause (both since 2018), received Dose 1 on 10 Sep2020 and Dose 2 on 29 Sep 2020 
(Day 20).  The subject died of a myocardial infarction on 04 Nov 2020, 36 days after receiving Dose 2.
Concomitant medications included levothyroxine sodium (since 2015) for hypothyroidism; atomoxetine hydrochloride (since 2017) and bupropion hydrochloride (since 
2018) for attention deficit disorder; salbutamol sulfate (since 2018) for COPD; diclofenac (since 2018) for osteoarthritis; and hydrochlorothiazide/lisinopril (since 
01Aug 2020) for hypertension. 
The subject was scheduled for a visit on 11 Nov 2020 but did not show up for her appointment.  The family was conta cted, and they reported that the subject was found 
deceased in her home on 04 Nov 2020 and had likely died 3 days prior on 01 Nov 2020.  A family member had spoken with the subject on 01 Nov 2020 and the subject told 
her family member that she just got out of the shower and was going to go lie down because she had “stomach pains.”  This was the final conversation with the subject before 
she died.  No autopsy was performed.  The death certificate and toxicology report were received on 24 Nov 2020 and the dat e of death was 04 Nov 2020 per state 
regulations; the cause of death was reported as myocardial infarction due to hypertensive cardiovascular disease and disease progression.  It was reported that the toxicology 
report was negative.
In the opinion of the i nvestigator, there was no reasonable possibility that the myocardial infarction was related to the study intervention, concom itant medications, or clinical 
trial procedures, but rather it was related to hypertensive cardiovascular disease.  Pfizer concurre d with the investigator’s causality assessment.  
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FDA-CBER-2021-5683-1016047
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1084 10841266; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 22AUG2020; Date of Last Dose: 14SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1943 77 White Hispanic/Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
166.4 cm 79 kg 28.5 kg/m2 22AUG2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
environmental allergies Hypersensitivity 1975 Present
Type 2 Diabetes Type 2 diabetes mellitus 1980 Present
erectile dysfunction Erectile dysfunction 1985 Present
Levaquin allergy Drug hypersensitivity 2000 Present
Congestive Heart failure Cardiac failure congestive 2005 Present
CORONARY ARTERIAL BYPASS GRAFTS Coronary artery bypass 2005 Past
gangrene on all toes on right foot Gangrene 2011 Past
amputation of 5 toes on right foot Toe amputation 2011 Past
gangrene on left big toe Gangrene 2012 Past
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(b) (6)
FDA-CBER-2021-5683-1016048
Compound: PF -07302048; Protocol: C4591001 Page 36of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1084 10841266; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 22AUG2020; Date of Last Dose: 14SEP2020
========================================================================================================== ================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Hypercholesterolemia Hypercholesterolaemia 2012 Present
Amputation of left big toe Toe amputation 2012 Past
Bilateral Cataracts Cataract 2015 Past
Cataract Removal Cataract operation 2015 Past
gangrene on toe left foot Gangrene 2017 Past
Amputation of toe on left foot Toe amputation 2017 Past
Hypertension Hypertension 2018 Present
Ocular hypertension Ocular hypertension JUN2020 Present
atrophy to left hand Atrophy 22AUG2020 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 22AUG2020 (1) 13:51
2 BNT162b2 14SEP2020 (24) 11:26
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity
GradeAction to 
Subject
1 RENAL Acute kidney injury Acute Kidney Injury 03NOV2020 (74) ONGOING 2 TCN
2 CARD Atrial fibrillation Atrial Fibrillation with RVR 03NOV2020 (74) ONGOING 2 TC
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FDA-CBER-2021-5683-1016049
Compound: PF -07302048; Protocol: C4591001 Page 37of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1084 10841266; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 22AUG2020; Date of Last Dose: 14SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity
GradeAction to 
Subject
3 INFEC Emphysematous 
cholecystitisAcute Emphysematous 
Cholecystitis03NOV2020 (74) 12JAN2021 
(144)71 4 TC/TCN/W
4 MUSC Muscular weakness Left lower extremity weakness 28OCT2020 (68) ONGOING 2 N
5 MUSC Rhabdomyolysis Rhabdomolysis 02NOV2020 (73) 13NOV2020 (84) 12 2 TCN
6 INFEC Sepsis Sepsis 03NOV2020 (74) 12JAN2021 
(144)71 4 TC/TCN/W
Adverse Events
AE 
Number SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 N Yes NOT RELATED/OTHER: Dehydration 2 51 N
2 N Yes NOT RELATED/OTHER: CAD 2 51 N
3 Y Fatal (12JAN2021) NOT RELATED/OTHER: bacteria 2 51 Y
4 N Yes NOT RELATED/OTHER: sepsis 2 45 N
5 N Resolved 
(13NOV2020)NOT RELATED/OTHER: dehydration 2 50 N
6 Y Fatal (12JAN2021) NOT RELATED/OTHER: Klebsiella Oxytoca, Escherichia coli, 
Klebsiella pneumonia2 51 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
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FDA-CBER-2021-5683-1016050
Compound: PF -07302048; Protocol: C4591001 Page 38of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1084 10841266; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 22AUG2020; Date of Last Dose: 14SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Nonstudy Vaccines
Investigator Text WHO Drug Preferred Term Start Date
INFLUENZA VIRUS VACCINE 
QUADRIVALENT 240 MCG IMINFLUENZA VACCINE 08NOV2020
Pneumococcal Polysaccharide Vaccine 0.5mL IM PNEUMOCOCCAL VACCINE POLYSACCH 08NOV2020
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 22AUG2020
Completed VACCINATION 12OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 12JAN2021 DEATH
Narrative Comment
Subject C4591001 1084 10841266, a 77-year-old white male with apertinent medical history of type 2 diabetes mellitus (since 1980), erectile dysfunction (since 1985), drug 
hypersensitivity (Levaquin allergy, since 2000), congestive cardiac failure (since 2005; coronary artery bypass in 2005), gan grene and toe amputati on (all toes on right foot in 
2011, left big toe in 2012, and an unspecified left foot toe in 2017), hypercholesterolemia (since 2012), cataract s(bilateral; in 2015), hypertension (since 2018), ocular 
hypertension (since Jun 2020), and left hand atrophy ( since 22 Aug 2020), received Dose 1 on 22 Aug 2020 and Dose 2 on 14 Sep2020 (Day 24).  The subject was 
diagnosed with emphysematous cholecystitis and sepsis on 03 Nov 2020, 50 days after receiving Dose 2, and died of the events on 12 Jan2021, 120 days after receiving 
Dose 2.  
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FDA-CBER-2021-5683-1016051
Compound: PF -07302048; Protocol: C4591001 Page 39of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1084 10841266; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 22AUG2020; Date of Last Dose: 14SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Concomitant medications included metformin (since 1980) for type 2 diabetes mellitus; clopidogrel (since 2005) for congestive heart failure; atorvastatin (since 2012) for 
hypercholesterolemia; ubidecarenone (since 2012) and Curcuma longa rhizome (since 2018) as supplement; metoprolol (since 2018) for hypertension; chromium picolinate 
(since 2019) and magnesium (since 2020), both as supplement; latanoprost (since Jul2020 ) for glaucoma; insulin human injection/isophane and insulin hum an (since 
12Sep 2020), both for type 2 diabetes mellitus; and Aristotelia chilensis /Syzygium aromaticum bud (since Aug 2020) as supplement.
On 28 Oct2020 (Day 68), the subject experienced muscular weakness in the left lower extremity and was subsequently diagnosed with rhabdomyolysis on 02 Nov 2020 
(Day 73).  On 02 Nov 2020 (Day 73), the subject was admitted to the hospital with weakness in the left lower extremity after being bedbound for 4 days.  The subject could 
wiggle his toes but was unable to lift his left lower extremity.  The laboratory results on 02 Nov 2020 (Day 73) included a creatine kinase level of 2849 U/L (normal range 
[NR]: 39 -308 U/L), creatinine of 1.97 mg/dL (NR: 0.60 -1.30 mg/dL) , consistent with acute renal failure, brain natriuretic p eptide (BNP) of 403 pg/mL (NR: 0 -100 pg/mL), 
white blood cell (WBC) count of 16.3 × 103/mm3 (NR: 4.5- 10.5 ×103/mm3),andblood glucose of 379 and 342 (units and NR not reported), and the subject’s blood pressure 
(BP) measurements were 134/74 mmHg, 135/68 mmHg, 136/63 mmHg , and 134/77mmHg.  On 03 Nov 2020, the subject was hospitalized and the laboratory tests included 
troponin of 14.13 ng/mL (NR: 0.00 -0.04 ng/mL), consistent with a new non– ST-segment elevation myocardial infarction, and lactic acid of 2.8mmol/L (NR: 0.4 -
2.0mmol/L).  On 03 Nov 2020 (Day 74), the subject was diagnosed with sepsis, emphysematous cholecystitis, acute kidney injury, dehydration, and atrial fibrillation with 
rapid ventricular response.  A gallbladder drain was inserted for the acute emphysematous cholecystitis.  A blood culture on 03 Nov 2020 (Day 74) showed no aerobic or 
anaerobic growth for 5 days.  The subject’s BP ranged from 67/30 mmHg to 188/72 mmHg ,and the glucose values ranged from 134 to 346 (units and NR not repor ted).  
On 07 Nov 2020 (Day 78), the blood culture was reported positive for Klebsiella oxytoca, Escherichia coli , and Klebsiella pneumoniae .  On 07 Nov 2020 and 08 Nov 2020 
(Day 79), the subject’s BP was between 90/57 mmHg and 104/72 mmHg.  On 08 Nov 2020 (Day 79), the laboratory tests included blood glucose ranging from 213 to 280 
(units and NR not reported), creatinine of 1.63 mg/dL, creatine kinase of 92 U/L, BNP of 586 pg/mL, WBC count of 7.9 × 103/mm3, and troponin of 1.74 ng/mL.  On the 
same day (Day 79), the subject received influenza virus vaccine and the pneumococcal polysaccharide vaccine.  The subject’s BP fluctuated f rom 94/58 mmHg to 118/72 
mmHg from 11 Nov 2020 to 13 Nov 2020 (Days 82 to 84).  On 13 Nov 2020 (Day 84), repeat laboratory test re sults showed creatinine of 0.99 mg/dL, glucose of 134 and 
163, and WBC count of 6.33 ×103/mm3.  The subject was treated with sodium chloride, calcium gluconate, clopidogrel bisulfate, heparin sodium, docusate sodium, i nsulin 
human lispro, metoprolol tartr ate, paracetamol, glucose, dextrose/water, glucagon, ondansetron, potassium chloride, atorvastatin calcium, acetylsalicylic a cid, metformin, 
metronidazole, cefepime hydrochloride , and norepinephrine (all on 03 Nov 2020); lorazepam, iopamidol, magnesium oxi de, docusate sodium, and piperacillin 
sodium/tazobactam sodium (all from 03 Nov 2020 to 09 Nov 2020); and metronidazole/sodium chloride, levofloxacin, and albuterol/ipratropium (unspecified dates).  On 
13Nov 2020 (Day 84), the subject was discharged to a skilled nursing facility.  The rhabdomyolysis resolved on the same day.  The subject received levofloxacin, midodrine, 
and apixaban at the facility.  A SARS-CoV -2 polymerase chain reaction test on 13 Nov 2020 was negative during hospitalization.
On 12 Jan2021 (Day 144), the subject died of the emphysematous cholecystitis.  It was reported that the subject was on life support and the family requested that the subject 
be withdrawn from life support, as the subject’s condition was not getting better and the p hysician informed the family that there was no real hope for recovery.  It was 
unknown if an autopsy was performed ,and the reported cause of death was disease progression (acute emphysematous cholecystitis and sepsis).  The events atrial 
fibrillation, mus cular weakness, and acute kidney injury were ongoing at the time of the subject’s death.
In the opinion of the investigator, there was no reasonable possibility that the emphysematous cholecystitis and sepsis were related to the study intervention, concomi tant 
medications, or clinical trial procedures.  Pfizer concurred with the investigator’s causality assessment.
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1084 10841470; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 30SEP2020; Date of Last Dose: 21OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  S DTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1955 65 White Hispanic/Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
177.8 cm 130.4 kg 41.2 kg/m2 30SEP2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
gerd Gastrooesophageal reflux disease 2010 Present
hyperlipidemia Hyperlipidaemia 2010 Present
hypertension Hypertension 2010 Present
insomnia Insomnia 2010 Present
pulmonary fibrosis Pulmonary fibrosis 2014 Present
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FDA-CBER-2021-5683-1016053
Compound: PF -07302048; Protocol: C4591001 Page 41of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1084 10841470; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 30SEP2020; Date of Last Dose: 21OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nd a2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 30SEP2020 (1) 09:54
2 Placebo 21OCT2020 (22) 15:53
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)
1 INFEC COVID -19 COVID -19 Infection 31DEC2020 (93) 11JAN2021 (104) 12
2 GENRL Multiple organ dysfunction 
syndromeMutli -system organ failure 31DEC2020 (93) 11JAN2021 (104) 12
Adverse Events
AE 
NumberToxicity 
GradeAction to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 4 TC/TCN/W Y Fatal (11JAN2021) NOT RELATED/OTHER: COVID -19 2 72 Y
2 4 TC/TCN Y Fatal (11JAN2021) NOT RELATED/OTHER: COVID -19 2 72 Y
Prohibited Concomitant Medications
Investigator Text WHO Drug Preferred Term Start Date End Date Route
Monoclonal Antibodies MONOCLONAL ANTIBODIES 31DEC2020 31DEC2020
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FDA-CBER-2021-5683-1016054
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1084 10841470; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 30SEP2020; Date of Last Dose: 21OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Nonstudy Vaccines
Investigator Text WHO Drug Preferred Term Start Date
MODERNA COVID 19 VACCINE COVID -19 VACCINE MRNA (MRNA 1273) 23DEC2020
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 30SEP2020
Completed VACCINATION 18NOV2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 11JAN2021 DEATH
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FDA-CBER-2021-5683-1016055
Compound: PF -07302048; Protocol: C4591001 Page 43of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1084 10841470; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 30SEP2020; Date of Last Dose: 21OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM C reation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1084 10841470, a 65-year-old white male with a pertinent medical history of hyperlipidemia and hypertension (since 2010) and pulmonary fibrosis (since 
2014), received Dose 1 on 30 Sep2020 and Dose 2 on 21 Oct2020 (Day 22).  The subject was diagnosed with COVID -19 infection and multiple organ dysfunction 
syndrome on 31 Dec2020, 71 days after receiving Dose 2.  On 23 Dec2020 ( Day 85), the subject received a prohibited vaccination (Moderna COVID -19 vaccine [mRNA-
1273]) through his employer.  The site was first informed of this vaccination by the subject’s son on 07 Jan2021 (Day 100).
Concomitant medications included ezetimibe/simvastatin (since 2010) for hyperlipidemia, omeprazole (since 2013) for gastroesophageal reflux disease, nebivolol 
hydrochloride (since 2015) for hypertension, and trazodone (since 2015) for insomnia.
The subject experienced shortness of breath, fever, cou gh, fatigue, and muscle aches “a day or so after” exposure to COVID-19 on 28 Dec2020 (Day 90).  On 31 Dec2020 
(Day 93), the subject received monoclonal antibodies from his primary care physician.  Later the same day (Day 93), the subject pr esented to the emergency department with 
weakness, dyspnea, nausea, and diarrhea and was subsequently hospitalized with COVID -19.  On the same day (Day 93), the subject’s laboratory tests included: a positive 
SARS -CoV -2 test, sodium of 134 mmol/L (normal range [NR]: 137 -145 mmol/L), chloride of 97 mmol/L (NR: 98 -107 mmol/L), glucose of 121 mg/dL (NR: 74 -99mg/dL), 
aspartate aminotransferase of 78 (NR: 17 -59, unit not provided), alanine aminotransferase of 51 (normal high: 50, unit not provided), C-reactive protein of 191 .2mg/dL 
(normal high: 10 mg/dL), total protein of 8.5 g/dL (NR: 6.3 -8.2g/dL), D -dimer quantitative of 1.21 µg/mL fibrinogen equivalent units (normal high: 0.50 µg/mL), red blood 
cell count of 5.86 M/mm3 (NR: 4.20- 5.70 M/mm3), hemoglobin of 17.8 g/dL (NR: 13-17g/dL), and hematocrit of 53.1% (NR: 40% -50%).  The chest x-ray that same day 
(Day 93) was consistent with bilateral multifocal viral pneumonia.  The subject was treated with ondansetron hydrochloride, dexame thasone, sodium phosphate, enoxaparin 
sodium, nebivolol hydrochloride, magnesium sulfate, trazodone, acetaminophen, magnesium oxide, potassium bicarbonate/citric acid, potassium chloride, pantoprazole, 
loperamide, melatonin, and vitamin D3.  On 02 Jan2021 (Day 95), the subject was treated at beds ide for acute hypoxemic respiratory failure with a left radial arterial line 
placed, and he was intubated.  After being placed on a ventilator, his health status continued to deteriorate, resulting in m ultiple organ dysfunction syndrome.  On 
04Jan2021 (D ay97), he suffered acute renal failure.  Acute hypoxic respiratory failure and acute renal failure were considered because of t he COVID -19.  On 11 Jan2021 
(Day 104), the subject’s family opted for “do -not-resuscitate” status.  On 19 Jan2021 (Day 112), t he site learned that the subject had died on 11 Jan2021 (Day 104), and it 
was unknown if an autopsy was performed.  It was reported that the subject also experienced shock, nose bleeding, pulmonary f ibrosis, hypertension, acute kidney injury, 
dyslipidemia , and gastroesophageal reflux disease.  The cause of death was reported as disease progression, multiple organ dysfunction sy ndrome, and COVID -19 infection.  
The subject’s vaccine status was unblinded on 14 Jan2021.
In the opinion of the investigator, th ere was no reasonable possibility that the COVID-19 infection and multiple organ dysfunction syndrome were related to the study 
intervention, concomitant medications, or clinical trial procedures.  Multiple organ dysfunction syndrome was considered rela tedto COVID -19.  Pfizer concurred with the 
investigator’s causality assessment.
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1088 10881126; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 31AUG2020; Date of Last Dose: 23SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1954 65 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
187.9 cm 143.6 kg 40.7 kg/m2 31AUG2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Coronary Artery Disease (CAD) Coronary artery disease 1983 Present
hypercholesterolemia Hypercholesterolaemia 2010 Present
hypertension Hypertension 2010 Present
Obesity Obesity 2010 Present
heart burn -intermittent Dyspepsia 2012 Present
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1088 10881126; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 31AUG2020; Date of Last Dose: 23SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nd a2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 31AUG2020 (1) 14:28
2 Placebo 23SEP2020 (24) 08:48
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)
1 INFEC COVID -19 COVID -19 29NOV2020 (91) ONGOING
2 CARD Cardiac arrest cardiac arrest 01DEC2020 (93) 01DEC2020 (93) 1
3 CARD Coronary artery disease Coronary Artery Disease 01DEC2020 (93) 01DEC2020 (93) 16:00 1
Adverse Events
AE
NumberToxicity 
GradeAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 4 N Y Yes NOT RELATED/OTHER: COVID -19 2 68 Y
2 4 W Y Fatal (01DEC2020) NOT RELATED/OTHER: unknown 2 70 Y
3 4 N Y Resolved (01DEC2020) NOT RELATED/OTHER: cardiac arrest 2 70 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016058
Compound: PF -07302048; Protocol: C4591001 Page 46of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1088 10881126; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 31AUG2020; Date of Last Dose: 23SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, c m, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 31AUG2020
Completed VACCINATION 26OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 01DEC2020 DEATH
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016059
Compound: PF -07302048; Protocol: C4591001 Page 47of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1088 10881126; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 31AUG2020; Date of Last Dose: 23SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1088 10881126, a 65-year-old white male with a pertinent medical history of coronary artery disease (since 1983); hypercholesterolemia and hypertensio n 
(both since 2010); and dyspepsia (since 2012), received Dose 1 on 31 Aug 2020 and Dose 2 on 23 Sep2020 (Day 24).  The subject was diagnosed with COVID -19 on 
29Nov 2020, and cardiac arrest and coronary artery disease on 01 Dec2020, 67 days and 69 days after receiving Dose 2.  The subject died of cardiac arrest due to coronary 
artery diseas e and COVID -19 on 01 Dec2020, 69 days after receiving Dose 2.  
Concomitant medications included lisinopril (since 2010) for hypertension, atorvastatin (since 2010) for hypercholesterolemia, omeprazole (since 2010) for heartburn, 
apixaban (since 2015) for coronary artery disease, and folic acid (since 2015) as a nutritional supplement.  
The subject attended a COVID -19 illness visit on 30 Nov 2020 (Day 92) for cough first occurring on 29 Nov 2020 (Day 91), and a self-swab was performed, which had a 
positiv e result.  The local COVID-19 test on 01 Dec2020 (Day 93) was also positive.
The site was trying to contact the subject to unblind him for this study and, after an online search, it was discovered that the subject had died on 01 Dec2020 (Day 93).  On 
01Dec2020 (Day 93), the subject visited his primary care physician with cough, fatigue, muscle/body aches, diarrhea, nasal congestion, and a runny nose.  The subject was 
advised to self-isolate, increase fluids and rest, take acetaminophen as needed, and co nsider taking vitamin D and vitamin C to boost his immune system.  The subject was 
reported to have experienced cardiac arrest, and it was unknown if cardiopulmonary resuscitation was attempted.  The subject had cardiac arrest due to progression of 
coronar y artery disease, which led to death on the same day (Day 93).  The death certificate indicated the cause of death as cardiac arrest due to progression of coronary 
artery disease, hypertension, and COVID-19.  It was also reported that the coronary artery d isease and hypertension did not worsen after receiving study intervention.  An 
autopsy was not performed.
In the opinion of the investigator, there was no reasonable possibility that the cardiac arrest due to coronary artery diseas e and COVID -19 were related to the study 
intervention, concomitant medications, or clinical trial procedures.  Pfizer concurred with the investigator’s causality asse ssment.  
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016060
Compound: PF -07302048; Protocol: C4591001 Page 48of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1088 10881139; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 02SEP2020; Date of Last Dose: 15OCT2020
==========================================================================================================================
PFIZER CONFID ENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1938 82 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
189cm 104.6 kg 29.3 kg/m2 02SEP2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Benign prostatic hyperplasia (BPH) Benign prostatic hyperplasia 2012 Present
hypercholesterolemia Hypercholesterolaemia 2012 Present
Chronic obstructive pulmonary disease Chronic obstructive pulmonary disease 2015 Present
Coronary Artery Disease (CAD) Coronary artery disease 2015 Present
sleep apnea Sleep apnoea syndrome 2015 Present
vitamin D deficiency Vitamin D deficiency 2017 Present
constipation Constipation JUN2020 Present
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FDA-CBER-2021-5683-1016061
Compound: PF -07302048; Protocol: C4591001 Page 49of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1088 10881139; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 02SEP2020; Date of Last Dose: 15OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 02SEP2020 (1) 16:10
2 BNT162b2 15OCT2020 (44) 14:05
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity 
Grade
1 NEOPL Metastases to lung Metastases to the lungs 24FEB2021 (176) 06MAR2021 (186) 11 4
2 NEOPL Pancreatic carcinoma 
metastaticMetastatic pancreatic cancer 24FEB2021 (176) ONGOING 4
Adverse Events
AE 
NumberAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 W Y Fatal (06MAR2021) NOT RELATED/OTHER: Metastases to the lungs 2 133 Y
2 N Y Yes NOT RELATED/OTHER: Pancreatic Cancer 2 133 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016062
Compound: PF -07302048; Protocol: C4591001 Page 50of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1088 10881139; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 02SEP2020; Date of Last Dose: 15OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Nonstudy Vaccines
Investigator Text WHO Drug Preferred Term Start Date
PNEUMONIA VACCINE PNEUMOCOCCAL VACCINE 16SEP2020
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 02SEP2020
Completed VACCINATION 11NOV2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 06MAR2021 DEATH
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016063
Compound: PF-07302048; Protocol: C4591001 Page 51of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1088 10881139; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 02SEP2020; Date of Last Dose: 15OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nd a2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1088 10881139, an 82-year-old white male with a pertinent medical history of hypercholesterolemia (since 2012); myocardial infarction with stent 
placement (in 2015); and coronary artery disease, chronic obstructive pulmonary disease (COPD), and sleep apnea syndrome (all since 2015), received Dose 1 on 
02Sep2020 and Dose 2 on 15 Oct2020 (Day 44).  The subject was diagnosed with metastatic pancreatic cancer and metastasis to the lungs on 24 Feb2021, 132 days after 
receiving Dose 2.  The subject died because of metastasis t o the lungs on 06 Mar 2021, 142 days after receiving Dose 2.
Concomitant medications included simvastatin (since 2012) for hypercholesterolemia; terazosin (since 2012) for benign prostat ic hyperplasia; budesonide/formoterol 
fumarate, tiotropium bromide, an d salbutamol (all since 2015) for COPD; nitroglycerin (since 2015) for chest pain; acetylsalicylic acid (since 2015) for card iovascular 
prophylaxis; colecalciferol (since 2017) for vitamin deficiency; and docusate and Plantago ovata (both since Jun 2020) f or constipation.  
On 28 Feb2021 (Day 180), the subject was hospitalized because of pancreatic cancer with metastasis to the lungs.  The site was not aware of any preexisting neoplasm.  No 
disease -specific treatment was reported.  The subject was discharg ed from the hospital on 05 Mar 2021 (Day 185).  On 06 Mar 2021 (Day 186), the subject died at home 
because of metastasis to the lungs and disease progression.  No autopsy was performed.  
In the opinion of the investigator, there was no reasonable possibil ity that the metastatic pancreatic cancer and metastasis to the lungs were related to the study intervention, 
concomitant medications, or clinical trial procedures.  Pfizer concurred with the investigator’s causality assessment.  
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016064
Compound: PF -07302048; Protocol: C4591001 Page 52of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1089 10891073; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 06AUG2020; Date of Last Dose: 04SEP2020
======================================================================================================================== ==
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1957 63 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
167.64 cm 112.91 kg 40.1 kg/m2 06AUG2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
sulfa drug allergy Drug hypersensitivity 1966 Present
GERD Gastrooesophageal reflux disease 1983 Present
cervical cancer Cervix carcinoma 1991 Past
demoral drug allergy Drug hypersensitivity 1991 Present
hysterectomy Hysterectomy 1991 Past
COPD Chronic obstructive pulmonary disease 1999 Present
myocardial infarction Myocardial infarction 2003 Past
right ankle broken Ankle fracture 2005 Past
right ankle rods placed Ankle operation 2005 Past
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016065
Compound: PF -07302048; Protocol: C4591001 Page 53of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1089 10891073; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 06AUG2020; Date of Last Dose: 04SEP2020
==========================================================================================================================
PFIZER CONFID ENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
elevated cholesterol Blood cholesterol increased 2005 Present
hypertension Hypertension 2005 Present
myocardial infarction Myocardial infarction 2005 Past
edema bilateral legs Oedema peripheral 2005 Present
osteoarthritis Osteoarthritis 2005 Present
insomnia Insomnia 2008 Present
prilosec drug allergy Drug hypersensitivity SEP2008 Present
anxiety Anxiety 2009 Present
depression Depression 2009 Present
irritable bowel syndrome diarrhea Irritable bowel syndrome 2011 Present
seasonal allergies Seasonal allergy 2012 Present
diabetic neuropathy Diabetic neuropathy 2013 Present
diabetes type 2 Type 2 diabetes mellitus 2013 Present
chronic back pain Back pain 2014 Present
penicillin drug allergy Drug hypersensitivity 2018 Present
clindamycin drug allergy Drug hypersensitivity 2018 Present
lower lumbar back surgery Spinal operation 2018 Past
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 06AUG2020 (1) 12:27
2 BNT162b2 04SEP2020 (30) 15:28
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FDA-CBER-2021-5683-1016066
Compound: PF -07302048; Protocol: C4591001 Page 54of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1089 10891073; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 06AUG2020; Date of Last Dose: 04SEP2020
========================================================================================================== ================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)
1 RESP Chronic obstructive 
pulmonary diseaseWorsening of COPD 12NOV2020 (99) 12NOV2020 (99) 1
Adverse Events
AE 
NumberToxicity 
GradeAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 4 W Y Fatal (12NOV2020) NOT RELATED/OTHER: history of COPD 2 70 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016067
Compound: PF-07302048; Protocol: C4591001 Page 55of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1089 10891073; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 06AUG2020; Date of Last Dose: 04SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nd a2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 06AUG2020
Completed VACCINATION 02OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 12NOV2020 DEATH
Narrative Comment
Subject C4591001 1089 10891073, a 63-year-old white female with a pertinent medical history of drug hypersensitivity (sulfa allergy; since 1966), tobacco use (since 19 75), 
gastroesophageal reflux disease (GERD; since 1983), cervix carcinoma (in 1991), drug hypersensitivity (Demerol drug allergy; since 1991), chronic obstructive pulmonary 
disease (COPD; since 1999), myocardial infarction (in 2003 and 2005), ankle fracture (in 2005), hypertension, blood cholester ol increased, osteoarthritis, and peripheral 
edema (all since 2005), insomnia (since 2008), drug hypersensitivity (Prilosec drug allergy; since Sep 2008), anxiety and depression (both since 2009), irritable bowel 
syndrome (since 2011), seasonal allergy (since 2012), type 2 diabetes mellitus and diabetic neuropathy (both since 2013), back pain (since 2014), and drug hypersensitivity 
(clindamycin drug allergy and penicillin drug allergy; since 2018), received Dose 1 on 06 Aug 2020 and Dose 2 on 04 Sep2020 (Day 30).  The subject died of worsening of 
COPD on 12 Nov 2020, 69 days after receiving Dose 2.  
Concomitant medications included acetylsalicylic acid (since 2005) for cardiac prophylaxis, salbutamol (since 2006) for COPD, ranitidine (since 2008) for GERD, 
furosemide (since 2010) for edema, metformin ( since 2010) for type 2 diabetes mellitus, hydralazine hydrochloride (since 2011) for hypertension, spironolactone (since 
2019) for edema, paroxetine hydrochloride and lamotrigine (both since 2019) for depression, and aripiprazole (since 2019) for anxiety. 
The subject had known but stable chronic lung disease at enrollment.  On 01 Dec2020 (Day 118), the subject's sister-in -law informed the site that the subject had died on 
12Nov 2020 (Day 99) because of worsening of COPD.  Relevant tests were unknown.  S he died under hospice care at home.  An autopsy was not performed. 
In the opinion of the investigator, there was no reasonable possibility that the worsening of COPD was related to the study i ntervention, concomitant medications, or clinical 
trial procedu res.  Pfizer concurred with the investigator’s causality assessment.
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FDA-CBER-2021-5683-1016068
Compound: PF -07302048; Protocol: C4591001 Page 56of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1089 10891088; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 07AUG2020; Date of Last Dose: 28AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1938 82 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
165.1 cm 60 kg 22 kg/m2 07AUG2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
seasonal allergies Seasonal allergy 1950 Present
GERD Gastrooesophageal reflux disease 1970 Present
hysterectomy Hysterectomy 1980 Past
osteoarthritis Osteoarthritis 1995 Present
depression Depression 2000 Present
muscle spasms Muscle spasms 2000 Present
herpes labialis Oral herpes 2000 Present
L3 back surgery Spinal operation 2007 Past
L4 back surgery Spinal operation 2008 Past
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016069
Compound: PF -07302048; Protocol: C4591001 Page 57of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1089 10891088; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 07AUG2020; Date of Last Dose: 28AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
chronic diarrhea Diarrhoea 2010 Present
insomnia Insomnia 2010 Present
vertigo Vertigo 2010 Present
chronic cough Cough 2016 Present
nausea Nausea 2018 Present
peripheral neuropathy Neuropathy peripheral 2018 Present
tremors Tremor 2019 Present
dementia of Alzheimer's Dementia Alzheimer's type NOV2019 Present
anemia Anaemia JAN2020 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 07AUG2020 (1) 16:07
2 Placebo 28AUG2020 (22) 12:34
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)
1 NERV Dementia Alzheimer's type Worsening of Dementia 
(Alzheimer's).20DEC2020 (136) 30DEC2020 (146) 11
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FDA-CBER-2021-5683-1016070
Compound: PF -07302048; Protocol: C4591001 Page 58of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1089 10891088; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 07AUG2020; Date of Last Dose: 28AUG2020
================================================================================================ ==========================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Adverse Events
AE 
NumberToxicity 
GradeAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 4 W Y Fatal (30DEC2020) NOT RELATED/OTHER: Dementia 2 115 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 07AUG2020
Completed VACCINATION 28SEP2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 30DEC2020 DEATH
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016071
Compound: PF -07302048; Protocol: C4591001 Page 59of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1089 10891088; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 07AUG2020; Date of Last Dose: 28AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM C reation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1089 10891088, an 82 -year-old white female with a pertinent medical history of depression and muscle spasms (both since 2000); diarrhea, insomnia, and 
vertigo (all since 2010); nausea and peripheral neuropathy (both since 2018); tremor (si nce 2019); dementia Alzheimer’s type (since Nov 2019); and anemia (since 
Jan2020), received Dose 1 on 07 Aug 2020 and Dose 2 on 28 Aug 2020 (Day 22).  The subject was diagnosed with worsening of dementia (Alzheimer’s) on 20 Dec2020, 
114days after receiv ing Dose 2, and died of the event on 30 Dec2020, 124 days after receiving Dose 2.  
According to the subject’s spouse, the subject stopped eating and drinking on 20 Dec2020 (Day 136).  All concomitant medications were discontinued from 20 Dec2020 
(Day 136) onward.  On 30 Dec2020 (Day 146), the subject died at home and the cause of death was the worsening of dementia (Alzheimer’s).  The subject had no sympto ms 
of COVID -19 at the time of the death.  An autopsy was not performed.  
In the opinion of the in vestigator, there was no reasonable possibility that the worsening of dementia (Alzheimer’s) was related to the study interve ntion, concomitant 
medications, or clinical trial procedures.  Pfizer concurred with the investigator’s causality assessment.  
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016072
Compound: PF -07302048; Protocol: C4591001 Page 60of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1094 10941112; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 08SEP2020; Date of Last Dose: 29SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1963 57 White Hispanic/Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
152.4 cm 79.5 kg 34.2 kg/m2 08SEP2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Cholecystectomy Cholecystectomy 1990 Past
Hysterectomy Hysterectomy 1995 Past
Diabetes Type II Type 2 diabetes mellitus 1995 Present
Asthma Asthma 2005 Present
Hypothyroid Hypothyroidism 2005 Present
Hypercholesterolemia Hypercholesterolaemia 2010 Present
Depression Depression 26MAY2020 Present
GERD Gastrooesophageal reflux disease 26MAY2020 Present
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1094 10941112; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 08SEP2020; Date of Last Dose: 29SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 08SEP2020 (1) 14:59
2 Placebo 29SEP2020 (22) 14:25
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity 
Grade
1 RESP Acute respiratory failure Acute hypoxemic respiratory 
failure28NOV2020 (82) 18DEC2020 (102) 21 4
2 INFEC COVID -19 COVID -19 Infection 26NOV2020 (80) 18DEC2020 (102) 23 4
3 INFEC Pneumonia Pneumonia 26NOV2020 (80) 18DEC2020 (102) 23 4
Adverse Events
AE 
NumberAction to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 TC/TCN/W Y Fatal (18DEC2020) NOT RELATED/OTHER: COVID -19 Pneumonia 2 61 Y
2 TC Y Fatal (18DEC2020) NOT RELATED/OTHER: COVID -19 2 59 Y
3 TC/TCN Y Fatal (18DEC2020) NOT RELATED/OTHER: COVID -19 Infection 2 59 Y
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1094 10941112; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 08SEP2020; Date of Last Dose: 29SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 08SEP2020
Completed VACCINATION 28OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 18DEC2020 DEATH
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016075
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1094 10941112; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 08SEP2020; Date of Last Dose: 29SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, c m, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1094 10941112, a 57-year-old white female with a pertinent medical history of type 2 diabetes mellitus (since 1995); hypothyroidism and asthma (both 
since 2005); hypercholesterolemia (since 2010); vitamin D deficiency (since Jan 2020); and insomnia and sleep apnea (both since May 2020), received Dose 1 on 
08Sep2020 and Dose 2 on 29 Sep2020 (Day 22).  The subject developed COVID-19 infection and pneumonia on 26 Nov 2020, 58 days after receiving Dose 2; and acute 
hypoxemic respiratory failure on 28 Nov 2020, 60 days after receiving Dose 2.  The subject died of the COVID-19 infection, pneumonia, and acute hypoxemic respiratory 
failure on 18 Dec2020, 80 days after receiving Dose 2.
On 26 Nov 2020 (Day 80), the subject experienced acute shortness of breath, and her family called emergency medical services.  On arrival, the su bject complained of 
respiratory symptoms, which she had been experiencing for the past 3 to 4 days.  She stated that since the start of her respiratory symptoms, her oxygen levels declined ; she 
had intermittent fevers, diffuse body aches, and left -sided abdominal pain.  In the emergency room, her oxygen saturation was 82% on room air, which improved with 4 L of 
oxygen via nasal cannula.  On the same day (Day 80), the subject underwent laboratory tests and procedures, which showed blood urea nitrogen (BUN) at 16 mg/dL (normal 
range [NR]: 7 -22mg/dL), creatinine at 0.76 mg/dL (NR: 0.50 -1.40 mg/dL), white blood cell (WBC) count at 9.2 K/cmm (NR: 3.7 -10.4 K/cmm), hemoglobin (Hgb) at 
12.5 g/dL (NR: 12.0 -16.0 g/dL), hematocrit (Hct) at 36.6% (NR: 36.0% -48.0%), platelet count at 272 K/cmm (NR: 133 -450 K/cmm), and troponin less than 0.02 ng/mL 
(NR: 0.00 -0.40 ng/mL); a SARS -CoV -2  nucleic acid amplification test was positive; an electrocardiogram (ECG) showed sinus rhythm but could not rule out anteri or 
infection; chest x -ray showed bilateral pneumonia; computerized tomogram of abdomen with pelvis showed extensive ground-glass pulmonary opacities in the lungs 
consistent with the given history of COVID -19 infection.  On the same day (Day 80), the subject was admitted to the intensive care unit.
On 28 Nov 2020 (Day 82), the subject developed acute hypoxemic respiratory failure.  On 29 Nov 2020 (Day 83), troponin was less than 0.02 ng/mL, ECG showed sinus 
bradycardia, and D -dimer was 0.64 µg/mL (NR not provided).  On 30 Nov 2020 (Day 84), a chest x -ray showed severe viral pneumonia.  On 01 Dec2020 (Day 85), a chest 
x-ray showed mildly improved opacities in the lower lobes, with no definite pneumothorax.  On 02 Dec2020 (Day 86), a chest x -ray showed resolution of the right 
pneumothorax and decrease in size of the trace left apical pne umothorax.  On 05 Dec2020 (Day 89), creatine kinase MB was high at 9.3 ng/mL (NR: 0.5- 3.6ng/mL) and 
troponin was less than 0.02 ng/mL.  On 09 Dec2020 (Day 93), oxygen saturation was 98.4% (NR: 95.0% -100.0%).  On 12 Dec2020 (Day 96), oxygen saturation w as 93.5% 
and on 13 Dec2020 (Day 97), the WBC count was 18.0 K/cmm, Hgb was 8.8 g/dL, Hct was 28.7%, and platelet count was 177 K/cmm.  On 14 Dec2020 (Day 98), 
creatinine was 2.43 mg/dL, BUN was 73 mg/dL, WBC count was 13.6 K/cmm, Hgb was 8.4 g/dL, Hct wa s 26.7%, and platelet count was 163 K/cmm.  On 15 Dec2020 
(Day 99), creatinine was 3.72 mg/dL and BUN was 97 mg/dL.  On 16 Dec2020 (Day 100), oxygen saturation was 83.3%, WBC count was 10.3 K/cmm, Hgb was 7.2 g/dL, 
Hct was 22.6%, platelet count was 151 K/cmm, creatinine was 4.61 mg/dL, and BUN was 109 mg/dL.  SARS -CoV -2 tests were positive on 10 Dec2020 (Day 94) and 
17Dec2020 (Day 101) during hospitalization.  During the course of hospitalization, the subject was treated with remdesivir, benzonatate, d examethasone, steroids, 
convalescent plasma, mechanically assisted ventilation, zinc sulfate, and vitamin C.  The subject had a long course with COVI D-19; her condition did not improve and she 
was compassionately extubated.  On 21 Dec2020 (Day 105), the s ubject's daughter informed the site of her mother's untimely death, which occurred on 18 Dec2020 
(Day 102).  An autopsy was not performed, and the cause of death was reported as COVID -19, pneumonia, and acute hypoxemic respiratory failure.  
In the opinio n of the investigator, there was no reasonable possibility that the COVID -19 infection, pneumonia, and acute hypoxemic respiratory failure were related to the 
study intervention or clinical trial procedures.  Pfizer concurred with the investigator’s causal ity assessment.
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1097 10971023; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 24AUG2020; Date of Last Dose: 15SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1933 86 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
157.48 cm 72.73 kg 29.3 kg/m2 24AUG2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Essential Hypertension Essential hypertension 03JUN2018 Present
GERD Gastrooesophageal reflux disease 03JUN2018 Present
Osteoarthritis Osteoarthritis 04JUN2018 Present
Allergic Rhinitis Rhinitis allergic 04JUN2018 Present
Abnormal Blood Glucose Blood glucose abnormal 13JAN2020 Present
Hyperlipidemia Hyperlipidaemia 01JUN2020 Present
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Compound: PF -07302048; Protocol: C4591001 Page 65of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1097 10971023; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 24AUG2020; Date of Last Dose: 15SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 24AUG2020 (1) 10:30
2 BNT162b2 15SEP2020 (23) 11:48
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity 
Grade
1 INFEC Septic shock Septic Shock 16DEC2020 (115) 21:51 21DEC2020 (120) 12:08 6 4
Adverse Events
AE 
NumberAction to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 TC/TCN/W Y Fatal (21DEC2020) NOT RELATED/OTHER: Gallbladder Failure 2 93 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016078
Compound: PF -07302048; Protocol: C4591001 Page 66of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1097 10971023; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 24AUG2020; Date of Last Dose: 15SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 24AUG2020
Completed VACCINATION 15OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 21DEC2020 DEATH
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016079
Compound: PF -07302048; Protocol: C4591001 Page 67of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1097 10971023; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 24AUG2020; Date of Last Dose: 15SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1097 10971023, an 86-year-old white female with a pertinent medical history of essential hypertension (since 03 Jun2018), hyperlipidemia (since 
01Jun2020), and abnormal blood glucose (since 13 Jan2020), received Dose 1 on 24 Aug 2020 and Dose 2 on 15 Sep2020 (Day 23). The subject developed septic shock 
on 16 Dec2020, 92 days after receiving Dose 2, and died of the septic shock on 21 Dec2020, 97 days after receiving Dose 2.
Concomitant medications included ciclosporin (since 07 Jun2020) for dry eyes, conjugated estro gens (since 14 Jul2020) for health maintenance, 
hydrochlorothiazide/losartan potassium (since 25 Jul2020) for essential hypertension, meloxicam (since 25 Jul2020) for osteoarthritis, metoprolol tartrate (since 
24Aug 2020) for essential hypertension, and mirabegron (since 24 Aug 2020) for urinary incontinence. 
On 16 Dec2020 (Day 115), the subject had 4 episodes of emesis.  On 17 Dec2020 (Day 116), the subject had 2 episodes of emesis and came to the emergency room, with 
abdominal pain in the lower qua drant along with nausea.  She described the pain as throbbing and aching, which was localized in her lower abdominal area wit h tenderness in 
the right upper quadrant.  The subject denied fever, chills, bloody emesis, bloody stool, or rectal pain, and she w as hospitalized for care.  The subject received a nasogastric 
tube and a dose of magnesium citrate.  On 17 Dec2020 (Day 116), a chest x -ray was unremarkable, computed tomography (CT) of the abdomen showed acute mild small -
bowel obstruction due to formed stool, heterogeneously enhanced solid left renal mass, and colonic diverticulitis, and an ultrasound examination of the biliar y duct on the 
same day confirmed cholelithiasis.  On the same day (Day 116), laboratory tests showed high levels of lactic acid: 2. 4 mmol/L (normal range [NR]: 0.7- 1.9mmol/L) and 
creatinine: 1.4 mg/dL (NR: 0.52 -1.04 mg/dL).  Emergency surgery was required because of abdominal pain with acidosis and suspected acute renal failure.  During su rgery, 
it was found that the subject had darky bloody fluid in the abdomen and a distended inflamed pregangrenous gallbladder, with a twisted loop of small bowel in the p elvis that 
could not be released.  It was decided to remove the gallbladder after emptying it.  On the same day (Day 116), postoperatively, the subject was transferred to the intensive 
care unit (ICU) and intubated.  She was diagnosed with septic shock and was treated with Levophed, vasopressin, Neosynephrine , and intravenous (IV) hydrocortisone 
sodium succinate.  
On 19 Dec2020 (Day 118), the subject’s chest x -ray showed bibasilar atelectasis with mild edema and/or infiltrates, and a CT scan of the abdomen showed a small -bowel 
obstruction and distended gallbladder with gallstones.  On the same day (Day 118), the subject’s creatinine was high at 3.13 mg/dL.  On 20 Dec2020 (Day 119), the 
subject’s chest x -ray showed development of subcutaneous emphysema, and abdominal x -ray showed paucity of bowel gas.  While the subject was in the hospital, her 
condition continued to decline; she was tachycardic, hypotensive, and in atrial fibrillation with rapid ventricular response and also developed severe metabolic acid osis.  
During the hospitalization, the subject was treated with acetaminophen rectal suppository 650 mg as needed (PRN); zolpidem t artrate 10 mg (2 tablets) PRN; acetylsalicylic 
acid 300 mg rectal suppository once per day (QD); diltiazem 20 mg IV once; diltiazem 25 mg IV once; magnesium hydroxide 30 mL orally (PO) PRN; norepinephrine 4 mg 
+ dextrose QD; oxycodone hydrochloride/paracet amol (5/325) 2 tablets PO PRN; omeprazole 40 mg IV QD; paracetamol 650 mg (2 tablets) PRN; piperacillin 
sodium/tazobactam sodium (dose not provided); fluconazole 200 mg IV QD; diltiazem 100 mg IV + sodium chloride QD; metronidazole 500 mg IV every 8 hours; labetalol 
10mg IV every 6 hours (Q6H); metoprolol 5 mg IV Q6H; morphine 4 mg IV every 4 hours; normal saline flush 10 mL PRN; promethazine 25 mg IV Q6H; ketorolac 
tromethamine 15 mg IV PRN; and ondansetron 4 mg IV PRN.  Even after the treatment, the subject’s condition declined and her family decided to withdraw care, and the 
subject was extubated.  On 20 Dec 2020 (Day 119), the subject’s creatinine was high at 4.31 mg/dL, blood lactic acid was high at 9.4 mmol/L, and the glomerular filtration 
rate was 8 mL/min/1.73 m2 (NR not reported).  On 21 Dec2020 (Day 120), at 12:08 am, the subject died of septic shock.  An autopsy was not performed.  There was no 
indication in the hospital records that the subject had a COVID -19 test.  
In the opinion of the invest igator, there was no reasonable possibility that the septic shock was related to the study intervention, concomitant medicati ons, or clinical trial 
procedures.  Pfizer concurred with the investigator’s causality assessment.
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1114 11141050; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 18AUG2020; Date of Last Dose: 08SEP2020
==========================================================================================================================
PFIZER CONFI DENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1956 63 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
165 cm 74.1 kg 27.2 kg/m2 18AUG2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Presbyopia Presbyopia 01JAN1973 Present
Depression Depression 01JAN1984 Present
Hearing Loss Deafness 01JAN1991 Present
Postmenopausal Postmenopause 01JAN2000 Present
Degenerative Disc Disease Intervertebral disc degeneration 18AUG2005 Present
Hypertension Hypertension 01JAN2010 Present
Osteoporosis Generalized Osteoporosis 01JAN2010 Present
Rheumatoid Arthritis -Generalized Rheumatoid arthritis 01JAN2010 Present
Sleep Apnea Sleep apnoea syndrome 01JAN2016 Present
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FDA-CBER-2021-5683-1016081
Compound: PF -07302048; Protocol: C4591001 Page 69of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1114 11141050; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 18AUG2020; Date of Last Dose: 08SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Right Rotator Cuff Tear Rotator cuff syndrome 01JUL2016 Past
Right Rotator Cuff Repair Rotator cuff repair 01AUG2016 Past
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 18AUG2020 (1) 15:53
2 BNT162b2 08SEP2020 (22) 15:45
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)
1 GENRL Sudden cardiac death Sudden cardiac death 19OCT2020 (63) 19OCT2020 (63) 1
Adverse Events
AE 
NumberToxicity 
GradeAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 4 W Y Fatal (19OCT2020) NOT RELATED/OTHER: unknown 2 42 Y
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FDA-CBER-2021-5683-1016082
Compound: PF -07302048; Protocol: C4591001 Page 70of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1114 11141050; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 18AUG2020; Date of Last Dose: 08SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 18AUG2020
Completed VACCINATION 07OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 19OCT2020 DEATH
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016083
Compound: PF -07302048; Protocol: C4591001 Page 71of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1114 11141050; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 18AUG2020; Date of Last Dose: 08SEP2020
======================================================================================================================== ==
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1114 11141050, a 63-year-old white female with a pertinent medical history of depression (since 01 Jan1984), intervertebral disc degeneration (since 
18Aug 2005), hypertension (since 01 Jan2010), generalized rheumatoid arthritis (since 01 Jan2010), and sleep apnea syndrome (since 01 Jan2016), received Dose 1 on 
18Aug 2020 and Dose 2 on 08 Sep2020 (Day 22).  The subject experienced sudden cardiac death on 19 Oct2020, 41 days after receiving Dose 2.  
Concomitant medications included trazodone (since 01 Jan2005) for depression, pregabalin (since 01 Jan2005) for degenerative disc disease, amlodipine (since 
01Jan2010) for hypertension, baclofen (since 01 Jan2018) for degenerative disc disease, hydralazine (since 01 Feb 2020) for hype rtension, and sertraline (since 
01Jul2020) for depression. 
On 19 Oct2020 (Day 63), the emergency contact confirmed that the subject died.  An autopsy determined the cause of death as sudden cardiac death .  Of note, the subject 
had risk factors of hyper tension and obesity, which put her at high risk for cardiac/acute myocardial infarction death. 
In the opinion of the investigator, there was no reasonable possibility that the sudden cardiac death was related to the stud y intervention, concomitant medicat ions, or clinical 
trial procedures.  Pfizer concurred with the investigator’s causality assessment.  
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FDA-CBER-2021-5683-1016084
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1120 11201050; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 04AUG2020; Date of Last Dose: 27AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1962 58 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
158.5 cm 105 kg 41.8 kg/m2 04AUG2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Tubal ligation Female sterilisation 1982 Past
Post Menopausal Postmenopause 2011 Past
Chronic Back pain Back pain 2015 Past
cholecystectomy Cholecystectomy 2015 Past
Cholecystitis Cholecystitis 2015 Past
Hypertension Hypertension 2017 Present
Anxiety Anxiety 2018 Present
Diabetes mellitus Type II Type 2 diabetes mellitus 2018 Present
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FDA-CBER-2021-5683-1016085
Compound: PF -07302048; Protocol: C4591001 Page 73of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1120 11201050; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 04AUG2020; Date of Last Dose: 27AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, c m, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 04AUG2020 (1) 17:54
2 BNT162b2 27AUG2020 (24) 17:34
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)
1 CARD Cardiac arrest Cardiac arrest 07NOV2020 (96) 07NOV2020 (96) 1
Adverse Events
AE 
NumberToxicity 
GradeAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 4 W Y Fatal (07NOV2020) NOT RELATED/OTHER: Unknown 2 73 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1120 11201050; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 04AUG2020; Date of Last Dose: 27AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 04AUG2020
Completed VACCINATION 01OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 07NOV2020 DEATH
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1120 11201050; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 04AUG2020; Date of Last Dose: 27AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1120 11201050, a 58-year-old white female with a pertinent medical history of chronic back pain (since 2015), hypertension (since 2017), anxiety (sinc e 
2018), and type 2 diabetes mellitus (since 2018), received Dose 1 on 04 Aug 2020 and Do se2 on 27 Aug 2020 (Day 24).  The subject died of cardiac arrest on 07 Nov 2020, 
72days after receiving Dose 2.  
Concomitant medications included metformin (since 2017) for type 2 diabetes mellitus; lisinopril (since 2017) and clonidine (since 2018) bot h for hypertension; and 
lorazepam (since 2018) for anxiety. 
On 07 Nov 2020 (Day 96), the subject’s husband notified the site that the subject had died in her sleep.  The subject’s husband reported that the night before her death, she 
had taken an unspecified muscle relaxant and diazepam (Valium) for her chronic back pain; these medications were previously used by the subject.  No symptoms or 
illnesses leading to the subject’s death were reported.  The subject was not seen in the hospital.  The coroner was called to pronounce death; an autopsy was not performed.
On 04 Dec2020 (Day 123), the subject's husband stated that the cause of death on the death certificate was cardiac arrest (also described as car diopulmonary arrest).
In the opinion of the investigat or, there was no reasonable possibility that the cardiac arrest was related to the study intervention, concomitant medication s, or clinical trial 
procedures.  Pfizer concurred with the investigator’s causality assessment.  
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1120 11201266; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 10SEP2020; Date of Last Dose: 29SEP2020
==========================================================================================================================
PFIZER CONFI DENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1969 51 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
188 cm 87.6 kg 24.8 kg/m2 10SEP2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
codeine allergy Drug hypersensitivity 1988 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 10SEP2020 (1) 16:31
2 BNT162b2 29SEP2020 (20) 12:41
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1120 11201266; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 10SEP2020; Date of Last Dose: 29SEP2020
==========================================================================================================================
PFIZER CONFIDENTIA L  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)
1 EYE Blindness unilateral LOSS OF VISION LEFT EYE 04DEC2020 (86) ONGOING
2 NEOPL Lung cancer metastatic Metastatic Lung cancer 04DEC2020 (86) 19JAN2021 (132) 47
Adverse Events
AE 
NumberToxicity 
GradeAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 4 N Y Yes NOT RELATED/OTHER: UNKNOWN 2 67 Y
2 4 TC/W Y Fatal (19JAN2021) NOT RELATED/OTHER: UNKNOWN 2 67 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1120 11201266; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 10SEP2020; Date of Last Dose: 29SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 10SEP2020
Completed VACCINATION 27OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 19JAN2021 DEATH
Narrative Comment
Subject C4591001 1120 11201266, a 51-year-old white male with a pertinent medical history of drug hypersensitivity to codeine (since 1988), received Dose 1 on 
10Sep2020 and Dose 2 on 29 Sep2020 (Day 20).  On 04 Dec2020, the subject was diagnosed with m etastatic lung cancer and unilateral blindness, 66 days after receiving 
Dose 2.  
On 04 Dec2020 (Day 86), the subject went to an urgent care clinic because of blurred vision and was sent to the emergency room.  The subject was treated with 
levetiracetam 5 00mg, dexamethasone 4 mg, and oxycodone hydrochloride/paracetamol 5/325 mg.  
On an unspecified date in Dec 2020, 2 magnetic resonance imaging scans (1 with dye), 2 computed tomography scans (1 with dye), and a bronchial test (unspecified) were 
performed and the results were unspecified.  The doctors reported a diagnosis of metastatic lung cancer that had spread to the abdomen and brain; the subject also had lost 
vision in his left eye (unilateral blindness) with the onset date 04 Dec2020 (Day 86).  
On 1 9Jan2021 (Day 132), the subject died of the metastatic lung cancer.  The unilateral blindness was ongoing at the time of the subject’s deat h.  It was not reported if an 
autopsy was performed.  
In the opinion of the investigator, there was no reasonable possibility that the metastatic lung cancer and unilateral blindness were related to the study intervention, 
concomitant medications, or clinical trial procedures.  Pfizer concurred with the investigator’s causality assessment.
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1127 11271112; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 20AUG2020; Date of Last Dose: 10SEP2020
======================================================================================================================== ==
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1967 53 Multiple Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
168 cm 71.8 kg 25.4 kg/m2 20AUG2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Allergy to Chlor-Trimeton Drug hypersensitivity 1978 Present
Hypoglycemia Hypoglycaemia 1985 Present
Chronic obstructive pulmonary disease Chronic obstructive pulmonary disease 1990 Present
Tinnitus Tinnitus 1992 Present
Myocardial Infarction stress related Myocardial infarction 2008 Past
Myopia Myopia 2008 Present
Allergy to Tramadol Drug hypersensitivity 2015 Present
Recurrent seasonal allergies Seasonal allergy 2018 Present
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1127 11271112; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 20AUG2020; Date of Last Dose: 10SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 20AUG2020 (1) 18:55
2 BNT162b2 10SEP2020 (22) 14:57
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity 
Grade
1 CARD Cardio -respiratory arrest Cardiopulmonary arrest 04DEC2020 (107) 22:00 04DEC2020 (107) 1 4
Adverse Events
AE 
NumberAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 W Y Fatal (04DEC2020) NOT RELATED/OTHER: underlying cardiac disease 2 86 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1127 11271112; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 20AUG2020; Date of Last Dose: 10SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 20AUG2020
Completed VACCINATION 09OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 04DEC2020 DEATH
Narrative Comment
Subject C4591001 1127 11271112, a 53-year-old multiracial male with a pertinent medical history of hypoglycemia (since 1985), chronic obstructive pulmonary disease 
(since 1990), myocardial infarction (in 2008), and seasonal allergy (since 2018), received D ose1 on 20 Aug 2020 and Dose 2 on 10 Sep2020 (Day 22).  On 04 Dec2020, 
the subject died at 2200 hours, 85 days after receiving Dose 2, and the preliminary cause of death was reported as cardiopulmonary arrest on 18 Dec2020. 
On 04 Dec2020 (Day 107), t he subject went downstairs to do laundry, went back upstairs to get shampoo for a shower, and returned downstairs.  His mothe r went down to 
check on him since it had been a while and found that the subject was sitting cross -legged, leaning forward, and was blue in the face. 
On 05 Dec2020 (Day 108) at 1130 hours, the subject’s mother called the study site to report the subject’s death.  An autopsy was performed, and the results w ere not 
available at the time of this report. 
On 18 Dec2020, cardiopulmonary arrest was considered as the preliminary cause of death.
In the opinion of the investigator, there was no reasonable possibility that the cardiopulmonary arrest was related to the st udy intervention, concomitant medications, or 
clinical trial procedures, but rather it was due to the underlying cardiac disease.  Pfizer concurred with the investigator’s causality assessment.
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1128 11281009; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 31JUL2020; Date of Last Dose: 19AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1954 66 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
190.5 cm 128.59 kg 35.4 kg/m2 31JUL2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Tobacco Dependency Nicotine dependence 1970 Present
Vasectomy Vasectomy 1985 Past
Fluid Retention Fluid retention 1995 Present
High Blood Pressure Hypertension 1995 Present
diabetes mellitus type 2 Type 2 diabetes mellitus 1996 Present
Anxiety Anxiety 2000 Present
Restless Leg Syndrome Restless legs syndrome 2000 Present
High Cholesterol Blood cholesterol increased 2001 Present
Drug Allergy Diphendydramine Drug hypersensitivity 2005 Present
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1128 11281009; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 31JUL2020; Date of Last Dose: 19AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  S DTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Bilateral Hip Pain Arthralgia 17NOV2014 Present
Bilateral Hip Replacement Hip arthroplasty 17NOV2014 Past
intermittent Non -productive Cough Cough 2016 Present
Angina intermittent Angina pectoris 2017 Present
MYOCARDIAL INFARCTION Myocardial infarction 01JAN2017 Past
Coronary Arterial Stent placement Coronary arterial stent insertion 17JAN2017 Past
Vitamin D Deficiency Vitamin D deficiency MAY2020 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 31JUL2020 (1) 16:22
2 Placebo 19AUG2020 (20) 15:02
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity 
Grade
1 CARD Myocardial infarction Myocardial Infarction 27OCT2020 (89) 28OCT2020 (90) 2 4
2 INFEC Pneumonia Pneumonia 28OCT2020 (90) 28NOV2020 (121) 06:00 32 4
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1128 11281009; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 31JUL2020; Date of Last Dose: 19AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Adverse Events
AE 
NumberAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 N Y Resolved (28OCT2020) NOT RELATED/OTHER: failed cardiac stent 2 70 Y
2 TC/W Y Fatal (28NOV2020) NOT RELATED/OTHER: infection 2 71 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 31JUL2020
Completed VACCINATION 16SEP2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 28NOV2020 DEATH
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1128 11281009; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 31JUL2020; Date of Last Dose: 19AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM C reation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1128 11281009, a 66-year-old white male with a pertinent medical history of nicotine dependence (since 1970), fluid retention and hypertension (both 
since 1995), type 2 diabetes mellitus (since 1996), anxiety (since 2000), increased blood cholesterol (since 2001), cough (si nce 2016), angina pectoris (since 2017), 
myocardial infarction (on 01 Jan2017), coronary arterial stent insertion (on 17 Jan2017), and vitamin D deficiency (since May 2020), received Dose 1 on 31 Jul2020 and 
Dose 2 on 19 Aug 2020 (Day 20).  The subject was diagno sed with myocardial infarction on 27 Oct2020 and pneumonia on 28 Oct2020, 69 days and 70 days after 
receiving Dose 2, respectively.  He died from progression of pneumonia, on 28 Nov 2020, 101 days after receiving Dose 2.
Concomitant medications included vitamin D2 (since May 2000) for vitamin D deficiency, pramipexole (since 2000) for restless legs syndrome, clonazepam (since 2000) for 
an unknown indication, glimepiride (since 2010) for type 2 diabetes mellitus, clopidogrel (since 2011) for increased bloo d cholesterol, clonidine hydrochloride (since 2014) 
for hypertension, gabapentin (since 2014) for bilateral hip pain, benzonatate (since 2016) for cough, nitroglycerin (since 2017) for angina, and furosemide (sinc e 
09Sep2020) for fluid retention.  
On 27 Oct2020 (Day 89), the subject had a myocardial infarction due to failure of a cardiac stent that resulted in hospitalization.  The failed stent was removed and replaced.
On 28 Oct2020 (Day 90), the myocardial infarction was considered resolved.  After s tent replacement procedure, the subject developed pneumonia on 28 Oct2020 (Day 90) 
and was discharged against medical advice on 30 Oct2020 (Day 92).  
On an unknown date, the site contacted the subject regarding a missed e -diary entry, during which the subject’s wife reported that the subject had died at home on 
28Nov 2020 (Day 121) at 0600 hours because of pneumonia.  The site requested the subject’s death certificate, which was pending at the time of this report .  No autopsy was 
performed.  
In the opi nion of the investigator, there was no reasonable possibility that the myocardial infarction and pneumonia were related to th e study intervention, concomitant 
medications, or clinical trial procedures.  Pfizer concurred with the investigator’s causality as sessment.
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1129 11291166; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 08SEP2020; Date of Last Dose: 28SEP2020
========================================================================================================= =================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1942 78 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
162.56 cm 59.09 kg 22.3 kg/m2 08SEP2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
depression Depression 1950 Present
bilateral astigmatism Astigmatism 1955 Present
hyperopia Hypermetropia 1965 Present
myopia Myopia 1965 Present
Surgical tape allergy Dermatitis contact 1980 Present
hypercholesterolemia Hypercholesterolaemia 2009 Present
right cataracts Cataract 2017 Past
left cataracts Cataract 2017 Present
hearing loss Deafness 2017 Present
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1129 11291166; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 08SEP2020; Date of Last Dose: 28SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
hiatal hernia Hiatus hernia 2017 Present
osteoporosis Osteoporosis 2018 Present
diarrhea Diarrhoea DEC2019 Past
esophageal stricture Oesophageal stenosis MAR2020 Past
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 08SEP2020 (1) 13:10
2 BNT162b2 28SEP2020 (21) 12:15
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)
1 CARD Myocardial infarction myocardial infarction 03FEB2021 (149) 03FEB2021 (149) 1
Adverse Events
AE 
NumberToxicity 
GradeAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 4 W Y Fatal (03FEB2021) NOT RELATED/OTHER: hyperlipidemia 2 129 Y
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1129 11291166; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 08SEP2020; Date of Last Dose: 28SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 08SEP2020
Completed VACCINATION 26OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 03FEB2021 DEATH
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1129 11291166; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 08SEP2020; Date of Last Dose: 28SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nd a2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1129 11291166, a 78-year-old white female with a pertinent medical history of hypercholesterolemia (since 2009); peripheral arterial occlusive disease
(since 02 Feb2019); esophageal stenosis (in Mar 2020); diastolic dysfunction (Grade 1; since 14 Aug 2020); and elevated blood pressure, angiopathy, current tobacco use, 
and gastroesophageal reflux disease (all on unknown dates), received Dose 1 on 08 Sep2020 and Dose 2 on 28 Sep2020 (Day 21).  The subject died of a myocardial 
infarction on 03 Feb 2021, 128 days after receiving Dose 2.  
Concomitant medications included atorvastatin (since 2017) for hypercholesterolemia, omeprazole (since 2017) for hiatal hernia, citalopram hydrobromide (since 2017) for 
depression, and denosumab (since 2018) for osteoporosis.  
On 03 Jan2021 (Day 118), the subject had visited a doctor and it was reported that she was feeling well at this time.  It was reported that the subject did not have any side 
effects after receiving Dose 1 and Dose 2.  On 08 Jan2021 (Day 123), the family spoke to the subject for the last time.
The site received a call from the subject’s son reporting that his mother had died on 03 Feb2021 (Day 149); the subject’s neighbors found her body in her apartment because 
of the odor.  When the subject’s son arrived, he found that there was a large amount of blood and fluids pooled on the floor around her body.  Her s kin was mottled, bruised, 
and rigid.  The emergency medical technician noted no lacerations that could cause the pool of blood and estimated that she might have died 3 to 5 days before her body was 
found.  The cause of death was reported as myocardial infarction per the medical examiner.  No autopsy was performed.  
In the opinion of the investigator, there was no reasonable possibil ity that the myocardial infarction was related to the study intervention, concomitant medications, or clinical 
trial procedures, but rather it was related to hyperlipidemia. Pfizer concurred with the investigator’s causality assessment.
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1131 11311204; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 22SEP2020; Date of Last Dose: 21JAN2021
============================================================================================================= =============
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1936 84 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
172.8 cm 91 kg 30.5 kg/m2 22SEP2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
tobacco use, past, 6 cigarettes per day Ex-tobacco user 1945 Past
allergic rhinitis, seasonal Seasonal allergy 1985 Past
eye glass wearer Corrective lens user 1995 Present
cataract surgery in both eyes Cataract operation 2000 Past
osteoarthritis, generalized Osteoarthritis 2000 Present
hip replacement Hip arthroplasty 2002 Past
right knee replacement surgery Knee arthroplasty 2004 Past
erectile dysfunction Erectile dysfunction 2005 Present
left knee replacement surgery Knee arthroplasty 2005 Past
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1131 11311204; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 22SEP2020; Date of Last Dose: 21JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
aortic stenosis Aortic stenosis 2010 Present
hearing problems Auditory disorder 2010 Present
dentures Denture wearer 2013 Present
carpal tunnel syndrome, bilaterally Carpal tunnel syndrome 2015 Present
memory changes Memory impairment 2015 Present
atrial fibrillation Atrial fibrillation 2018 Present
cerebrovascular accident Cerebrovascular accident 2018 Past
heart murmur Cardiac murmur 2019 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 22SEP2020 (1) 14:28
2 Placebo 15OCT2020 (24) 10:49
3 BNT162b2 21JAN2021 (122) 11:53
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity
Grade
1 VASC Aortic stenosis Worsening Aortic Stenosis 05FEB2021 (137) 13FEB2021 (145) 9 3
2 CARD Cardio -respiratory arrest Cardiopulmonary Arrest 15FEB2021 (147) 12:35 15FEB2021 (147) 13:35 1 4
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1131 11311204; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 22SEP2020; Date of Last Dose: 21JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, c m, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Adverse Events
AE 
NumberAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 N Y Resolved (13FEB2021) NOT RELATED/OTHER: atherosclerosis 3 16 Y
2 W Y Fatal (15FEB2021) NOT RELATED/OTHER: Cerebrovascular Event 3 26 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 22SEP2020
Completed VACCINATION 12NOV2020
Completed REPEAT SCREENING 1 21JAN2021
Withdrawn OPEN LABEL TREATMENT 15FEB2021 DEATH
Withdrawn FOLLOW -UP 15FEB2021 DEATH
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1131 11311204; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 22SEP2020; Date of Last Dose: 21JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Sourc e Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1131 11311204, an 84 -year-old white male with a pertinent medical history of former tobacco use (6 cigarettes per day from 1945 to an unknown date), 
seasonal allergy (in 1985), aortic stenosis (since 2010), memory impairment (since 2015), cerebrovascular accident (in 2018), atrial fibrillation (since 2018), and cardiac 
murmur (since 2019), received Dose 1 on 22 Sep2020 and Dose 2 on 15 Oct2020 (Day 24).  
Concomitant medication included apixaban (since Apr 2018) for a cerebrovascular acci dent.  
In accordance with the protocol allowance, the subject agreed to be unblinded to determine whether he was eligible for receip t of BNT162b2.  It was confirmed that he had 
originally received placebo; the subject therefore received the first dose of BNT162b2 on 21 Jan2021 (Day 122), and remained in the study until 15 Feb2021 (Day 147).  
The subject was diagnosed with worsening aortic stenosis on 05 Feb2021 and cardiopulmonary arrest on 15 Feb 2021, 15 days and 25 days after receiving the first dose of 
BNT162b2, respectively.  He died of cardiopulmonary arrest on 15 Feb2021 (Day 147), 25 days after receiving the first dose of BNT162b2.  
The subject’s wife reported that the subject had experienced shortness of breath and was taken to the emergency r oom on 05 Feb2021 (Day 137).  Subsequently, the subject 
was hospitalized on the same day (Day 137) because of the worsening of aortic stenosis.  The subject underwent an angiogram, and a stent insertion was recommended.   On 
16Feb2021 (Day 148), the subj ect’s wife reported that the worsening of aortic stenosis was considered resolved, and the subject was discharged from the ho spital on 
13Feb2021 (Day 145).  She also reported that the subject had lain down for a nap on 15 Feb2021 (Day 147) and never wok e up.  The subject’s wife was unaware of the 
cause of death.  She also reported that the stent insertion was not completed during the hospitalization, as the cardiologist did not feel it was an urgent need.  Later, on 
05Mar 2021, a death certificate recei ved from the subject’s primary care physician stated that the immediate cause of death was cardiopulmonary arrest secondary t o 
cerebrovascular event.  An autopsy was not performed.
In the opinion of the investigator, there was no reasonable possibility tha t the worsening aortic stenosis and cardiopulmonary arrest were related to BNT162b2, concomitant 
medications, or clinical trial procedures.  Pfizer concurred with the investigator’s causality assessment.
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1135 11351033; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 05AUG2020; Date of Last Dose: 25JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1953 67 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
178 cm 101.9 kg 32.2 kg/m2 05AUG2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
nearsighted Myopia 1966 Present
anxiety Anxiety 1991 Present
cholecystectomy Cholecystectomy 1991 Past
gallbladder stones Cholelithiasis 1991 Past
depression Depression 1998 Present
hearing loss Deafness 2010 Present
bone spur surgery Bone lesion excision 2017 Past
cataracts Cataract 2017 Present
Rt foot bone spur Exostosis 2017 Past
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1135 11351033; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 05AUG2020; Date of Last Dose: 25JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
septoplasty Nasal septal operation 2017 Past
deviated nasal septum Nasal septum deviation 2017 Past
hypertension Hypertension JAN2020 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 05AUG2020 (1) 13:31
2 Placebo 27AUG2020 (23) 11:32
3 BNT162b2 25JAN2021 (174) 10:26
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)
1 PSYCH Completed suicide Suicide 29JAN2021 (178) 00:00 29JAN2021 (178) 00:00 1
2 NERV Hypoaesthesia numbness on the back of the head 04SEP2020 (31) 04SEP2020 (31) 1
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1135 11351033; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 05AUG2020; Date of Last Dose: 25JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Adverse Events
AE 
NumberToxicity 
GradeAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 4 W Y Fatal (29JAN2021) NOT RELATED/OTHER: unknown 3 5 Y
2 1 N N Resolved (04SEP2020) NOT RELATED/OTHER: muscle strain 2 9 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 05AUG2020
Completed VACCINATION 24SEP2020
Completed REPEAT SCREENING 1 25JAN2021
Withdrawn OPEN LABEL TREATMENT 29JAN2021 DEATH
Withdrawn FOLLOW -UP 29JAN2021 DEATH
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1135 11351033; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 05AUG2020; Date of Last Dose: 25JAN2021
=============================================================================================== ===========================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1135 11351033, a 67-year-old white male with a pertinent medical history of anxiety (since 1998) and depression (since 1991), received Dose 1 on 
05Aug 2020 and Dose 2 on 27 Aug 2020 (Day 23).  
Concomitant medications included diazepam (from 1991 to 29 Jan2021) for anxiety, paroxetine hydrochloride (from 1998 to 29 Jan2021) for depression, and losartan (from 
Jan2020 to 29 Jan2021) for hypertension.  
In accordance with the protocol allowance, the subject agreed to be unblinded to determine whether he was eligible for receipt of BNT162b2.  It was confirmed that he had 
originally received placebo; the subject therefore received the first dose of BNT162b2 on 25 Jan2021 (Day 174) and remained in the study until 29 Jan2021 (Day 178).  The 
subject committed suicide and died on 29 Jan2021, 4 days after receiving the first dose of BNT162b2.
When the subject missed his Visit 102, the site attempted to contact him, but the site was unsuccessful and called an emergency contact .  The emergency contact reported that 
the subject had committed suicide and died on 29 Jan2021 (Day 178).  An autopsy was performed.  
In the opinion of the investigator, there was no reasonable possibility that the suicide was related to the BNT162b2, c oncomitant medications, or clinical trial procedures.  
Pfizer concurred with the investigator’s causality assessment.  
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1136 11361102; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 29OCT2020; Date of Last Dose: 19NOV2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1944 76 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
172.72 cm 60 kg 20.1 kg/m2 29OCT2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
congenital heart defect Heart disease congenital 1944 Past
patent ductus arteriosus heart surgery Patent ductus arteriosus repair 1947 Past
patent ductus arteriosus heart surgery Patent ductus arteriosus repair 1949 Past
appendectomy Appendicectomy 1954 Past
appendicitis Appendicitis 1954 Past
bilateral hearing loss Deafness bilateral 1957 Present
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1136 11361102; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 29OCT2020; Date of Last Dose: 19NOV2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, v s, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 29OCT2020 (1) 12:21
2 BNT162b2 19NOV2020 (22) 12:13
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)
1 CARD Cardiac arrest cardiac arrest 19DEC2020 (52) 00:00 19DEC2020 (52) 00:00 1
2 GENRL Injection site pain injection site pain, right 20NOV2020 (23) 00:00 21NOV2020 (24) 00:00 2
3 GENRL Injection site pain sore in injection site, right arm 29OCT2020 (1) 00:00 29OCT2020 (1) 00:00 1
Adverse Events
AE 
NumberToxicity 
GradeAction to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 4 TC/TCN/W Y Fatal (19DEC2020) NOT RELATED/OTHER: cardiac related 2 31 Y
2 1 N N Resolved (21NOV2020) Study Treatment 2 2 N
3 1 N N Resolved (29OCT2020) Study Treatment 1 1 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1136 11361102; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 29OCT2020; Date of Last Dose: 19NOV2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 29OCT2020
Withdrawn VACCINATION 19DEC2020 DEATH
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 19DEC2020 DEATH
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1136 11361102; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 29OCT2020; Date of Last Dose: 19NOV2020
======================================================================================================================== ==
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1136 11361102, a 76-year-old white male with a pertinent medical history of congenital heart disease ( 1944 to 1949) that was surgically repaired 
(patent ductus arteriosus repair in 1947 and 1949), appendicitis and appendectomy (both in 1954), and bilateral deafness (sin ce 1957), received Dose 1 on 29 Oct2020 and 
Dose 2 on 19 Nov 2020 (Day 22).  Th e subject died of cardiac arrest on 19 Dec2020, 30 days after receiving Dose 2.
Concomitant medication included multivitamins (since an unknown date) for health maintenance. 
On 22 Jan2021, after multiple attempts to contact the subject, the site communi cated with the subject’s emergency contact, who confirmed that the subject had died after 
experiencing sudden cardiac arrest while on a walk.  On 19 Dec2020 (Day 52), the subject suddenly collapsed while on a walk.  The subject was unresponsive and 
cardio pulmonary resuscitation was performed.  An ambulance was called, and the emergency medical services found the subject to have ventricular tachycardia (heart rate 
not reported) followed by ventricular fibrillation.  Two rounds of defibrillation with 3 round s of epinephrine were done.  Chest compressions and epinephrine, calcium, 
sodium bicarbonate, and amiodarone were administered.  An echocardiogram performed at bedside revealed cardiac standstill.  R esuscitation efforts were terminated, and the 
subject die d on the same day (Day 52) because of a cardiac arrest.  It was unknown if an autopsy was performed.
In the opinion of the investigator, there was no reasonable possibility that the cardiac arrest was related to the study inte rvention, concomitant medicati ons, or clinical trial 
procedures. Pfizer concurred with the investigator’s causality assessment.
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1140 11401117; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 14AUG2020; Date of Last Dose: 04SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unb linded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1961 58 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
190.5 cm 138.73 kg 38.1 kg/m2 14AUG2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
obesity Obesity 01JAN1978 Present
bilateral Knee pain Arthralgia 01AUG2010 Present
Knee Replacement Knee arthroplasty 01FEB2014 Past
Osteoarthritis Osteoarthritis 01FEB2014 Present
Coronary Artery Disease Coronary artery disease 01AUG2015 Present
Depression Depression 01AUG2018 Present
Hypertension Hypertension 01AUG2018 Present
Hyperlipidemia Hyperlipidaemia 01JUN2019 Present
Hyperglycemia Hyperglycaemia JUN2020 Present
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1140 11401117; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 14AUG2020; Date of Last Dose: 04SEP2020
============================================================================================== ============================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 14AUG2020 (1) 12:08
2 BNT162b2 04SEP2020 (22) 09:07
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity
Grade
1 CARD Cardiac arrest Cardiac Arrest 29DEC2020 (138) 29DEC2020 (138) 13:59 1 4
Adverse Events
AE 
NumberAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 W Y Fatal (29DEC2020) NOT RELATED/OTHER: Underlying Comorbidities 2 117 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1140 11401117; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 14AUG2020; Date of Last Dose: 04SEP2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 14AUG2020
Completed VACCINATION 02OCT2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 29DEC2020 DEATH
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FDA-CBER-2021-5683-1016117
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1140 11401117; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 14AUG2020; Date of Last Dose: 04SEP2020
======================================================================================================================== ==
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1140 11401117, a 58-year-old white male with a pertinent medical history of obesity (since 01 Jan1978), coronary artery disease (since 01 Aug 2015), 
depression and hypertension (both since 01 Aug 2018), hyperlipidemia (since 01 Jun2019), and hyperglycemia (since Jun 2020; glycosylated hemoglobin of 5.7 in 
Jun2020), received Dose 1 on 14 Aug 2020 and Dose 2 on 04 Sep2020 (Day 22).  The subject died of cardiac arrest on 29 Dec2020, 116 days after receiving Dose 2.  
Concomitant medicatio ns included meloxicam (since 01 Aug 2010) for bilateral knee pain, vitamin D3 (since 01 Aug 2015) for general health, hydrochlorothiazide and 
losartan (both since 01 Aug 2018) for hypertension, sertraline (since 01 Oct2018) for depression, acetylsalicylic acid (since 01 Jun2020) for coronary artery disease, 
pravastatin (since 01 Jun2020) for hyperlipidemia, and dulaglutide (since 07 Dec2020) for hyperglycemia.  
On 29 Dec2020 (Day 138), the subject experienced seizure -like activity and collapsed; he wa s taken to the emergency room (ER) in cardiac arrest with bystander 
cardiopulmonary resuscitation (CPR) and electrical muscle stimulation (EMS) CPR.  The subject was initially found to be in ve ntricular tachycardic arrest and he received 
amiodarone and epi nephrine along with subsequent CPR attempts.  Per emergency medical services, he received 5 rounds of epinephrine, 1 ampoule of sodium bicarbonate, 
1g calcium chloride, 1 mg atropine, and 300 mg amiodarone.  The subject’s cardiac rhythm was asystole befor e arrival at the ER, and he was unresponsive upon physical 
examination.  He was defibrillated with 200 J of biphasic electricity but continued to be in pulseless electrical activity an d pulseless ventricular fibrillation.  Despite 
appropriate CPR, the subj ect's carbon dioxide continued to drop and a bedside echocardiogram showed no cardiac activity with complete cardiac standsti ll.  Resuscitative 
efforts were ceased because of the significantly decreased probability of regaining spontaneous circulation.  Th e subject died of cardiac arrest on 29 Dec2020 (Day 138) at 
1359 hours.  No autopsy was performed.  Of further note, the subject had reported “sniffles” on 07 Dec2020 (Day 116), which was not considered to be serious, and had a 
blood test on an unspecifi ed date that showed COVID -19 antibodies.
In the opinion of the investigator, there was no reasonable possibility that the cardiac arrest was related to the study inte rvention, concomitant medications, or clinical trial 
procedures, but rather it was related to underlying comorbidities.  Pfizer concurred with the investigator’s causality assessment.  
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1152 11521085; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 19AUG2020; Date of Last Dose: 19AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1978 42 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
172.72 cm 84.09 kg 28.1 kg/m2 19AUG2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
chronic sinusitis Chronic sinusitis 2000 Present
seasonal allergies Seasonal allergy 2000 Present
breast cancer Breast cancer 2001 Past
lumpectomy left breast Breast conserving surgery 2001 Past
breast cancer Breast cancer 2017 Past
lumpectomy left breast Breast conserving surgery 2017 Past
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(b) (6)
FDA-CBER-2021-5683-1016119
Compound: PF -07302048; Protocol: C4591001 Page 107of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1152 11521085; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 19AUG2020; Date of Last Dose: 19AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 19AUG2020 (1) 10:38
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity
Grade
1 GENRL Death UNDETERMINED CAUSE OF 
DEATH26AUG2020 (8) 26AUG2020 (8) 1 4
Adverse Events
AE 
NumberAction 
to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 P/W Y Fatal (26AUG2020) NOT RELATED/OTHER: UNDETERMINED CAUSE OF DEATH 1 8 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
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FDA-CBER-2021-5683-1016120
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1152 11521085; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 19AUG2020; Date of Last Dose: 19AUG2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C459 1001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 19AUG2020
Withdrawn VACCINATION 26AUG2020 DEATH
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 26AUG2020 DEATH
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FDA-CBER-2021-5683-1016121
Compound: PF -07302048; Protocol: C4591001 Page 109of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1152 11521085; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 19AUG2020; Date of Last Dose: 19AUG2020
=================================================================================================================== =======
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1152 11521085, a 42-year-old white female with a pertinent medical history of recurrent breast cancer (in 2001 and 2017), treated with lumpectomy and 
radiation on unknown dates, and implantation of an Essure permanent birth control device (implanted in 2017), received Dose 1 on 19 Aug 2020.  The subject was not taking 
any concomitant medications.  The subject died (cause of death was undetermined) on 26 Aug 2020, 7 days after receiving Dose 1. 
The subject’s husband stated that the subject had no adverse events after receiving Dose 1.  On 25 Aug 2020 (Day 7), she had a normal evening and went to bed.  On 
26Aug 2020 (Day 8), the husband found that the subject had died and the cause of death was undetermined.  On 02 Jan2021, the subject's hu sband reported that the medical 
examiner stated that the subject died from sudden cardiac failure brought on by 2 rounds of radiation for recurring breast cancer, which weakened her heart.  The subject had 
no changes in her health and medications.  Essure was still in place at the time of death.  The investigator felt that the cause of death was sudden cardiac failure from 
radiation therapy on 2 separate occasions for breast cancer.  However, this could not be confirmed.  During the follow -up report, it was reported that the medical examiner's 
office determined the cause of death as "undetermined."  An autopsy was performed and the results were still pending at the t ime of this report.
In the opinion of the investigator, there was no reasonable possibility t hat the death was related to the study intervention.  The investigator further stated that although the full 
autopsy report was pending and determining cause of death at this time was essentially an educated guess, the subject had pos sible risk factors.  S he possibly had a 
thromboembolic event related to a history of breast cancer, or there was a potential toxicity related to the Essure permanent birth control device.  The subject had an Essure 
implant since 2017 for permanent birth control that was taken o ff the market in the United States by the Food and Drug Administration (FDA) in 2018.  A brief review 
revealed almost 50,000 reports to the FDA regarding the device and approximately 50 deaths.  The investigator stated that Ess ure was a concomitant device that was a 
cosuspect in the subject’s death.  Pfizer concurred with the investigator’s causality assessment.
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1152 11521497; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 07OCT2020; Date of Last Dose: 07OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unb linded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
1948 72 White Hispanic/Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
176.53 cm 78.27 kg 25.1 kg/m2 07OCT2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
lithotripsy Lithotripsy 1999 Past
nephrolithiasis Nephrolithiasis 1999 Past
allergy to mango Food allergy 2000 Present
allergy to celery Food allergy 2000 Present
hearing loss Deafness 2010 Present
osteoarthritis Osteoarthritis 2010 Present
Type II diabetes Type 2 diabetes mellitus 2010 Present
hypertension Hypertension 2018 Present
prostatism Prostatism 2019 Present
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FDA-CBER-2021-5683-1016123
Compound: PF -07302048; Protocol: C4591001 Page 111of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1152 11521497; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 07OCT2020; Date of Last Dose: 07OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 07OCT2020 (1) 12:52
Adverse Events
AE 
NumberMedDRA 
SOCMedDRA Preferred 
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop 
TimeDuration
(Days)Toxicity 
Grade
1 INFEC Shigella sepsis sepsis related to Shigella infection 26OCT2020 (20) 11NOV2020 (36) 17 4
2 NERV Syncope vasovagal syncope 26OCT2020 (20) 26OCT2020 (20) 1 3
Adverse Events
AE 
NumberAction to 
Subject SAE AE Still Present? AE Related To:Prior 
Vaccination
NumberRelative Day 
From Prior
VaccinationNarrative
Event
1 TC/TCN/W Y Fatal (11NOV2020) NOT RELATED/OTHER: Shigella infection 1 20 Y
2 N N Resolved (26OCT2020) NOT RELATED/OTHER: sepsis related to shigella infection 1 20 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016124
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Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1152 11521497; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 07OCT2020; Date of Last Dose: 07OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: dm, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion 
Date Reason for Withdrawal
Completed SCREENING 07OCT2020
Withdrawn VACCINATION 11NOV2020 DEATH
REPEAT SCREENING 1
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 11NOV2020 DEATH
090177e196e6793b\Final\Final On: 28-Apr-2021 12:12 (GMT)
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FDA-CBER-2021-5683-1016125
Compound: PF -07302048; Protocol: C4591001 Page 113of 157
Reason(s) for Narrative: Death
Unique Subject ID: C4591001 1152 11521497; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 07OCT2020; Date of Last Dose: 07OCT2020
==========================================================================================================================
PFIZER CONFIDENTIAL  SDTM Creation: 25MAR2021 (23:24)  Source Data: d m, vs, mh, ex, ae, cm, ds  Output 
File: ./nda2_unblinded/C4591001_BLA_Narrative_Safety/profile  Date of Generation: 01APR2021 (10:49)Narrative Comment
Subject C4591001 1152 11521497, a 72-year-old white male with a pertinent medical history of type 2 diabetes mellitus and osteoarthritis (both since 2010) and 
hypertension (since 2018), received Dose 1 on 07 Oct2020.  On 26 Oct2020, the subject was diagnosed with Shigella sepsis, 19 days after receiving Dose 1, and the subject 
died of the event on 11 Nov 2020, 35 days after receiving Dose 1.
Concomitant medications included metformin (since 2013) for diabetes, ibuprofen (since 2015) for osteoarthritis, lisinopril ( since 2018) for hyperten sion, and doxazosin 
(since 2019) for benign prostatic hypertrophy.
On 06 Nov 2020 (Day 31), it was reported that the subject was admitted to the hospital on 26 Oct2020 (Day 20) after he fainted in the middle of the night.  On the same day 
(Day 20), the sy ncope resolved.  Per medical records from the hospital admission, the subject complained of diarrhea for 2 days, with associa ted nausea, intermittent 
vomiting, and increasing lethargy.  On arrival, he was febrile (body temperature was not reported) and hyp otensive (blood pressure was not reported).  The s
…[truncated]