Document text
Compound: PF -07302048; Protocol: C4591001 Page 1of 16
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PFIZER CONFIDENTIAL SDTM Creation: . (.) Source Data: adsl Output File: ./nda2/C4591001_Narratives_Abbr/profile Date of Generation: 15FEB2021
(21:40)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P Drug withdrawn (study intervention discontinued)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W Withdrawn from study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
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FDA-CBER-2022-5812-0500178
Compound: PF-07302048; Protocol: C4591001 Page 2of 16
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PFIZER CONFIDENTIAL SDTM Creation: . (.) Source Data: adsl Output File: ./nda2/C4591001_Narratives_Abbr/profile Date of Generation: 15FEB2021
(21:40)Table of Abbreviations
Category Abbreviation Text
RENAL Renal and urinary disorders
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
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FDA-CBER-2022-5812-0500179
Compound: PF -07302048; Protocol: C4591001 Page 3of 16
Reason(s) for Narrative: Safety -Related Subject Withdrawal
Unique Subject ID: C4591001 1006 10061272; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 16DEC2020; Date of Last Dose: 16DEC2020
===================================================================================== =====================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Safety/profile Date of Generation: 01APR2021 (10:32)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2007 13 Black or African American Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
172.72 cm 67.27 kg 22.5 kg/m2 16DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Attention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorder 2010 Present
Separation Anxiety Disorder Separation anxiety disorder 2010 Present
Disruptive Mood Dysregulation Disorder Disruptive mood dysregulation disorder 2012 Present
Asthma Asthma 2013 Present
Anxiety Anxiety 2014 Present
Depression Depression 2014 Present
Recurring Insomnia Insomnia 2014 Present
Recurring Nightmares Nightmare 2015 Present
Post Traumatic Stress Disorder Post-traumatic stress disorder 06NOV2015 Present
Aggressive Behaviors Aggression 2017 Past
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(b) (6)
FDA-CBER-2022-5812-0500180
Compound: PF -07302048; Protocol: C4591001 Page 4of 16
Reason(s) for Narrative: Safety -Related Subject Withdrawal
Unique Subject ID: C4591001 1006 10061272; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 16DEC2020; Date of Last Dose: 16DEC2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh , ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Safety/profile Date of Generation: 01APR2021 (10:32)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 16DEC2020 (1) 12:07
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 PSYCH Anxiety Worsening of anxiety 23DEC2020 (8) 18JAN2021 (34) 27
2 INJ&P Contusion Contusion left elbow 05FEB2021 (52) ONGOING
3 PSYCH Depression Worsening of Depression 23DEC2020 (8) 18JAN2021 (34) 27
Adverse Events
AE
NumberToxicity
GradeAction to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 3 TC/TCN/P Y Resolved (18JAN2021) NOT RELATED/OTHER: Stress 1 8 Y
2 1 N N Yes NOT RELATED/OTHER: Fall on ice 1 52 N
3 3 TC/TCN/P Y Resolved (18JAN2021) NOT RELATED/OTHER: Stress 1 8 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
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FDA-CBER-2022-5812-0500181
Compound: PF -07302048; Protocol: C4591001 Page 5of 16
Reason(s) for Narrative: Safety-Related Subject Withdrawal
Unique Subject ID: C4591001 1006 10061272; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 16DEC2020; Date of Last Dose: 16DEC2020
==================================== ======================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Safety/profile Date of Generation: 01APR2021 (10:32)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 16DEC2020
Withdrawn VACCINATION 06JAN2021 ADVERSE EVENT
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b13481\Final\Final On: 02-Apr-2021 08:33 (GMT)
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FDA-CBER-2022-5812-0500182
Compound: PF -07302048; Protocol: C4591001 Page 6of 16
Reason(s) for Narrative: Safety -Related Subject Withdrawal
Unique Subject ID: C4591001 1006 10061272; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 16DEC2020; Date of Last Dose: 16DEC2020
================================================================================================================== ========
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Safety/profile Date of Generation: 01APR2021 (10:32)Narrative Comment
Subject C4591001 1006 10061272, a 13-year-old black or African American female with a pertinent medical history of attention deficit hyperactivity disorder and separation
anxiety disorder (both since 2010); disruptive mood dysregulation disorder (since 2012); anxiety, depression, and recurring i nsomnia (all since 2014); recurring nightmares
(since 2015); posttraumatic stress disorder (since 06 Nov 2015); and aggression (in 2017 with 4 days’ hospitalization), received Dose 1 on 16 Dec2020. The family medical
history was pertinent for posttraumatic stress disorder, borderline personality disorder ), and drug add iction ). The subject experienced
worsening of anxiety and worsening of depression on 23 Dec2020, 7 days after receiving Dose 1.
Concomitant medications included salbutamol and fluticasone propionate (both since 2013) and montelukast so dium (from 2013 to 30 Dec2020) for asthma; and duloxetine
hydrochloride (from 2019 to 30 Dec2020) and citalopram hydrobromide (from Oct 2020 to 30 Dec2020), both for depression.
The subject, with an ongoing medical history of anxiety and depression, w hich were stable at Visit 1, experienced worsening of anxiety and depression after Visit 1 on
23Dec2020 (Day 8) and was hospitalized for 14 days. During hospitalization, the subject was seen by a physician and was treated with aripiprazole 1 mg and venl afaxine
150mg per day (starting on 30 Dec2020) and the physician recommended admission to an inpatient residential treatment/psychiatric facility. On 05 Jan2021 (Day 21), the
subject was admitted to an inpatient residential treatment/psychiatric facili ty for medical management and stabilization. The subject was not tested for COVID -19. During a
scheduled visit, the subject and her guardian stated that the subject’s mental health had stabilized, and she was treated wit h trazodone 50 mg every night (fro m 06 Jan2021)
for her history of recurring insomnia. On 18 Jan2021 (Day 34), the worsening of anxiety and worsening of depression resolved and the subject was discharged from the
hospital on the same day.
The subject was discontinued from the study intervention on 06 Jan2021 because of the worsening of anxiety and depression and remains in the study to be evaluated for
safety, immunogenicity, and efficacy.
In the opinion of the investigator, there was no reasonable possibility that the worsening of anxiety and worsening of depression were related to the study intervention,
concomitant medications, or clinical trial procedures, but rather they were related to stress. Pfizer did not assess the worsening of anxiety and worsening of depression as
relate d to the study intervention, concomitant medications, or clinical trial procedures.
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(b) (6)
(b) (6)
FDA-CBER-2022-5812-0500183
Compound: PF-07302048; Protocol: C4591001 Page 7of 16
Reason(s) for Narrative: Safety -Related Subject Withdrawal
Unique Subject ID: C4591001 1147 11471327; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 05JAN2021; Date of Last Dose: 05JAN2021
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PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Safety/profile Date of Generation: 01APR2021 (10:32)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2006 14 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
167.64 cm 76 kg 27 kg/m2 05JAN2021 (1)
Medical History
No Medical History
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 05JAN2021 (1) 17:10
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(b) (6)
FDA-CBER-2022-5812-0500184
Compound: PF -07302048; Protocol: C4591001 Page 8of 16
Reason(s) for Narrative: Safety -Related Subject Withdrawal
Unique Subject ID: C4591001 1147 11471327; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 05JAN2021; Date of Last Dose: 05JAN2021
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PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Outpu t
File: ./nda2_unblinded/C4591001_EUA_Narrative_Safety/profile Date of Generation: 01APR2021 (10:32)Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
Time
1 GENRL Pyrexia Fever (104.7) 06JAN2021 (2) 19:30 08JAN2021 (4)
Adverse Events
AE
NumberDuration
(Days)Toxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 3 4 TC/P N Resolved (08JAN2021) Study Treatment 1 2 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vacci nes
090177e196b13481\Final\Final On: 02-Apr-2021 08:33 (GMT)
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FDA-CBER-2022-5812-0500185
Compound: PF -07302048; Protocol: C4591001 Page 9of 16
Reason(s) for Narrative: Safety -Related Subject Withdrawal
Unique Subject ID: C4591001 1147 11471327; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 05JAN2021; Date of Last Dose: 05JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591 001_EUA_Narrative_Safety/profile Date of Generation: 01APR2021 (10:32)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 05JAN2021
Withdrawn VACCINATION 08JAN2021 ADVERSE EVENT
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
Narrative Comment
Subject C4591001 1147 11471327, a 14-year-old white male with no reported medical history, received Dose 1 on 05 Jan2021. The subject experienced pyrexia (fever
104.7°F) on 06 Jan2021, 1 day after receiving Dose 1.
The pyrexia resolved on 08 Jan2021 (Day 4).
The subject was discontinued from the study intervention on 08 Jan2021 because of the pyrexia and remains in the study to be evaluated for safety, immunogenicity, and
efficacy.
In the opinion of the investigator, there was a reasonable possib ility that the pyrexia was related to the study intervention.
090177e196b13481\Final\Final On: 02-Apr-2021 08:33 (GMT)
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FDA-CBER-2022-5812-0500186
Compound: PF -07302048; Protocol: C4591001 Page 10of 16
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1007 10071581; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 17DEC2020; Date of Last Dose: 07JAN2021
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PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591 001_EUA_Narrative_Safety/profile Date of Generation: 01APR2021 (10:32)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2005 15 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
175 cm 64.8 kg 21.2 kg/m2 17DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
ADHD Attention deficit hyperactivity disorder 2012 Present
Migraine Migraine 2018 Present
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FDA-CBER-2022-5812-0500187
Compound: PF -07302048; Protocol: C4591001 Page 11of 16
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1007 10071581; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 17DEC2020; Date of Last Dose: 07JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm , vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Safety/profile Date of Generation: 01APR2021 (10:32)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 17DEC2020 (1) 15:49
2 Placebo 07JAN2021 (22) 15:49
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
Time
1 INFEC Appendicitis Appendicitis 11MAR2021 (85) ONGOING
Adverse Events
AE
NumberDuration
(Days)Toxicity
GradeAction
to
Subject SAEAE Still
Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 3 TC Y Yes NOT RELATED/OTHER: Infection 2 64 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vacci nes
090177e196b13481\Final\Final On: 02-Apr-2021 08:33 (GMT)
Page 11
FDA-CBER-2022-5812-0500188
Compound: PF -07302048; Protocol: C4591001 Page 12of 16
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1007 10071581; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 17DEC2020; Date of Last Dose: 07JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Safety/profile Date of Generation: 01APR2021 (10:32)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 17DEC2020
Completed VACCINATION 04FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
Narrative Comment
Subject C4591001 1007 10071581, a 15-year-old white male with no pertinent medical history, received Dose 1 on 17 Dec2020 and Dose 2 on 07 Jan2021 (Day 22). The
subject was diagnosed with appendicitis on 11 Mar 2021, 63 days after receiving Dose 2.
On11Mar 2021 (Day 85), the subject presented to the emergency room with worsening of abdominal pain that localized to the right lower quadrant for a day. The subject
was subsequently hospitalized for nonoperative pain management. An abdominal ultrasound scan was consistent with acute appendicitis, and the appendix was visualized.
The subject remained afebrile while hospitalized. Relevant laboratory tests performed on the same day (Day 85) showed an elevated red blood cell count of 5.43 (normal
range [NR ]: 4.5 -5.3) and lymphocytes of 47.8 (NR: 34.0 -42.0); decreased segmented neutrophils of 39.9 (NR: 40.0-62.0); and normal white blood cell (WBC) count of 6.94
(NR: 4.5 -13.5), hemoglobin of 15.3 (NR: 13.0 -16.0), hematocrit of 44.9 (NR: 37.0 -49.0), and platelet count of 357 (NR: 135 -466) (units not reported for all the laboratory
values). A SARS -CoV -2 test performed on 11 Mar 2021 (Day 85) was negative. During hospitalization, the subject received a single dose of intravenous (IV) metronidazole
1000 mg and I V ceftriaxone 2000 mg, both on 11 Mar 2021 (Day 85). On 12 Mar 2020 (Day 86), the subject was discharged from the hospital on oral (PO) amoxicillin -
clavulanate 875/125 -mg tablet twice a day for 14 days, PO ibuprofen 600 mg every 6 hours as needed (PRN) fo r moderate pain, and PO acetaminophen 325 mg every 4 to
6 hours PRN for pain. The appendicitis was ongoing at the time of the last available report.
In the opinion of the investigator, there was no reasonable possibility that the appendicitis was relate d to the study intervention, concomitant medications, or clinical trial
procedures. Pfizer concurred with the investigator’s causality assessment.
090177e196b13481\Final\Final On: 02-Apr-2021 08:33 (GMT)
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FDA-CBER-2022-5812-0500189
Compound: PF -07302048; Protocol: C4591001 Page 13of 16
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1147 11471281; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 12DEC2020; Date of Last Dose: 04JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Safety/profile Date of Generation: 01APR2021 (10:32)Demography
Date of Birth Age at Enro llment (Years) Race Ethnicity Sex
2007 13 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
172.5 cm 67.65 kg 22.7 kg/m2 12DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Constipation Constipation 02JUL2014 Present
Perforation of right tympanic membrane Tympanic membrane perforation 02JUL2014 Present
Psoriasis Psoriasis 2016 Present
Other iron deficiency anemia Iron deficiency anaemia 27MAY2020 Present
090177e196b13481\Final\Final On: 02-Apr-2021 08:33 (GMT)
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(b) (6)
FDA-CBER-2022-5812-0500190
Compound: PF -07302048; Protocol: C4591001 Page 14of 16
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1147 11471281; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 12DEC2020; Date of Last Dose: 04JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Safety/profile Date of Generation: 01APR2021 (10:32)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 12DEC2020 (1) 10:44
2 Placebo 04JAN2021 (24) 16:37
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)Toxicity
Grade
1 INFEC Appendicitis Acute appendicitis 22JAN2021 (42) 16:00 23JAN2021 (43) 00:01 2 4
2 INFEC Focal peritonitis localized peritonitis, without
perforation or gangrene22JAN2021 (42) 16:00 23JAN2021 (43) 00:01 2 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 Y Resolved (23JAN2021) NOT RELATED/OTHER: Acute appendicitis 2 19 Y
2 TC/TCN Y Resolved (23JAN2021) NOT RELATED/OTHER: Acute appendicitis 2 19 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196b13481\Final\Final On: 02-Apr-2021 08:33 (GMT)
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FDA-CBER-2022-5812-0500191
Compound: PF -07302048; Protocol: C4591001 Page 15of 16
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1147 11471281; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 12DEC2020; Date of Last Dose: 04JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Safety/profile Date of Generation: 01APR2021 (10:32)Nonstudy Vaccines
No Nonstudy Vacci nes
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 12DEC2020
Completed VACCINATION 06FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b13481\Final\Final On: 02-Apr-2021 08:33 (GMT)
Page 15
FDA-CBER-2022-5812-0500192
Compound: PF -07302048; Protocol: C4591001 Page 16of 16
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1147 11471281; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 12DEC2020; Date of Last Dose: 04JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Safety/profile Date of Generation: 01APR2021 (10:32)Narrative Comment
Subject C4591001 1147 11471281, a 13-year-old white male with a pertinent medical history of constipation (since 02 Jul2014), psoriasis (since 2016), and iron deficiency
anemia (since 27 May 2020), received Dose 1 on 12 Dec2020 and Dose 2 on 04 Jan2021 (Day 24). The subject was diagnos ed with appendicitis and focal peritonitis on
22Jan2021, 18 days after receiving Dose 2.
Concomitant medications included polyethylene glycol (since 2013) for constipation, ferrous sulfate (since 27 May 2020) for iron deficiency anemia, and mupirocin (si nce
22Dec2020) for psoriasis.
On 22 Jan2021 (Day 42), the subject presented to the emergency room (ER) with localized acute abdominal pain in the right lower quadrant within 5 hours after the onset. It
was reported that the abdominal pain was associa ted with anorexia. The subject was tachycardic on arrival to the ER, and the right lower quadrant was focally tender. The
laboratory tests showed an elevated white blood cell count of 18.63 × 103/mm3 (normal range [NR]: 3.90- 12.70 ×103/mm3), and an ultrasound scan of the abdomen was
consistent with acute appendicitis with lower right quadrant pain; no findings were suggestive of appendiceal perforation. A serious adverse event of focal peritonitis
(localized peritonitis without perforation or gangrene) was also reported with an onset date of 22 Jan2021 (Day 42). Other relevant tests included an elevated absolute
neutrophil count of 16 ×103/mm3 (NR: 1.8 -7.7× 103/mm3) and granulocytes of 85.8% (NR: 38%- 73%); decreased lymphocytes of 7.4% (NR: 18% -48%); and immature
granulocyte count of 0.07 ×103/mm3 (NR: 0.0 -0.5×103/mm3) and monocyte count of 0.9 ×103/mm3 (NR: 0.3 -1.0× 103/mm3). The subject received unspecified
intravenous (IV) fluids and immediately had a laparoscopic appendectomy procedure, whic h was reported to be well tolerated. On 23 Jan2021 (Day 43), the appendicitis and
focal peritonitis resolved, and the subject was discharged from the hospital. The appendicitis and focal peritonitis were co nsidered as life -threatening events by the
investigator.
In the opinion of the investigator, there was no reasonable possibility that the appendicitis and focal peritonitis were rela ted to the study intervention, concomitant
medications, or clinical trial procedures. Pfizer concurred with the investig ator’s causality assessment.
090177e196b13481\Final\Final On: 02-Apr-2021 08:33 (GMT)
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FDA-CBER-2022-5812-0500193
Compound: PF -07302048; Protocol: C4591001 Page 1of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1007 10071497; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 02DEC2020; Date of Last Dose: 22DEC2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age a t Enrollment (Years) Race Ethnicity Sex
2008 12 Asian Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
151 cm 39 kg 17.1 kg/m2 02DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Attention deficit/hyperactivity disorder Attention deficit hyperactivity disorder 2017 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 02DEC2020 (1) 17:22
2 BNT162b2 22DEC2020 (21) 09:50
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 17
(b) (6)
FDA-CBER-2022-5812-0500194
Compound: PF -07302048; Protocol: C4591001 Page 2of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1007 10071497; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 02DEC2020; Date of Last Dose: 22DEC2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)
1 BLOOD Lymphadenopathy swollen lymph node left axilla 25DEC2020 (24) ONGOING
Adverse Events
AE
NumberStop
TimeDuration
(Days)Toxicity
GradeAction
to
Subject SAEAE Still
Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 1 N N Yes Study Treatment 2 4 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 18
FDA-CBER-2022-5812-0500195
Compound: PF -07302048; Protocol: C4591001 Page 3of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1007 10071497; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 02DEC2020; Date of Last Dose: 22DEC2020
==========================================================================================================================
PFIZE R CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 02DEC2020
Completed VACCINATION 20JAN2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 19
FDA-CBER-2022-5812-0500196
Compound: PF -07302048; Protocol: C4591001 Page 4of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1007 10071615; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 29DEC2020; Date of Last Dose: 19JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2008 12 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
155 cm 45.9 kg 19.1 kg/m2 29DEC2020 (1)
Medical History
No Medical History
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 29DEC2020 (1) 16:12
2 BNT162b2 19JAN2021 (22) 16:34
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 20
(b) (6)
FDA-CBER-2022-5812-0500197
Compound: PF -07302048; Protocol: C4591001 Page 5of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1007 10071615; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 29DEC2020; Date of Last Dose: 19JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
Time
1 BLOOD Lymphadenopathy left axillary lymph node swelling 20JAN2021 (23) 23JAN2021 (26)
Adverse Events
AE
NumberDuration
(Days)Toxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 4 1 N N Resolved (23JAN2021) Study Treatment 2 2 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 21
FDA-CBER-2022-5812-0500198
Compound: PF -07302048; Protocol: C4591001 Page 6of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1007 10071615; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 29DEC2020; Date of Last Dose: 19JAN2021
======================================================================================================================== ==
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 29DEC2020
Completed VACCINATION 23FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 22
FDA-CBER-2022-5812-0500199
Compound: PF-07302048; Protocol: C4591001 Page 7of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1007 10071651; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 05JAN2021; Date of Last Dose: 26JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2008 12 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
160 cm 44.6 kg 17.4 kg/m2 05JAN2021 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Penicillin allergy Drug hypersensitivity 01JAN2010 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 05JAN2021 (1) 10:55
2 BNT162b2 26JAN2021 (22) 10:48
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 23
(b) (6)
FDA-CBER-2022-5812-0500200
Compound: PF -07302048; Protocol: C4591001 Page 8of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1007 10071651; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 05JAN2021; Date of Last Dose: 26JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 2 5MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)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 BLOOD Lymphadenopathy Left deep cervical chain lymph
node swelling12JAN2021 (8) 12:30 09FEB2021
(36)29 1 N N
2 BLOOD Lymphadenopathy left Cervical lymphadenopathy 23FEB2021
(50)07:30 ONGOING 1 N N
Adverse Events
AE
Number AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 Resolved
(09FEB2021)Study Treatment 1 8 Y
2 Yes NOT RELATED/OTHER: Local adenopathy. Do not think
related to study agent2 29 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 24
FDA-CBER-2022-5812-0500201
Compound: PF -07302048; Protocol: C4591001 Page 9of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1007 10071651; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 05JAN2021; Date of Last Dose: 26JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 05JAN2021
Completed VACCINATION 23FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 25
FDA-CBER-2022-5812-0500202
Compound: PF-07302048; Protocol: C4591001 Page 10of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1009 10091231; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 20OCT2020; Date of Last Dose: 09NOV2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2005 15 Asian Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
167.64 cm 57.82 kg 20.5 kg/m2 20OCT2020 (1)
Medical History
No Medical History
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 20OCT2020 (1) 18:16
2 BNT162b2 09NOV2020 (21) 15:56
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 26
(b) (6)
FDA-CBER-2022-5812-0500203
Compound: PF -07302048; Protocol: C4591001 Page 11of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1009 10091231; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 20OCT2020; Date of Last Dose: 09NOV2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
Time
1 BLOOD Lymphadenopathy left swollen axillary lymph node 10NOV2020 (22) 10NOV2020 (22)
Adverse Events
AE
NumberDuration
(Days)Toxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 1 1 N N Resolved (10NOV2020) Study Treatment 2 2 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 27
FDA-CBER-2022-5812-0500204
Compound: PF -07302048; Protocol: C4591001 Page 12of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1009 10091231; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 20OCT2020; Date of Last Dose: 09NOV2020
======================================================================================================================== ==
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 20OCT2020
Completed VACCINATION 10DEC2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 28
FDA-CBER-2022-5812-0500205
Compound: PF-07302048; Protocol: C4591001 Page 13of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1009 10091342; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 14DEC2020; Date of Last Dose: 04JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2005 15 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
175.26 cm 61.64 kg 20 kg/m2 14DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Ketamine allergy Drug hypersensitivity 2007 Present
Allergic Rhinitis Rhinitis allergic 2007 Present
eczema, bilateral hands Hand dermatitis 2018 Present
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 29
(b) (6)
FDA-CBER-2022-5812-0500206
Compound: PF -07302048; Protocol: C4591001 Page 14of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1009 10091342; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 14DEC2020; Date of Last Dose: 04JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 14DEC2020 (1) 18:25
2 BNT162b2 04JAN2021 (22) 17:11
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 BLOOD Lymphadenopathy swollen cervical lymph nodes
bilateral31JAN2021 (49) 02FEB2021 (51) 3
Adverse Events
AE
NumberToxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 1 N N Resolved (02FEB2021) NOT RELATED/OTHER: unknown 2 28 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 30
FDA-CBER-2022-5812-0500207
Compound: PF -07302048; Protocol: C4591001 Page 15of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1009 10091342; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 14DEC2020; Date of Last Dose: 04JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 14DEC2020
Completed VACCINATION 05FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 31
FDA-CBER-2022-5812-0500208
Compound: PF -07302048; Protocol: C4591001 Page 16of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1016 10161344; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 22OCT2020; Date of Last Dose: 11NOV2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2005 15 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
152.4 cm 51.36 kg 22.1 kg/m2 22OCT2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
seasonal allergies Seasonal allergy FEB2010 Present
attention deficit disorder Attention deficit hyperactivity disorder SEP2014 Present
hypotension Hypotension MAY2017 Present
acne Acne JUN2017 Present
anxiety Anxiety AUG2017 Present
anger disorder Anger NOV2018 Past
oppositional defiance disorder Oppositional defiant disorder NOV2018 Past
moderate depression Depression MAY2019 Present
chronic vocal tic disorder Chronic tic disorder 01MAY2020 Present
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 32
(b) (6)
FDA-CBER-2022-5812-0500209
Compound: PF -07302048; Protocol: C4591001 Page 17of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1016 10161344; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 22OCT2020; Date of Last Dose: 11NOV2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C459 1001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 22OCT2020 (1) 16:44
2 Placebo 11NOV2020 (21) 15:37
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 INFEC Infectious mononucleosis infectious mononuclesosis 25NOV2020 (35) 06JAN2021 (77) 43
2 BLOOD Lymphadenopathy enlarged lymph nodes, right
anterior cervical nodes25NOV2020 (35) 06JAN2021 (77) 43
Adverse Events
AE
NumberToxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 1 N N Resolved (06JAN2021) NOT RELATED/OTHER: mono infection 2 15 N
2 1 N N Resolved (06JAN2021) NOT RELATED/OTHER: mono 2 15 Y
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 33
FDA-CBER-2022-5812-0500210
Compound: PF -07302048; Protocol: C4591001 Page 18of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1016 10161344; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 22OCT2020; Date of Last Dose: 11NOV2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)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
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 34
FDA-CBER-2022-5812-0500211
Compound: PF -07302048; Protocol: C4591001 Page 19of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1126 11261263; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 04DEC2020; Date of Last Dose: 23DEC2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2005 15 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
169 cm 55 kg 19.3 kg/m2 04DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Laparoscopic Appendectomy Appendicectomy 26OCT2016 Past
Appendicitis Appendicitis 26OCT2016 Past
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 35
(b) (6)
FDA-CBER-2022-5812-0500212
Compound: PF -07302048; Protocol: C4591001 Page 20of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1126 11261263; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 04DEC2020; Date of Last Dose: 23DEC2020
=================================================================================================================== =======
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 04DEC2020 (1) 16:51
2 BNT162b2 23DEC2020 (20) 15:39
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)Toxicity
Grade
1 INJ&P Fall Mechanical Fall 20DEC2020 (17) 20DEC2020 (17) 1 2
2 BLOOD Lymphadenopathy LEFT AXILLA LYMPH NODE
SWELLING10DEC2020 (7) 13DEC2020 (10) 4 1
3 INJ&P Radius fracture RIGHT DISTAL RADIUS
TORUS FRACTURE20DEC2020 (17) 20JAN2021 (48) 32 2
Adverse Events
AE
NumberAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 N N Resolved (20DEC2020) NOT RELATED/OTHER: Snow boarding 1 17 N
2 N N Resolved (13DEC2020) Study Treatment 1 7 Y
3 TC N Resolved (20JAN2021) NOT RELATED/OTHER: MECHANICAL FALL 1 17 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 36
FDA-CBER-2022-5812-0500213
Compound: PF -07302048; Protocol: C4591001 Page 21of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1126 11261263; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 04DEC2020; Date of Last Dose: 23DEC2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 04DEC2020
Completed VACCINATION 20JAN2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 37
FDA-CBER-2022-5812-0500214
Compound: PF -07302048; Protocol: C4591001 Page 22of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1131 11311287; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 29DEC2020; Date of Last Dose: 18JAN2021
=============================================================================== ===========================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2008 12 Black or African American Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
156.3 cm 47.5 kg 19.4 kg/m2 29DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
attention deficit hyperactivity disorder Attention deficit hyperactivity disorder 2016 Present
eczema Eczema 2019 Present
acne Acne APR2020 Present
depressive symptoms Depressive symptom OCT2020 Present
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 38
(b) (6)
FDA-CBER-2022-5812-0500215
Compound: PF -07302048; Protocol: C4591001 Page 23of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1131 11311287; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 29DEC2020; Date of Last Dose: 18JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C459 1001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 29DEC2020 (1) 11:35
2 Placebo 18JAN2021 (21) 13:20
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)Toxicity
Grade
1 BLOOD Lymphadenopathy enlarge lymph nods -
neck(bilateral)27JAN2021 (30) 03FEB2021 (37) 8 1
2 RESP Rhinorrhoea rhinorrhea 17JAN2021 (20) 03FEB2021 (37) 18 1
Adverse Events
AE
NumberAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 N N Resolved (03FEB2021) Study Treatment 2 10 Y
2 N N Resolved (03FEB2021) NOT RELATED/OTHER: unknown viral exposure 1 20 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 39
FDA-CBER-2022-5812-0500216
Compound: PF -07302048; Protocol: C4591001 Page 24of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1131 11311287; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 29DEC2020; Date of Last Dose: 18JAN2021
===================================================== =====================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 29DEC2020
Completed VACCINATION 15FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 40
FDA-CBER-2022-5812-0500217
Compound: PF -07302048; Protocol: C4591001 Page 25of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1142 11421385; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 31DEC2020; Date of Last Dose: 22JAN2021
======================================================================================================================== ==
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2005 15 Not Reported Hispanic/Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
170.18 cm 65.82 kg 22.7 kg/m2 31DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
mild asthma Asthma 2007 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 31DEC2020 (1) 10:42
2 BNT162b2 22JAN2021 (23) 09:57
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 41
(b) (6)
FDA-CBER-2022-5812-0500218
Compound: PF -07302048; Protocol: C4591001 Page 26of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1142 11421385; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 31DEC2020; Date of Last Dose: 22JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Sourc e Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)
1 BLOOD Lymphadenopathy left supraclavicular lymph node
swelling07JAN2021 (8) ONGOING
Adverse Events
AE
NumberStop
TimeDuration
(Days)Toxicity
GradeAction
to
Subject SAEAE Still
Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 1 N N Yes Study Treatment 1 8 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 42
FDA-CBER-2022-5812-0500219
Compound: PF -07302048; Protocol: C4591001 Page 27of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1142 11421385; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 31DEC2020; Date of Last Dose: 22JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 31DEC2020
Completed VACCINATION 22FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 43
FDA-CBER-2022-5812-0500220
Compound: PF-07302048; Protocol: C4591001 Page 28of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1152 11521683; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 15DEC2020; Date of Last Dose: 05JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2006 14 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
170.18 cm 52.18 kg 18 kg/m2 15DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
myopia Myopia 2015 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 15DEC2020 (1) 17:06
2 BNT162b2 05JAN2021 (22) 15:56
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 44
(b) (6)
FDA-CBER-2022-5812-0500221
Compound: PF -07302048; Protocol: C4591001 Page 29of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1152 11521683; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 15DEC2020; Date of Last Dose: 05JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)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 BLOOD Lymphadenopathy Swollen Lymph Node (Left
Clavicle)26DEC2020 (12) ONGOING 1 N N
Adverse Events
AE
NumberAE Still
Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 Yes NOT RELATED/OTHER: Mild swollen lymph node from probable microbial infection, per investigator.
NCS1 12 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 45
FDA-CBER-2022-5812-0500222
Compound: PF -07302048; Protocol: C4591001 Page 30of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1152 11521683; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 15DEC2020; Date of Last Dose: 05JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C459 1001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 15DEC2020
Completed VACCINATION 02FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 46
FDA-CBER-2022-5812-0500223
Compound: PF -07302048; Protocol: C4591001 Page 31of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1152 11521704; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 21DEC2020; Date of Last Dose: 11JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2006 14 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
167.64 cm 50.64 kg 18 kg/m2 21DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
allergy to bee stings Allergy to arthropod sting 2016 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 21DEC2020 (1) 11:21
2 BNT162b2 11JAN2021 (22) 11:58
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 47
(b) (6)
FDA-CBER-2022-5812-0500224
Compound: PF -07302048; Protocol: C4591001 Page 32of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1152 11521704; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 21DEC2020; Date of Last Dose: 11JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 2 5MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
Time
1 BLOOD Lymphadenopathy swollen lymph node left axilla 26DEC2020 (6) 04JAN2021 (15)
Adverse Events
AE
NumberDuration
(Days)Toxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 10 2 N N Resolved (04JAN2021) Study Treatment 1 6 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 48
FDA-CBER-2022-5812-0500225
Compound: PF -07302048; Protocol: C4591001 Page 33of 46
Reason(s) for Narrative: Lymphadenopathy
Unique Subject ID: C4591001 1152 11521704; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 21DEC2020; Date of Last Dose: 11JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C459 1001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 21DEC2020
Completed VACCINATION 08FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 49
FDA-CBER-2022-5812-0500226
Compound: PF -07302048; Protocol: C4591001 Page 34of 46
Reason(s) for Narrative: Other SAE
Unique Subject ID: C4591001 1007 10071620; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 30DEC2020; Date of Last Dose: 20JAN2021
======================================================================================================================== ==
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2008 12 White Hispanic/Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
155.5 cm 57.1 kg 23.6 kg/m2 30DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Attention deficit disorder Attention deficit hyperactivity disorder 2018 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 30DEC2020 (1) 10:26
2 BNT162b2 20JAN2021 (22) 16:30
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 50
(b) (6)
FDA-CBER-2022-5812-0500227
Compound: PF -07302048; Protocol: C4591001 Page 35of 46
Reason(s) for Narrative: Other SAE
Unique Subject ID: C4591001 1007 10071620; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 30DEC2020; Date of Last Dose: 20JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C459 1001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)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 GASTR Abdominal pain Abdominal pain 21JAN2021 (23) 09FEB2021 (42) 20 2 TC N
2 GASTR Abdominal pain Functional Abdominal Pain 28FEB2021 (61) ONGOING 3 TC Y
3 GASTR Constipation Constipation 28FEB2021 (61) ONGOING 3 TC Y
4 SKIN Dermatitis contact contact dermatitis bilateral arms 12FEB2021 (45) ONGOING 1 TC N
5 GASTR Gastritis Gastritis 30JAN2021 (32) ONGOING 2 TC N
6 NERV Neuralgia generalized Functional neurologic
pain21JAN2021 (23) ONGOING 2 TC Y
7 INFEC Vulval abscess Vulvar boil 24JAN2021 (26) 26JAN2021 (28) 3 1 TC N
Adverse Events
AE
Number AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 Resolved
(09FEB2021)Study Treatment 2 2 N
2 Yes NOT RELATED/OTHER: no organic cause; no known
precipitating factors2 40 Y
3 Yes NOT RELATED/OTHER: no organic cause identified 2 40 Y
4 Yes NOT RELATED/OTHER: suspected reaction to tape 2 24 N
5 Yes NOT RELATED/CONCOMITANT DRUG TREATMENT 2 11 N
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 51
FDA-CBER-2022-5812-0500228
Compound: PF -07302048; Protocol: C4591001 Page 36of 46
Reason(s) for Narrative: Other SAE
Unique Subject ID: C4591001 1007 10071620; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 30DEC2020; Date of Last Dose: 20JAN2021
====================================================================================== ====================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Adverse Events
AE
Number AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
6 Yes NOT RELATED/OTHER: unspecified 2 2 Y
7 Resolved
(26JAN2021)NOT RELATED/OTHER: Presumed staph infection 2 5 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstu dy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 30DEC2020
Completed VACCINATION 18FEB2021
REPEAT SCREENING 1
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 52
FDA-CBER-2022-5812-0500229
Compound: PF -07302048; Protocol: C4591001 Page 37of 46
Reason(s) for Narrative: Other SAE
Unique Subject ID: C4591001 1007 10071620; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 30DEC2020; Date of Last Dose: 20JAN2021
==========================================================================================================================
PFIZE R CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 53
FDA-CBER-2022-5812-0500230
Compound: PF -07302048; Protocol: C4591001 Page 38of 46
Reason(s) for Narrative: Other SAE
Unique Subject ID: C4591001 1039 10391326; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 11JAN2021; Date of Last Dose: 01FEB2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2005 15 Asian Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
177.7 cm 65.5 kg 20.7 kg/m2 11JAN2021 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
asthma Asthma 2006 Past
glasses user Corrective lens user 2012 Present
seasonal allergic rhinitis Seasonal allergy 2016 Present
anxiety Anxiety 2018 Present
attention deficit hyperactivity disorder Attention deficit hyperactivity disorder 2018 Present
Depression Depression 2018 Present
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 54
(b) (6)
FDA-CBER-2022-5812-0500231
Compound: PF-07302048; Protocol: C4591001 Page 39of 46
Reason(s) for Narrative: Other SAE
Unique Subject ID: C4591001 1039 10391326; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 11JAN2021; Date of Last Dose: 01FEB2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_un blinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 11JAN2021 (1) 12:50
2 BNT162b2 01FEB2021 (22) 08:31
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 PSYCH Depression Depression Exacerbation 26JAN2021 (16) 30JAN2021 (20) 5
Adverse Events
AE
NumberToxicity
GradeAction to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 3 TC/TCN Y Resolved (30JAN2021) NOT RELATED/OTHER: Stress 1 16 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 55
FDA-CBER-2022-5812-0500232
Compound: PF -07302048; Protocol: C4591001 Page 40of 46
Reason(s) for Narrative: Other SAE
Unique Subject ID: C4591001 1039 10391326; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 11JAN2021; Date of Last Dose: 01FEB2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Nonstudy Vaccines
No Nonstu dy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 11JAN2021
Completed VACCINATION 04MAR2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 56
FDA-CBER-2022-5812-0500233
Compound: PF-07302048; Protocol: C4591001 Page 41of 46
Reason(s) for Narrative: Other SAE
Unique Subject ID: C4591001 1123 11231507; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 28DEC2020; Date of Last Dose: 18JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2006 14 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
162.5 cm 50.7 kg 19.2 kg/m2 28DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Seasonal allergies Seasonal allergy 2008 Present
Attention deficit hyperactive disorder Attention deficit hyperactivity disorder 2013 Present
Migraines Migraine 2015 Present
Anxiety Anxiety OCT2018 Present
Depression Depression OCT2018 Present
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 57
(b) (6)
FDA-CBER-2022-5812-0500234
Compound: PF -07302048; Protocol: C4591001 Page 42of 46
Reason(s) for Narrative: Other SAE
Unique Subject ID: C4591001 1123 11231507; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 28DEC2020; Date of Last Dose: 18JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm , ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 28DEC2020 (1) 16:52
2 BNT162b2 18JAN2021 (22) 11:50
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 PSYCH Depression Worsening of Depression 19JAN2021 (23) 23JAN2021 (27) 5
Adverse Events
AE
NumberToxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 2 TC Y Resolved (23JAN2021) NOT RELATED/OTHER: unknown 2 2 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 58
FDA-CBER-2022-5812-0500235
Compound: PF -07302048; Protocol: C4591001 Page 43of 46
Reason(s) for Narrative: Other SAE
Unique Subject ID: C4591001 1123 11231507; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 28DEC2020; Date of Last Dose: 18JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 28DEC2020
Completed VACCINATION 16FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 59
FDA-CBER-2022-5812-0500236
Compound: PF -07302048; Protocol: C4591001 Page 44of 46
Reason(s) for Narrative: Other SAE
Unique Subject ID: C4591001 1270 12701222; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 18DEC2020; Date of Last Dose: 08JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2006 14 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
167.6 cm 60.6 kg 21.6 kg/m2 18DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Attention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorder JAN2015 Present
Right knee pain Arthralgia 19JUN2020 Present
Right Forearm Pain Pain in extremity 19JUN2020 Present
Anxiety Anxiety 31AUG2020 Present
Depression Depression 08DEC2020 Present
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 60
(b) (6)
FDA-CBER-2022-5812-0500237
Compound: PF -07302048; Protocol: C4591001 Page 45of 46
Reason(s) for Narrative: Other SAE
Unique Subject ID: C4591001 1270 12701222; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 18DEC2020; Date of Last Dose: 08JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Dat a: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 18DEC2020 (1) 16:30
2 BNT162b2 08JAN2021 (22) 14:18
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 PSYCH Suicidal ideation SUICIDAL IDEATION 16FEB2021 (61) 10:17 ONGOING
Adverse Events
AE
NumberToxicity
GradeAction
to
Subject SAEAE Still
Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 3 TCN Y Yes NOT RELATED/OTHER: PSYCHOSOCIAL ISSUES 2 40 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstu dy Vaccines
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 61
FDA-CBER-2022-5812-0500238
Compound: PF -07302048; Protocol: C4591001 Page 46of 46
Reason(s) for Narrative: Other SAE
Unique Subject ID: C4591001 1270 12701222; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 18DEC2020; Date of Last Dose: 08JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Other_AEI_SAE/profile Date of Generation: 01APR2021 (10:31)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 18DEC2020
Completed VACCINATION 05FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b1347f\Final\Final On: 02-Apr-2021 08:34 (GMT)
Page 62
FDA-CBER-2022-5812-0500239
Compound: PF -07302048; Protocol: C4591001 Page 1of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1006 10061245; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 10DEC2020; Date of Last Dose: 29DEC2020
======================================================================================================= ===================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2005 15 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
162.56 cm 49.36 kg 18.6 kg/m2 10DEC2020 (1)
Medical History
No Medical History
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 10DEC2020 (1) 12:11
2 Placebo 29DEC2020 (20) 11:37
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
Page 63
(b) (6)
FDA-CBER-2022-5812-0500240
Compound: PF -07302048; Protocol: C4591001 Page 2of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1006 10061245; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 10DEC2020; Date of Last Dose: 29DEC2020
======= ===================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_E UA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
Time
1 SKIN Urticaria Hives face 12DEC2020 (3) 31DEC2020 (22)
2 SKIN Urticaria Hives trunk 12DEC2020 (3) 15DEC2020 (6)
Adverse Events
AE
NumberDuration
(Days)Toxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 20 1 TC N Resolved (31DEC2020) Study Treatment 1 3 Y
2 4 1 TC N Resolved (15DEC2020) Study Treatment 1 3 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
Page 64
FDA-CBER-2022-5812-0500241
Compound: PF -07302048; Protocol: C4591001 Page 3of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1006 10061245; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 10DEC2020; Date of Last Dose: 29DEC2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 10DEC2020
Completed VACCINATION 26JAN2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
Page 65
FDA-CBER-2022-5812-0500242
Compound: PF -07302048; Protocol: C4591001 Page 4of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1007 10071585; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 17DEC2020; Date of Last Dose: 07JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, m h, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2008 12 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
168 cm 89.4 kg 31.7 kg/m2 17DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
ADHD, predominantly inattentive type Attention deficit hyperactivity disorder 2018 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 17DEC2020 (1) 16:27
2 Placebo 07JAN2021 (22) 15:58
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
Page 66
(b) (6)
FDA-CBER-2022-5812-0500243
Compound: PF -07302048; Protocol: C4591001 Page 5of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1007 10071585; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 17DEC2020; Date of Last Dose: 07JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C45 91001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)
1 SKIN Urticaria hives; trunk, abdomen, back 16JAN2021 (31) ONGOING
Adverse Events
AE
NumberStop
TimeDuration
(Days)Toxicity
GradeAction
to
Subject SAEAE Still
Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 2 TC N Yes Study Treatment 2 10 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
Page 67
FDA-CBER-2022-5812-0500244
Compound: PF -07302048; Protocol: C4591001 Page 6of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1007 10071585; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 17DEC2020; Date of Last Dose: 07JAN2021
======= ===================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 17DEC2020
Completed VACCINATION 04FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
Page 68
FDA-CBER-2022-5812-0500245
Compound: PF -07302048; Protocol: C4591001 Page 7of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1008 10081928; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 08JAN2021; Date of Last Dose: 29JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C45 91001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2007 13 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
163.83 cm 74.09 kg 27.5 kg/m2 08JAN2021 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Sulfa allergy Drug hypersensitivity 2014 Present
Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder 2016 Present
Anxiety Anxiety 2018 Present
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
Page 69
(b) (6)
FDA-CBER-2022-5812-0500246
Compound: PF -07302048; Protocol: C4591001 Page 8of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1008 10081928; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 08JAN2021; Date of Last Dose: 29JAN2021
========================================================================================================== ================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 08JAN2021 (1) 15:23
2 BNT162b2 29JAN2021 (22) 14:26
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
Time
1 SKIN Urticaria urticaria multiple sites 10JAN2021 (3) 22JAN2021 (15)
Adverse Events
AE
NumberDuration
(Days)Toxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 13 1 TC N Resolved (22JAN2021) Study Treatment 1 3 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
Page 70
FDA-CBER-2022-5812-0500247
Compound: PF -07302048; Protocol: C4591001 Page 9of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1008 10081928; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 08JAN2021; Date of Last Dose: 29JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 08JAN2021
Completed VACCINATION 26FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
Page 71
FDA-CBER-2022-5812-0500248
Compound: PF -07302048; Protocol: C4591001 Page 10of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1039 10391337; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 12JAN2021; Date of Last Dose: 03FEB2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2005 15 White Hispanic/Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
182.4 cm 84.7 kg 25.5 kg/m2 12JAN2021 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
penicillin allergy Drug hypersensitivity 2007 Present
recurrent diarrhea Diarrhoea 2010 Present
tonsillectomy Tonsillectomy 2011 Past
eczema, bilateral arms Eczema 2012 Past
acne Acne 2018 Present
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
Page 72
(b) (6)
FDA-CBER-2022-5812-0500249
Compound: PF -07302048; Protocol: C4591001 Page 11of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1039 10391337; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 12JAN2021; Date of Last Dose: 03FEB2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 12JAN2021 (1) 12:09
2 Placebo 03FEB2021 (23) 07:51
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
Time
1 SKIN Urticaria urticaria, both hands 04FEB2021 (24) 06FEB2021 (26)
Adverse Events
AE
NumberDuration
(Days)Toxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 3 1 N N Resolved (06FEB2021) Study Treatment 2 2 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
Page 73
FDA-CBER-2022-5812-0500250
Compound: PF -07302048; Protocol: C4591001 Page 12of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1039 10391337; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 12JAN2021; Date of Last Dose: 03FEB2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C45 91001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 12JAN2021
Completed VACCINATION 09MAR2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
Page 74
FDA-CBER-2022-5812-0500251
Compound: PF -07302048; Protocol: C4591001 Page 13of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1044 10441373; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 12JAN2021; Date of Last Dose: 04FEB2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, m h, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2006 14 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
156.2 cm 43.9 kg 18 kg/m2 12JAN2021 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
GERD Gastrooesophageal reflux disease 2006 Present
Allergic Rhinitis Rhinitis allergic 2011 Present
anxiety Anxiety 2018 Present
Obsessive -compulsive disorder Obsessive -compulsive disorder 2020 Present
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
Page 75
(b) (6)
FDA-CBER-2022-5812-0500252
Compound: PF -07302048; Protocol: C4591001 Page 14of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1044 10441373; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 12JAN2021; Date of Last Dose: 04FEB2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 12JAN2021 (1) 10:33
2 Placebo 04FEB2021 (24) 10:04
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)Toxicity
Grade
1 PSYCH Anxiety Worsening of Anxiety 05MAR2021 (53) ONGOING 2
2 SKIN Urticaria hives forehead 12JAN2021 (1) 11:29 12JAN2021 (1) 1 1
Adverse Events
AE
NumberAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 TC N Yes NOT RELATED/OTHER: medication dosage adjustment 2 30 N
2 N N Resolved (12JAN2021) Study Treatment 1 1 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
Page 76
FDA-CBER-2022-5812-0500253
Compound: PF -07302048; Protocol: C4591001 Page 15of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1044 10441373; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 12JAN2021; Date of Last Dose: 04FEB2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, m h, ex, ae, cm, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 12JAN2021
Completed VACCINATION 09MAR2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
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FDA-CBER-2022-5812-0500254
Compound: PF -07302048; Protocol: C4591001 Page 16of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1126 11261268; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 14DEC2020; Date of Last Dose: 05JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_unblinded/C45 91001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2007 13 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
140.6 cm 33 kg 16.7 kg/m2 14DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Premenarchal Premenarche 2007 Present
Allergy to Bee Venom Allergy to arthropod sting 07OCT2010 Present
Urticaria, No Known Triggers Urticaria 07OCT2010 Present
Left Proximal Radius Fracture Radius fracture 27JUL2012 Past
Verruca Vulgaris Skin papilloma 09NOV2017 Present
Juvenile Osteochondrosis of Right Tarsal Osteochondrosis 25JUN2020 Present
Right Hip Flexor Strain Muscle strain 12NOV2020 Present
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(b) (6)
(b) (6)
FDA-CBER-2022-5812-0500255
Compound: PF -07302048; Protocol: C4591001 Page 17of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1126 11261268; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 14DEC2020; Date of Last Dose: 05JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, c m, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 14DEC2020 (1) 11:08
2 BNT162b2 05JAN2021 (23) 16:05
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 MUSC Osteochondrosis Juvenile Osteochondrosis of
bilateral fifth metatarsals28DEC2020 (15) ONGOING
2 SKIN Urticaria Facial Urticaria, worsening 18DEC2020 (5) 31DEC2020 (18) 14
Adverse Events
AE
NumberToxicity
GradeAction to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 2 TC/TCN N Yes NOT RELATED/OTHER: Gymnastic injury 1 15 N
2 1 N N Resolved (31DEC2020) NOT RELATED/OTHER: Trigger unknown 1 5 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
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FDA-CBER-2022-5812-0500256
Compound: PF -07302048; Protocol: C4591001 Page 18of 18
Reason(s) for Narrative: Adverse Events With Numerical Imbalance Between Vaccine Groups
Unique Subject ID: C4591001 1126 11261268; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 14DEC2020; Date of Last Dose: 05JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output
File: ./nda2_un blinded/C4591001_EUA_Narrative_Num_Imbalance/profile Date of Generation: 06APR2021 (22:17)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 14DEC2020
Completed VACCINATION 05FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b84462\Final\Final On: 07-Apr-2021 05:43 (GMT)
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FDA-CBER-2022-5812-0500257
Compound: PF -07302048; Protocol: C4591001 Page 1of 9
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 07JAN2021; Date of Last Dose: 07JAN2021
==========================================================================================================================
PFIZER CONFID ENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce, ho, pr, lb, mo, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_COVID/profile Date of Generation: 01APR2021 (10:33)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2007 13 American Indian or Alaska
NativeHispanic/Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
160 cm 69.7 kg 27.2 kg/m2 07JAN2021 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Depression Depression 02DEC2014 Present
Asthma Asthma 01FEB2016 Present
Anxiety Anxiety 23AUG2019 Present
Vitamin D Deficiency Vitamin D deficiency 22JUN2020 Present
Bilateral temporomandibular joint pain Temporomandibular joint syndrome 16NOV2020 Present
Right foot pain Pain in extremity 18DEC2020 Present
Allergy to Vancomycins Drug hypersensitivity 30DEC2020 Present
Pectus Carinatum Pectus carinatum 30DEC2020 Present
090177e196b13480\Final\Final On: 02-Apr-2021 08:33 (GMT)
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(b) (6)
FDA-CBER-2022-5812-0500258
Compound: PF -07302048; Protocol: C4591001 Page 2of 9
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 07JAN2021; Date of Last Dose: 07JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, pr, lb, mo, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_COVID/profile Date of Generation: 01APR2021 (10:33)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 07JAN2021 (1) 09:43
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 MUSC Musculoskeletal chest pain Rib pain on right side 10FEB2021 (35) 10MAR2021 (63) 29
Adverse Events
AE
NumberToxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative Day
From Prior
VaccinationNarrative
Event
1 1 N N Resolved (10MAR2021) NOT RELATED/OTHER: Unknown 1 35 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e196b13480\Final\Final On: 02-Apr-2021 08:33 (GMT)
Page 82
FDA-CBER-2022-5812-0500259
Compound: PF -07302048; Protocol: C4591001 Page 3of 9
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 07JAN2021; Date of Last Dose: 07JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, pr, lb, mo, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_COVID/profile Date of Generation: 01APR2021 (10:33)Nonstudy Vaccines
Investigator Text WHO Drug Preferred Term Start Date
Fluarix Quadrivalent (Influenza Vaccine) INFLUENZA VACCINE INACT SPLIT 4V 21DEC2020
SARS -COV -2 Baseline Tests -Central Laboratory
VisitVisit Date
(Study Day)Date of Collection
(Study Day)Specimen
TypeTest
Result
Visit 1 07JAN2021 (1) 07JAN2021 (1) NASAL_SWAB POSITIVE
Visit 1 07JAN2021 (1) 07JAN2021 (1) SERUM NEGATIVE
Visit 2 17FEB2021 (42) 17FEB2021 (42) NASAL_SWAB POSITIVE
Case Details
Visit>7 Days After
Dose 2 Severe
COVID Illness Visit 1 No No
COVID Illness Visit 2 No No
090177e196b13480\Final\Final On: 02-Apr-2021 08:33 (GMT)
Page 83
FDA-CBER-2022-5812-0500260
Compound: PF -07302048; Protocol: C4591001 Page 4of 9
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 07JAN2021; Date of Last Dose: 07JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, pr, lb, mo, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_COVID/profile Date of Generation: 01APR2021 (10:33)Signs and Symptoms of Potential COVID -19
Visit/
Visit Date or Date of
Assessment (Study Day)/
Date First Symptom
Started (Study Day)/
Date Last Symptom
Resolved (Study Day) or
Ongoing Prespecified EventSymptoms (Prespecified and
Others) MedDRA Preferred Term
COVID Illness Visit 1
/ 20JAN2021 (14)/
19JA N2021 (13)/
20JAN2021 (14)YES NEW OR INCREASED
SHORTNESS OF BREATH
COVID Illness Visit 2
/ 29JAN2021 (23)/
26JAN2021 (20)/
26JAN2021 (20)YES DIARRHEA
Diagnosis of Potential COVID -19 Illness
VisitVisit Date (Study
Day)Respiratory
Illness
DiagnosisDate of
Diagnosis
(Study Day)Toxicity
GradeMedDRA
Preferred
Term
COVID Illness Visit 1 20JAN2021 (14) COVID 19 24JAN2021 (18) 1 COVID -19
090177e196b13480\Final\Final On: 02-Apr-2021 08:33 (GMT)
Page 84
FDA-CBER-2022-5812-0500261
Compound: PF -07302048; Protocol: C4591001 Page 5of 9
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 07JAN2021; Date of Last Dose: 07JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, pr, lb, mo, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_COVID/profile Date of Generation: 01APR2021 (10:33)SARS -COV -2 Test -Central Laboratory
Lab Test
Number VisitVisit Date
(Study Day)Date of Collection
(Study Day)Specimen
TypeTest
Result
1 COVID Illness Visit 1 20JAN2021 (14) 21JAN2021 (15) NASAL_SWAB_SELF POSITIVE
2 COVID Illness Visit 2 29JAN2021 (23) 29JAN2021 (23) NASAL_SWAB_SELF POSITIVE
SARS -COV -2 Test -Local Laboratory
Lab Test
Number VisitVisit Date
(Study Day)Date of Collection
(Study Day)Specimen
TypeSpecimen
Collection
Location
1 COVID Illness Visit 1 20JAN2021 (14) 24JAN2021 (18) SWABBED MATERIAL NASOPHARYNX
SARS -COV -2 Test -Local Laboratory
Lab Test
NumberTest
Result Comments/Findings/Details Trade NameTradename
Other (Specify)
1 POSITIVE OTHER SARS COV2 TEST CLIA CERT
LAB
090177e196b13480\Final\Final On: 02-Apr-2021 08:33 (GMT)
Page 85
FDA-CBER-2022-5812-0500262
Compound: PF -07302048; Protocol: C4591001 Page 6of 9
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 07JAN2021; Date of Last Dose: 07JAN2021
=============================================================================================== ===========================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, pr, lb, mo, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_COVID/profile Date of Gen eration: 01APR2021 (10:33)Health Care Utilization
VisitVisit Date
(Study Day)Physician, Healthcare Professional,
or Other Type of Practitioner
(Specify)Occurrence
of
Visits/ContactsNumber
of
Visits or
ContactsOther Type
of
Practitioner
(Specify)
COVID Illness Visit 1 20JAN2021 (14) EMERGENCY ROOM NO NA
OTHER NO NA
PRIMARY CARE PHYSICIAN NO NA
SPECIALIST NO NA
TELEPHONE CONSULTATION NO NA
URGENT CARE NO NA
COVID Illness Visit 2 29JAN2021 (23) EMERGENCY ROOM NO NA
OTHER NO NA
PRIMARY CARE PHYSICIAN NO NA
SPECIALIST NO NA
URGENT CARE NO NA
TELEPHONE CONSULTATION YES 1 NA
Hospitalization Details
No Hospitalization Details
Respiratory Treatment
No Respiratory Treatment
090177e196b13480\Final\Final On: 02-Apr-2021 08:33 (GMT)
Page 86
FDA-CBER-2022-5812-0500263
Compound: PF -07302048; Protocol: C4591001 Page 7of 9
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 07JAN2021; Date of Last Dose: 07JAN2021
=================================================================================================================== =======
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, pr, lb, mo, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_COVID/profile Date of Generation: 01APR2021 (10:33)Diagnosis of Significant Acute Renal, Hepatic or Neurological Dysfunction
No Diagnosis of Significant Acute Renal, Hepatic or Neurological Dysfunction
Laboratory Results -Clinical Chemistry
No Laboratory Results -Clinical Chemistry
Laboratory Results -Hematology
No Laboratory Results -Hematol ogy
Vital Signs -COVID -19
No Vital Signs -COVID -19
Oxygenation Parameters
No Oxygenation Parameters
090177e196b13480\Final\Final On: 02-Apr-2021 08:33 (GMT)
Page 87
FDA-CBER-2022-5812-0500264
Compound: PF -07302048; Protocol: C4591001 Page 8of 9
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 07JAN2021; Date of Last Dose: 07JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, pr, lb, mo, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_COVID/profile Date of Generation: 01APR2021 (10:33)Concomitant Medications -Vasopressors
No Concomitant Medications -Vasopressors
Imaging
No Imaging
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 07JAN2021
Withdrawn VACCINATION 26JAN2021 NO LONGER MEETS
ELIGIBILITY CRITERIA
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
090177e196b13480\Final\Final On: 02-Apr-2021 08:33 (GMT)
Page 88
FDA-CBER-2022-5812-0500265
Compound: PF -07302048; Protocol: C4591001 Page 9of 9
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 07JAN2021; Date of Last Dose: 07JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, pr, lb, mo, ds Output
File: ./nda2_unblinded/C4591001_EUA_Narrative_COVID/profile Date of Generation: 01APR2021 (10:33)Narrative Comment
Subject C4591001 1270 12701237, a 13-year-old American Indian or Alaska native female with a height of 160 cm, a weight of 69.7 kg, and a BMI of 27.2 kg/m2, received
Dose 1 on 07 Jan2021.
The subject had a reported medical history of depression (since 0 2Dec2014), asthma (since 01 Feb2016), anxiety (since 23 Aug 2019), vitamin D deficiency (since
22Jun2020), temporomandibular joint syndrome (since 16 Nov 2020), pain in extremity (right foot; since 18 Dec2020), and drug hypersensitivity (allergy to v ancomycin)
and pectus carinatum (both since 30 Dec2020).
The central laboratory SARS -CoV -2 NAAT results were positive at Visit 1 and Visit 2. The central laboratory N -binding antibody result was negative at Visit 1.
The subject experienced 2 protocol-d efined COVID -19 illnesses.
On 24 Jan2021 (Day 18), the subject was diagnosed with COVID -19 and reported new or increased shortness of breath, with the symptom starting on 19 Jan2021, 12 days
after receiving Dose 1; the symptom resolved on 20 Jan2021 (Da y14).
The central laboratory SARS -CoV -2 NAAT result at the time of the first COVID -19 illness on 21 Jan2021 (Day 15) was positive.
The local laboratory SARS -CoV -2 NAAT result at the time of the first COVID -19 illness on 24 Jan2021 (Day 18) was posit ive.
For the first COVID -19 illness, the subject did not have any contact with nonstudy healthcare personnel.
The subject reported diarrhea, with the symptom starting on 26 Jan2021, 19 days after receiving Dose 1; the symptom resolved on 26 Jan2021 (Day 20).
The central laboratory SARS -CoV -2 NAAT result at the time of the second COVID -19 illness on 29 Jan2021 (Day 23) was positive.
For the second COVID -19 illness, the subject had a telephone consultation (once).
The subject was discontinued from t he study intervention on 26 Jan2021 since she no longer met the eligibility criteria and remains in the study to be evaluated for safety,
immunogenicity, and efficacy.
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FDA-CBER-2022-5812-0500266