Document text
Compound: PF -07302048; Protocol: C4591001 Page 1of 65
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: . (.) Source Data: adsl Output File: ./nda2/C4591001 Narratives Abbr/profile D ate o f Generation: 15SEP2021
(12:45)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P Drug withdrawn (study intervention discontinued)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 nondrug treatment given
W Withdrawn from study
Toxicity Grade 1 Mild
2 Moderate
3 Severe
4 Life-threatening
System Organ Class BLOOD Blood and lymphatic system disorders
CARD Cardiac disorders
CONG Congenital, familial and genetic disorders
EAR Ear and labyrinth disorders
ENDO Endocrine disorders
EYE Eye disorders
GASTR Gastrointestinal disorders
GENRL General disorders and administration site conditions
HEPAT Hepatobiliary disorders
IMMUN Immune system disorders
INFEC Infections and infestations
INJ&P Injury poisoning and procedural complications
INV Investigations
METAB Metabolism and nutrition disorders
MUSC Musculoskeletal and connective tissue disorders
NEOPL Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NERV Nervous system disorders
PREG Pregnancy, puerperium and perinatal conditions
PSYCH Psychiatric disorders
RENAL Renal and urinary disorders
REPRO Reproductive system and breast disorders
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 1
FDA-CBER-2022-5812-0500102
Compound: PF -07302048; Protocol: C4591001 Page 2of 65
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: . (.) Source Data: adsl Output File: ./nda2/C4591001 Narratives Abbr/profile D ate of Generation: 15SEP2021
(12:45)Table of Abbreviations
Category Abbreviation Text
RESP Respiratory, thoracic and mediastinal disorders
SKIN Skin and subcutaneous tissue disorders
SOCCI Social circumstances
SURG Surgical and medical procedures
VASC Vascular disorders
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 2
FDA-CBER-2022-5812-0500103
Compound: PF -07302048; Protocol: C4591001 Page 3of 65
Reason(s) for Narrative: Related Serious Adverse Event; Appendicitis
Unique Subject ID: C4591001 1156 11561357; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021; Date of Last Dose: 07JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2008 12 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
160.5 cm 40.95 kg 15.9 kg/m2 07JAN2021 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
PREMENARCHAL Premenarche 2008 Present
REFRACTIVE AMBLYOPIA (RIGHT EYE) Refractive amblyopia 2014 Present
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 3
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0500104
Compound: PF -07302048; Protocol: C4591001 Page 4of 65
Reason(s) for Narrative: Related Serious Adverse Event; Appendicitis
Unique Subject ID: C4591001 1156 11561357; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021; Date of Last Dose: 07JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 07JAN2021 (1) 17:03
2 Placebo 27JAN2021 (21) 16:03
3 BNT162b 17MAY2021 (131) 17:20
4 BNT162b 07JUN2021 (152) 10:59
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
Time
1 INFEC Appendicitis APPENDICITIS 10JUN2021 (155) 10JUN2021 (155)
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 2 TC Y Resolved (10JUN2021) Study Treatment 4 4 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 4
FDA-CBER-2022-5812-0500105
Compound: PF -07302048; Protocol: C4591001 Page 5of 65
Reason(s) for Narrative: Related Serious Adverse Event; Appendicitis
Unique Subject ID: C4591001 1156 11561357; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021; Date of Last Dose: 07JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 07JAN2021
Completed VACCINATION 25FEB2021
Completed REPEAT SCREENING 1 17MAY2021
Completed OPEN LABEL TREATMENT 06JUL2021
FOLLOW -UP
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 5
FDA-CBER-2022-5812-0500106
Compound: PF -07302048; Protocol: C4591001 Page 6of 65
Reason(s) for Narrative: Related Serious Adverse Event; Appendicitis
Unique Subject ID: C4591001 1156 11561357; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021; Date of Last Dose: 07JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Narrative Comment
Subject C4591001 1156 11561357, a 12-year-old White female with no pertinent medical history, received Dose 1 on 07 Jan2021, Dose 2 on 27 Jan2021 (Day 21), Dose 3
on 17 May 2021 (Day 131), and Dose 4 on 07 Jun2021 (Day 152).
The subject was diagnosed with appendicitis on 10 Jun2021, 3 days after receiving Dose 4.
On 10 Jun2021 (Day 155), the subject presented to the hospital with abdominal pain and vomiting. The pain was described as moderate, achy, and crampy, located in the
periumbilical and right flank areas, which worsened by movement and was relieved by rest. There were no risk factors reported. The subject’s labora tory results were within
normal limits. An abdominal ultrasound revealed findings consistent with acute appendicitis. The subjec t was treated with intravenous (IV) dextrose/normal
saline/potassium chloride 85 mL hourly, IV metronidazole 1350 mg once, IV morphine 0.25 mL every 2 hours, IV normal saline bolus 1000 mL once, and IV ceftriaxone
sodium 2000 mg once. On the same day (Day 155), the subject underwent an appendectomy as an outpatient procedure. The appendicitis (which was considered medically
significant) resolved, and the subject was discharged from the hospital on the same day with advice to take oral acetaminophe n 325 mgand ibuprofen 400 mg as needed. Per
the subject’s mother, the subject only took analgesics for 3 days and she completely recovered.
In the opinion of the investigator, there was a reasonable possibility that the appendicitis was related to the study inte rvention but unrelated to concomitant medications or
clinical trial procedures. Pfizer did not concur with the investigator’s causality assessment. Per Pfizer, there was no rea sonable possibility that the appendicitis was related to
the study interventio n.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 6
FDA-CBER-2022-5812-0500107
Compound: PF-07302048; Protocol: C4591001 Page 7of 65
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: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)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 BNT162b 05JAN2021 (1) 17:10
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 7
(b) (6)
FDA-CBER-2022-5812-0500108
Compound: PF -07302048; Protocol: C4591001 Page 8of 65
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: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)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
Investigator Text WHO Drug Preferred Term Start Date
BNT162b2 Dose #1 IM/once TOZINAMERAN 07MAY2021
BNT162b2 Dose #2 IM/once TOZINAMERAN 04JUN2021
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 8
FDA-CBER-2022-5812-0500109
Compound: PF -07302048; Protocol: C4591001 Page 9of 65
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: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)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 ⁰F) 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 possibilit y that the pyrexia was related to the study intervention.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 9
FDA-CBER-2022-5812-0500110
Compound: PF -07302048; Protocol: C4591001 Page 10of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1007 10071499; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 03DEC2020; Date of Last Dose: 22DEC2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)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)
170 cm 50.9 kg 17.6 kg/m2 03DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Drug allergy Amoxicillin Drug hypersensitivity 2009 Present
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 10
(b) (6)
FDA-CBER-2022-5812-0500111
Compound: PF -07302048; Protocol: C4591001 Page 11of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1007 10071499; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 03DEC2020; Date of Last Dose: 22DEC2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 03DEC2020 (1) 16:21
2 Placebo 22DEC2020 (20) 15:18
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 MUSC Arthralgia left wrist pain 01MAY2021 (150) 03MAY2021 (152) 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 TC/TCN N Resolved (03MAY2021) NOT RELATED/OTHER: Trauma 2 131 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 11
FDA-CBER-2022-5812-0500112
Compound: PF-07302048; Protocol: C4591001 Page 12of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1007 10071499; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 03DEC2020; Date of Last Dose: 22DEC2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Nonstudy Vaccines
Investigator Text WHO Drug Preferred Term Start Date
SARS -CoV -2 vaccination Pfizer TOZINAMERAN 13MAY2021
SARS -CoV -2 mRNA vaccine Pfizer TOZINAMERAN 04JUN2021
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 03DEC2020
Completed VACCINATION 20JAN2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
Narrative Comment
Subject C4591001 1007 10071499, a 14-year-old White male with no pertinent medical history, received Dose 1 on 03 Dec2020 and Dose 2 on 22 Dec2020 (Day 20).
The subject experienced arthralgia (left wrist pain) on 01 May 2021, 130 days after receiving D ose2.
The arthralgia resolved on 03 May 2021 (Day 152).
In the opinion of the investigator, there was no reasonable possibility that the arthralgia was related to the study interven tion but it was related to trauma.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 12
FDA-CBER-2022-5812-0500113
Compound: PF -07302048; Protocol: C4591001 Page 13of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1007 10071499; Country: USA
Vaccine Group (as Administered): Placebo
Date of First Dose: 03DEC2020; Date of Last Dose: 22DEC2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 13
FDA-CBER-2022-5812-0500114
Compound: PF -07302048; Protocol: C4591001 Page 14of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1009 10091221; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 19OCT2020; Date of Last Dose: 07NOV2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)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)
162.56 cm 47.73 kg 18 kg/m2 19OCT2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
premenarchal Premenarche 2006 Present
TONSILLITIS Tonsillitis 10AUG2017 Past
BILATERAL HIP PAIN Arthralgia 2018 Present
BILATERAL ANKLE PAIN Arthralgia 2018 Present
BILATERAL KNEE PAIN Arthralgia 2018 Present
facial acne Acne FEB2020 Present
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 14
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0500115
Compound: PF -07302048; Protocol: C4591001 Page 15of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1009 10091221; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 19OCT2020; Date of Last Dose: 07NOV2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b 19OCT2020 (1) 13:58
2 BNT162b 07NOV2020 (20) 11:10
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 MUSC Arthralgia worsening right ankle pain 19OCT2020 (1) 17:00 19OCT2020 (1) 1
Adverse Events
AE
NumberToxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative
Day From
Prior
VaccinationNarrative
Event
1 3 TCN N Resolved (19OCT2020) NOT RELATED/OTHER: dance injury 1 1 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 15
FDA-CBER-2022-5812-0500116
Compound: PF -07302048; Protocol: C4591001 Page 16of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1009 10091221; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 19OCT2020; Date of Last Dose: 07NOV2020
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 19OCT2020
Completed VACCINATION 10DEC2020
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
Narrative Comment
Subject C4591001 1009 10091221, a 14-year-old White female with a pertinent medical history of arthralgia (bilateral ankle, hip, and knee pain; since 2018), received
Dose 1 on 19 Oct2020 and Dose 2 on 07 Nov 2020 (Day 20).
The subject experienced arthra lgia (worsening right ankle pain) on 19 Oct2020, approximately 3 hours after receiving Dose 1.
The arthralgia resolved on the same day (Day 1).
In the opinion of the investigator, there was no reasonable possibility that the arthralgia was related to the study intervention but was related to a dance injury.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 16
FDA-CBER-2022-5812-0500117
Compound: PF -07302048; Protocol: C4591001 Page 17of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1009 10091294; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07DEC2020; Date of Last Dose: 28APR2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2005 15 White Hispanic/Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
170.18 cm 51.55 kg 17.8 kg/m2 07DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
acne, generalized Acne 2017 Present
dermatitis, atopic Dermatitis atopic 2018 Present
menorrhagia Heavy menstrual bleeding 2018 Present
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 17
(b) (6)
FDA-CBER-2022-5812-0500118
Compound: PF -07302048; Protocol: C4591001 Page 18of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1009 10091294; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07DEC2020; Date of Last Dose: 28APR2021
============================================================================ ==============================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot D ate: 27SEP2021) Date of Generation: 01DEC2021
(13:16)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 07DEC2020 (1) 11:38
2 Placebo 28DEC2020 (22) 09:36
3 BNT162b 06APR2021 (121) 09:22
4 BNT162b 28APR2021 (143) 09:35
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 MUSC Arthralgia bilateral shoulder pain 22DEC2020 (16) 24DEC2020 (18) 3
2 GENRL Pain body aches 06APR2021 (121) 18:00 07APR2021 (122) 2
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 (24DEC2020) NOT RELATED/OTHER: lifting heavy object 1 16 Y
2 1 N N Resolved (07APR2021) Study Treatment 3 1 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 18
FDA-CBER-2022-5812-0500119
Compound: PF -07302048; Protocol: C4591001 Page 19of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1009 10091294; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07DEC2020; Date of Last Dose: 28APR2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdr awal
Completed SCREENING 07DEC2020
Completed VACCINATION 25JAN2021
Completed REPEAT SCREENING 1 06APR2021
Completed OPEN LABEL TREATMENT 01JUN2021
FOLLOW -UP
Narrative Comment
Subject C4591001 1009 10091294, a 15-year-old White female with no pertinent medical history, received Dose 1 on 07 Dec2020, Dose 2 on 28 Dec2020 (Day 22), Dose 3
on 06 Apr2021 (Day 121), and Dose 4 on 28 Apr2021 (Day 143).
The subject experienced arthralgia (bilateral shoulder pain) on 22 Dec2020, 15 days after receiving Dose 1.
The arthralgia resolved on 24 Dec2020 (Day 18).
In the opinion of the investigator, there was no reasonable possibility that the arthralgia was related to the study interve ntion but was due to lifting a heavy object.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 19
FDA-CBER-2022-5812-0500120
Compound: PF -07302048; Protocol: C4591001 Page 20of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1009 10091294; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07DEC2020; Date of Last Dose: 28APR2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 20
FDA-CBER-2022-5812-0500121
Compound: PF -07302048; Protocol: C4591001 Page 21of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1009 10091382; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 04JAN2021; Date of Last Dose: 02JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2006 14 White Hispanic/Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
160.02 cm 71 kg 27.7 kg/m2 04JAN2021 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
CELIAC DISEASE Coeliac disease 2013 Present
ANXIETY Anxiety 2018 Present
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 21
(b) (6)
FDA-CBER-2022-5812-0500122
Compound: PF -07302048; Protocol: C4591001 Page 22of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1009 10091382; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 04JAN2021; Date of Last Dose: 02JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Outp ut File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 04JAN2021 (1) 16:30
2 Placebo 25JAN2021 (22) 16:17
3 BNT162b 14MAY2021 (131) 09:08
4 BNT162b 02JUN2021 (150) 09:54
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 MUSC Arthralgia RIGHT KNEE PAIN 10JAN2021 (7) 25JAN2021 (22) 16
2 GENRL Chills chills 03JUN2021 (151) 03JUN2021 (151) 1
3 NERV Dizziness dizziness 15MAY2021 (132) 16MAY2021 (133) 2
4 MUSC Myalgia generalized muscle pain 15MAY2021 (132) 20MAY2021 (137) 6
5 GASTR Nausea nausea 15MAY2021 (132) 17MAY2021 (134) 3
6 RESP Rhinorrhoea rhinorrhea 15MAY2021 (132) 17MAY2021 (134) 3
Adverse Events
AE
NumberToxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative
Day From
Prior
VaccinationNarrative
Event
1 2 N N Resolved (25JAN2021) NOT RELATED/OTHER: DANCING OVERUSE 1 7 Y
2 1 N N Resolved (03JUN2021) Study Treatment 4 2 N
3 1 N N Resolved (16MAY2021) Study Treatment 3 2 N
4 1 N N Resolved (20MAY2021) Study Treatment 3 2 N
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 22
FDA-CBER-2022-5812-0500123
Compound: PF -07302048; Protocol: C4591001 Page 23of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1009 10091382; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 04JAN2021; Date of Last Dose: 02JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Outpu t File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Adverse Events
AE
NumberToxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative
Day From
Prior
VaccinationNarrative
Event
5 1 N N Resolved (17MAY2021) Study Treatment 3 2 N
6 1 N N Resolved (17MAY2021) Study Treatment 3 2 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 04JAN2021
Completed VACCINATION 25FEB2021
Completed REPEAT SCREENING 1 14MAY2021
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 23
FDA-CBER-2022-5812-0500124
Compound: PF -07302048; Protocol: C4591001 Page 24of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1009 10091382; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 04JAN2021; Date of Last Dose: 02JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed OPEN LABEL TREATMENT 02JUL2021
FOLLOW -UP
Narrative Comment
Subject C4591001 1009 10091382, a 14-year-old White female with no pertinent medical history, received Dose 1 on 04 Jan2021, Dose 2 on 25 Jan2021 (Day 22), Dose 3
on 14 May 2021 (Day 131), and Dose 4 on 02 Jun2021 (Day 150).
The subject experienced arthralgia (right knee pain) on 10 Jan2021, 6 days after receiving Dose 1.
The arthralgia resolved on 25 Jan2021 (Day 22).
In the opinion of the investigator, there was no reasonable possibility that the arthralgia was related to the study interven tion but was due to overuse from dancing.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 24
FDA-CBER-2022-5812-0500125
Compound: PF-07302048; Protocol: C4591001 Page 25of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1016 10161327; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 20OCT2020; Date of Last Dose: 22JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)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)
170.18 cm 52.73 kg 18.2 kg/m2 20OCT2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
asthma Asthma 24APR2009 Present
seasonal allergies Seasonal allergy 24APR2009 Present
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 25
(b) (6)
FDA-CBER-2022-5812-0500126
Compound: PF -07302048; Protocol: C4591001 Page 26of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1016 10161327; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 20OCT2020; Date of Last Dose: 22JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh , ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 20OCT2020 (1) 09:46
2 Placebo 10NOV2020 (22) 10:47
3 BNT162b 01JUN2021 (225) 15:15
4 BNT162b 22JUN2021 (246) 09:22
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)Toxicity
Grade
1 NERV Epilepsy epilepsy 29JUN2021 (253) 13:30 ONGOING 2
2 NERV Syncope syncope 09APR2021 (172) 09APR2021 (172) 1 2
Adverse Events
AE
NumberAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative
Day From
Prior
VaccinationNarrative
Event
1 N Y Yes NOT RELATED/OTHER: epilepsy -idiopathic 4 8 Y
2 N N Resolved (09APR2021) NOT RELATED/OTHER: unknown -possible dehydration 2 151 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 26
FDA-CBER-2022-5812-0500127
Compound: PF -07302048; Protocol: C4591001 Page 27of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1016 10161327; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 20OCT2020; Date of Last Dose: 22JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 20OCT2020
Completed VACCINATION 08DEC2020
Completed REPEAT SCREENING 1 01JUN2021
Completed OPEN LABEL TREATMENT 20JUL2021
FOLLOW -UP
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 27
FDA-CBER-2022-5812-0500128
Compound: PF -07302048; Protocol: C4591001 Page 28of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1016 10161327; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 20OCT2020; Date of Last Dose: 22JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Narrative Comment
Subject C4591001 1016 10161327, a 12-year-old White male with no pertinent medical history but with a family history of epilepsy ), received Dose 1 on
20Oct2020, Dose 2 on 10 Nov 2020 (Day 22), Dose 3 on 01 Jun2021 (Day 225), and Dose 4 on 22 Jun2021 (Day 246).
The subject was diagnosed with epilepsy on 29 Jun2021, 7 days after receiving Dose 4.
On 09 Apr 2021 (Day 172), the subject experienced syncope, possibly caused by dehydration, which resolved on the same day. Th e subject had a s eizure, which lasted for
30seconds on 29 Jun2021 (Day 253), after getting out of a hot tub. Per the subject’s mother, the subject started seeing “black in vision” and became dizz y, and later his
arms and legs were extended, followed by a few whole -body jerks. The subject had no vomiting, incontinence, or postictal symptoms. It was reported that the subject had no
history of febrile seizure. The subject visited his physician’s office and upon arrival, he was oriented. The epilepsy was c onsidered as an important medical event.
On 13 Jul2021 (Day 267), an electroencephalogram showed rare, isolated moderate to high amplitude nonrhythmic spike and sharp waves in the front al region. The
discharges repeated at a frequency of 3- 4 Hz and lasted up to 0.5 seconds. An isolated generalized spike and wave were also noted during photic stimulation. Photic
stimulation was performed, which showed epileptiform discharges or a significant increase in occurrence of epileptiform disch arges limited to the period of ph otic
stimulation. The subject was advised to follow-up in a month.
The epilepsy was ongoing at the time of the last available report. The subject’s mother reported that the subject had no fur ther seizures, was not taking any medications or
treatment for epilepsy, and would follow -up with a neurologist in 6 months.
In the opinion of the investigator, there was no reasonable possibility that the epilepsy was related to the study interventi on, concomitant medications, or clinical trial
procedures. Pfizer concurred with the investigator’s causality assessment. Per Pfizer, the epilepsy was more likely associated with a genetic p redisposition considering the
family historyof epilepsy disorder.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 28
(b) (6)
FDA-CBER-2022-5812-0500129
Compound: PF -07302048; Protocol: C4591001 Page 29of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1039 10391285; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 18DEC2020; Date of Last Dose: 04JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)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)
156.1 cm 40.8 kg 16.7 kg/m2 18DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
premenarche Premenarche 2007 Present
amoxicillin allergy Drug hypersensitivity 2010 Present
vegetarian Vegetarian 2019 Present
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 29
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0500130
Compound: PF -07302048; Protocol: C4591001 Page 30of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1039 10391285; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 18DEC2020; Date of Last Dose: 04JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 18DEC2020 (1) 09:59
2 Placebo 08JAN2021 (22) 08:51
3 BNT162b 14MAY2021 (148) 08:35
4 BNT162b 04JUN2021 (169) 08:16
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
Time
1 MUSC Arthralgia Generalized Arthralgia 04JUN2021 (169) 14:00 05JUN2021 (170)
2 GENRL Fatigue fatigue 14MAY2021 (148) 18:00 15MAY2021 (149) 18:00
3 GENRL Injection site pain injection site pain 15MAY2021 (149) 08:00 15MAY2021 (149)
4 MUSC Myalgia muscle aches 04JUN2021 (169) 14:00 05JUN2021 (170)
5 GASTR Nausea nausea 14MAY2021 (148) 18:00 15MAY2021 (149) 18:00
6 GASTR Nausea nausea 04JUN2021 (169) 14:00 05JUN2021 (170)
7 GENRL Pyrexia fever 04JUN2021 (169) 14:00 05JUN2021 (170)
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 2 1 N N Resolved (05JUN2021) Study Treatment 4 1 Y
2 2 1 N N Resolved (15MAY2021) Study Treatment 3 1 N
3 1 1 N N Resolved (15MAY2021) Study Treatment 3 2 N
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 30
FDA-CBER-2022-5812-0500131
Compound: PF -07302048; Protocol: C4591001 Page 31of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1039 10391285; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 18DEC2020; Date of Last Dose: 04JUN2021
=============================================================================================== ===========================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Da te of Generation: 01DEC2021
(13:16)Adverse Events
AE
NumberDuration
(Days)Toxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative
Day From
Prior
VaccinationNarrative
Event
4 2 1 N N Resolved (05JUN2021) Study Treatment 4 1 N
5 2 1 N N Resolved (15MAY2021) Study Treatment 3 1 N
6 2 1 N N Resolved (05JUN2021) Study Treatment 4 1 N
7 2 1 N N Resolved (05JUN2021) Study Treatment 4 1 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 18DEC2020
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 31
FDA-CBER-2022-5812-0500132
Compound: PF -07302048; Protocol: C4591001 Page 32of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1039 10391285; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 18DEC2020; Date of Last Dose: 04JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:1 6)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed VACCINATION 05FEB2021
Completed REPEAT SCREENING 1 14MAY2021
Completed OPEN LABEL TREATMENT 12JUL2021
FOLLOW -UP
Narrative Comment
Subject C4591001 1039 10391285, a 13-year-old White female with no pertinent medical history, received Dose 1 on 18 Dec2020, Dose 2 on 08 Jan2021 (Day 22), Dose 3
on 14 May 2021 (Day 148), and Dose 4 on 04 Jun2021 (Day 169).
The subject experienced arthralgia (generalized arthralgia) on 04 Jun2021, approximately 6 hours after receiving Dose 4.
On the same day (Day 169), the subject also experienced nausea, pyrexia, and myalgia. The arthralgia, nausea, pyrexia, and myalgia resolved on 05 Jun2021 (Day 170).
In the opinion of the investigator, there was a reasonable possibility that the arthralgia was related to the study intervent ion.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 32
FDA-CBER-2022-5812-0500133
Compound: PF -07302048; Protocol: C4591001 Page 33of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1131 11311301; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 11JAN2021; Date of Last Dose: 05FEB2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2007 13 White Non-Hispanic/non -Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
161.2 cm 45.5 kg 17.5 kg/m2 11JAN2021 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
allergic rhinitis seasonal Seasonal allergy 2014 Present
adenoids removed Adenoidectomy 2015 Past
fall off diving board Fall 2015 Past
stiches insertion back of head Suture insertion 2015 Past
attention deficit hyperactivity disorder Attention deficit hyperactivity disorder 2017 Present
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 33
(b) (6)
FDA-CBER-2022-5812-0500134
Compound: PF -07302048; Protocol: C4591001 Page 34of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1131 11311301; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 11JAN2021; Date of Last Dose: 05FEB2021
======================================================================================= ===================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2 021) Date of Generation: 01DEC2021
(13:16)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b 11JAN2021 (1) 14:50
2 BNT162b 05FEB2021 (26) 14:06
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 INJ&P Accident skiing accident 18FEB2021 (39) 11:00 19FEB2021 (40) 2
2 MUSC Arthralgia sacroiliac joint pain 15JAN2021 (5) 08FEB2021 (29) 25
3 INJ&P Clavicle fracture right clavicle fracture 19FEB2021 (40) 11:00 23APR2021 (103) 64
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 Resolved (19FEB2021) NOT RELATED/OTHER: accident 2 14 N
2 2 N N Resolved (08FEB2021) NOT RELATED/OTHER: excess exercise 1 5 Y
3 2 TC/TCN N Resolved (23APR2021) NOT RELATED/OTHER: skiing accident 2 15 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 34
FDA-CBER-2022-5812-0500135
Compound: PF -07302048; Protocol: C4591001 Page 35of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1131 11311301; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 11JAN2021; Date of Last Dose: 05FEB2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 11JAN2021
Completed VACCINATION 12MAR2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
Narrative Comment
Subject C4591001 1131 11311301, a 13-year-old White male with no pertinent medical history, received Dose 1 on 11 Jan2021 and Dose 2 on 05 Feb2021 (Day 26).
The subject experienced arthralgia (sacroiliac joint pain) on 15 Jan2021, 4 days after receiving Dose 1.
The arthralgia resolved on 08 Feb2021 (Day 29).
In the opinion of the investigator, there was no reasonable possibility that the arthralgia was related to the study intervention but was due to excessive exercise.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 35
FDA-CBER-2022-5812-0500136
Compound: PF -07302048; Protocol: C4591001 Page 36of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1139 11391246; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 08JAN2021; Date of Last Dose: 10JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)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)
179.07 cm 71.82 kg 22.3 kg/m2 08JAN2021 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
dyslexia Dyslexia 2005 Present
sleep disturbance Sleep disorder 30JUN2015 Present
intermittent muscle strain Muscle strain 30JUN2018 Present
Acne Acne 30JUN2019 Present
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 36
(b) (6)
FDA-CBER-2022-5812-0500137
Compound: PF -07302048; Protocol: C4591001 Page 37of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1139 11391246; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 08JAN2021; Date of Last Dose: 10JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 08JAN2021 (1) 16:52
2 Placebo 29JAN2021 (22) 13:53
3 BNT162b 20MAY2021 (133) 16:48
4 BNT162b 10JUN2021 (154) 11:51
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)Toxicity
GradeAction
to
Subject
1 MUSC Arthralgia Bilateral knee pain 11JAN2021 (4) 12:00 15FEB2021 (39) 12:00 36 2 TC
Adverse Events
AE
Number SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative
Day From
Prior
VaccinationNarrative
Event
1 N Resolved (15FEB2021) NOT RELATED/OTHER: overuse injury from running, patellar tendonitis 1 4 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 37
FDA-CBER-2022-5812-0500138
Compound: PF -07302048; Protocol: C4591001 Page 38of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1139 11391246; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 08JAN2021; Date of Last Dose: 10JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 08JAN2021
Completed VACCINATION 26FEB2021
Completed REPEAT SCREENING 1 20MAY2021
Completed OPEN LABEL TREATMENT 16AUG2021
FOLLOW -UP
Narrative Comment
Subject C4591001 1139 11391246, a 15-year-old White male with a pertinent medical history of muscle strain (intermittent, since 30 Jun2018), received Dose 1 on
08Jan2021, Dose 2 on 29 Jan2021 (Day 22), Dose 3 on 20 May 2021 (Day 133), and Dose 4 on 10 Jun2021 (Day 154).
The subject experienced arthralgia (bilateral knee pain) on 11 Jan2021, 3 days after receiving Dose 1.
The arthralgia resolved on 15 Feb2021 (Day 39).
In the opinion of the investigator, there was no reasonable possibility that the arthralgia was related to the study intervention but was due to patellar tendonitis, an overuse
injury from running.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 38
FDA-CBER-2022-5812-0500139
Compound: PF -07302048; Protocol: C4591001 Page 39of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1150 11501210; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 15DEC2020; Date of Last Dose: 14JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2008 12 White Non-Hispanic/non -Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
149.86 cm 39.14 kg 17.4 kg/m2 15DEC2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Seasonal Allergies Seasonal allergy 2018 Present
Premenarchal Premenarche NOV2020 Present
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 39
(b) (6)
FDA-CBER-2022-5812-0500140
Compound: PF -07302048; Protocol: C4591001 Page 40of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1150 11501210; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 15DEC2020; Date of Last Dose: 14JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 15DEC2020 (1) 15:10
2 Placebo 07JAN2021 (24) 11:38
3 BNT162b 24MAY2021 (161) 15:13
4 BNT162b 14JUN2021 (182) 15:33
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
Time
1 MUSC Arthralgia Generalized joint Pain 14JUN2021 (182) 18:00 16JUN2021 (184)
2 GENRL Fatigue Fatigue 14JUN2021 (182) 18:00 16JUN2021 (184)
3 GENRL Injection site pain Pain at injection site 24MAY2021 (161) 18:00 26MAY2021 (163)
4 GENRL Injection site pain Pain at injection site 14JUN2021 (182) 18:00 16JUN2021 (184)
5 MUSC Myalgia Muscle Pain 14JUN2021 (182) 18:00 16JUN2021 (184)
6 GENRL Pyrexia Fever 15JUN2021 (183) 15JUN2021 (183)
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 (16JUN2021) Study Treatment 4 1 Y
2 3 2 N N Resolved (16JUN2021) Study Treatment 4 1 N
3 3 2 N N Resolved (26MAY2021) Study Treatment 3 1 N
4 3 2 N N Resolved (16JUN2021) Study Treatment 4 1 N
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 40
FDA-CBER-2022-5812-0500141
Compound: PF-07302048; Protocol: C4591001 Page 41of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1150 11501210; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 15DEC2020; Date of Last Dose: 14JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Adverse Events
AE
NumberDuration
(Days)Toxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative
Day From
Prior
VaccinationNarrative
Event
5 3 1 N N Resolved (16JUN2021) Study Treatment 4 1 N
6 1 1 N N Resolved (15JUN2021) Study Treatment 4 2 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Compl etion
Date Reason for Withdrawal
Completed SCREENING 15DEC2020
Completed VACCINATION 04FEB2021
Completed REPEAT SCREENING 1 24MAY2021
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 41
FDA-CBER-2022-5812-0500142
Compound: PF -07302048; Protocol: C4591001 Page 42of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1150 11501210; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 15DEC2020; Date of Last Dose: 14JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unbl inded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 0 1DEC2021
(13:16)Subject Summary
Status Study PhaseWithdrawal/Compl etion
Date Reason for Withdrawal
Completed OPEN LABEL TREATMENT 13JUL2021
FOLLOW -UP
Narrative Comment
Subject C4591001 1150 11501210, a 12-year-old White female with no pertinent medical history, received Dose 1 on 15 Dec2020, Dose 2 on 07 Jan2021 (Day 24), Dose 3
on 24 May 2021 (Day 161), and Dose 4 on 14 Jun2021 (Day 182).
The subject experienced arthralgia (generalized joint pain) on 14 Jun2021, approximately 2 hours and 30 minutes after receiving Dose 4.
The subject also experienced injection site pain, fatigue, and myalgia on 14 Jun2021 (Day 182), and pyrexia on 15 Jun2021 (Day 183). The pyrex ia resolved on
15Jun2021 (Day 183), and the arthralgia, fatigue, injection site pain, and myalgia resolved on 16 Jun2021 (Day 184).
In the opinion of the investigator, there was a reasonable possibility that the arthralgia was related to the study intervention.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 42
FDA-CBER-2022-5812-0500143
Compound: PF -07302048; Protocol: C4 591001 Page 43of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1150 11501294; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 11JAN2021; Date of Last Dose: 16JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2008 12 Black or African American Hispanic/Latino F
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
161.93 cm 58.91 kg 22.4 kg/m2 11JAN2021 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
Oral Allergy Syndrome Oral allergy syndrome 2010 Present
Asthma Asthma 2015 Present
Atopic Dermatitis Dermatitis atopic 2015 Present
Major Depressive Disorder Major depression 2020 Past
Vitamin D deficiency Vitamin D deficiency 2020 Present
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 43
(b) (6)
FDA-CBER-2022-5812-0500144
Compound: PF -07302048; Protocol: C4591001 Page 44of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1150 11501294; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 11JAN2021; Date of Last Dose: 16JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 11JAN2021 (1) 14:04
2 Placebo 01FEB2021 (22) 17:17
3 BNT162b 27MAY2021 (137) 14:00
4 BNT162b 16JUN2021 (157) 16:11
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
Time
1 EAR Conductive deafness Left sided mild conductive
hearing loss14JAN2021 (4) MAY2021 ()
2 GENRL Injection site pain Pain at injection site 27MAY2021 (137) 18:00 29MAY2021 (139)
3 GENRL Injection site pain Pain at injection site 16JUN2021 (157) 18:00 17JUN2021 (158)
4 GENRL Injection site swelling Swollen at injection site 27MAY2021 (137) 18:00 29MAY2021 (139)
Adverse Events
AE
NumberDuration
(Days)Toxicity
GradeAction
to
Subject SAE AE Still Present? AERelated To:Prior
Vaccination
NumberRelative
Day From
Prior
VaccinationNarrative
Event
1 2 N N Resolved (MAY2021) Study Treatment 1 4 Y
2 3 1 N N Resolved (29MAY2021) Study Treatment 3 1 N
3 2 1 N N Resolved (17JUN2021) Study Treatment 4 1 N
4 3 1 N N Resolved (29MAY2021) Study Treatment 3 1 N
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 44
FDA-CBER-2022-5812-0500145
Compound: PF -07302048; Protocol: C4591001 Page 45of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1150 11501294; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 11JAN2021; Date of Last Dose: 16JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL S DTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 11JAN2021
Completed VACCINATION 03MAR2021
Completed REPEAT SCREENING 1 27MAY2021
Completed OPEN LABEL TREATMENT 15JUL2021
FOLLOW -UP
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 45
FDA-CBER-2022-5812-0500146
Compound: PF -07302048; Protocol: C4591001 Page 46of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1150 11501294; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 11JAN2021; Date of Last Dose: 16JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)Narrative Comment
Subject C4591001 1150 11501294, a 12-year-old Black/African American female with a pertinent medical history of atopic dermatitis (since 2015) and vitamin D deficiency
(since 2020), received Dose 1 on 11 Jan2021, Dose 2 on 01 Feb2021 (Day 22), Dose 3 on 27May 2021 (Day 137), and Dose 4 on 16 Jun2021 (Day 157).
The subject was diagnosed with conductive deafness (left-sided mild conductive hearing loss) on 14 Jan2021, 3 days after receiving Dose 1.
The conductive deafness resolved on an unspecified dat e in May 2021.
In the opinion of the investigator, there was a reasonable possibility that the conductive deafness was related to the study intervention.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 46
FDA-CBER-2022-5812-0500147
Compound: PF -07302048; Protocol: C4591001 Page 47of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1223 12231273; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 09JAN2021; Date of Last Dose: 10JUN2021
=================================================== =======================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)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 66.4 kg 23.2 kg/m2 09JAN2021 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
seasonal allergies Seasonal allergy 2005 Present
Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 09JAN2021 (1) 10:25
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 47
(b) (6)
FDA-CBER-2022-5812-0500148
Compound: PF -07302048; Protocol: C4591001 Page 48of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1223 12231273; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 09JAN2021; Date of Last Dose: 10JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
2 Placebo 29JAN2021 (21) 15:36
3 BNT162b 21MAY2021 (133) 13:12
4 BNT162b 10JUN2021 (153) 09:58
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 CARD Myocarditis Myopericarditis 12JUN2021 (155) 19:00 13JUN2021 (156) 2
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 Y Resolved (13JUN2021) NOT RELATED/OTHER: Rhinovirus infection 4 3 Y
Prohibited Concomitant Medications
Investigator Text WHO Drug Preferred Term Start Date End Date Route
prednisone PREDNISONE 13JUN2021 ONGOING ORAL
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 48
FDA-CBER-2022-5812-0500149
Compound: PF -07302048; Protocol: C4591001 Page 49of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1223 12231273; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 09JAN2021; Date of Last Dose: 10JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 09JAN2021
Completed VACCINATION 03MAR2021
Completed REPEAT SCREENING 1 21MAY2021
Completed OPEN LABEL TREATMENT 09JUL2021
FOLLOW -UP
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 49
FDA-CBER-2022-5812-0500150
Compound: PF -07302048; Protocol: C4591001 Page 50of 65
Reason(s) for Narrative: AE of Clinical Interest
Unique Subject ID: C4591001 1223 12231273; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 09JAN2021; Date of Last Dose: 10JUN2021
=============================================================================================== ===========================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)Narrative Comment
Subject C4591001 1223 12231273, a 15-year-old White male with a pertinent medical history of seasonal allergy (since 2005), received Dose 1 on 09 Jan2021, Dose 2 on
29Jan2021 (Day 21), Dose 3 on 21 May 2021 (Day 133), and Dose 4 on 10 Jun2021 (Day 153).
The subject was diagnosed with myocarditis on 12 Jun2021, 2 days after receiving Dose 4.
The subject experienced chest tightness with pain at 7 PM on 12 Jun2021 (Day 155) after a dance rehearsal, and the subject’s mother used a salbutamol nebulizer o nce at
home, without any improvement. Later, he was taken to the emergency department because of the chest pain. Upon arrival at t he emergency department, his body
temperature was 100.1°F. It was reported that the subject initially had chest tightness, followed by chest pain. On the same day (Day 155), an electrocardiogram (ECG)
showed diffuse ST elevations, and his troponin level was 0.27 (units and normal range [NR] not available). The subject recei ved ketorolac 30 mg with almost immediate
relief of chest pain. It was reported that the subject had a body temperature of 100.5 ⁰F associated with a cough and rhinorrhea approximately one week prior to the chest
pain. On 13 Jun2021 (Day 156), the chest pain resolved. The subject was then transferred to a children's hospital for further evaluation. On the same day (Day 156), his
troponin T levels were 0.18 ng/mL and 0.71 ng/mL (NR: 0 to <0.01 ng/mL) at 05:51 hours and 11:57 hours, respectively. A rhinovirus polymerase chain reaction test was
positive on a respiratory virus panel, and enterovirus, parvovirus B 19, and SARS -CoV -2 RNA test results were negative. The subject received a single dose of paracetamol
650mg orally (PO) and diphenhydramine 25 mg PO on 13 Jun2021 (Day 156). Additionally, he also received prednisone 30 mg PO twice a day (BID), ibuprofen 600 mg
PO every 6 hours, intravenous immunoglobulins infusions, and famotidine 20 mg PO BID (all from 13 Jun2021). The myocarditis resolved on 13 Jun2021 (Day 156). The
subject was doing well w ithout chest pain, denied fever, chills, and shortness of breath, and was discharged from the hospital on 14 Jun2021 (Day 157). The subject was
advised to follow -up with a pediatric cardiologist. His discharge medications included ibuprofen 600 mg PO as needed (PRN) (until 23 Jun2021), famotidine 20 mg PO
(BID from 14 Jun2021 to 26 Jun2021 and once daily from 27 Jun2021 to 28 Jun2021), and tapering doses of prednisone PO (to 2.5 mg daily until 17 Jul2021). There was
no recurrence of cough or rhino rrhea. On 24 Jun2021 (Day 167), the subject had a follow -up with a cardiologist and an ECG was performed, which showed sinus rhythm
and ST elevation (probably normal early repolarization pattern), which had significantly improved since the ECG performed on 13 Jun2021. An echocardiogram showed
normal biventricular function, left ventricular global longitudinal strain of 19% (the strain was lower in the basal anterior , anteroseptal, inferoseptal, and inferior segments).
The coronaries were normal with no dilation. His troponin T level was <0.01 ng/mL. The cardiologist recommended that the subject limit his activity to not induce
tachycardia on exertion and to continue follow -up with cardiology.
In the opinion of the investigator, there was no reasonab le possibility that the myocarditis was related to the study intervention or clinical trial procedures, but it was related
to a rhinovirus infection. Pfizer did not concur with the investigator’s causality assessment. Per Pfizer, there was a reas onable p ossibility that the myocarditis was related to
the study intervention, based on the plausible temporal relationship and prior reports of myocarditis and pericarditis in rec ipients of mRNA vaccines in younger individuals,
but without confirmed causal association. However, this subject experienced chest tightness and pain after a dance rehearsal and was then treated with a salbut amol
nebulizer by his mother. It was not clear if the subject had a relevant medical history for which the nebulizer was availabl eat home. The reported symptoms and test results
could also be due to the rhinovirus infection.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 50
FDA-CBER-2022-5812-0500151
Compound: PF -07302048; Protocol: C4591001 Page 51of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1005 10051449; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 11JAN2021; Date of Last Dose: 01FEB2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Demography
Date of Birth Age at Enrollment (Years) Race Ethnicity Sex
2006 14 White Hispanic/Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
178.31 cm 82.82 kg 26 kg/m2 11JAN2021 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
ENVIRONMENTAL ALLERGIES Hypersensitivity 2010 Present
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 51
(b) (6)
FDA-CBER-2022-5812-0500152
Compound: PF -07302048; Protocol: C4591001 Page 52of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1005 10051449; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 11JAN2021; Date of Last Dose: 01FEB2021
============================================================================================== ============================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) D ate of Generation: 01DEC2021
(13:16)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b 11JAN2021 (1) 12:48
2 BNT162b 01FEB2021 (22) 11:21
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 INFEC Appendicitis Appendicitis 28JUN2021 (169) 29JUN2021 (170) 2
Adverse Events
AE
NumberToxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative
Day From
Prior
VaccinationNarrative
Event
1 2 TCN Y Resolved (29JUN2021) NOT RELATED/OTHER: unknown 2 148 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 52
FDA-CBER-2022-5812-0500153
Compound: PF -07302048; Protocol: C4591001 Page 53of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1005 10051449; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 11JAN2021; Date of Last Dose: 01FEB2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 11JAN2021
Completed VACCINATION 01MAR2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
Narrative Comment
Subject C4591001 1005 10051449, a 14-year-old White male with no pertinent medical history, received Dose 1 on 11 Jan2021 and Dose 2 on 01 Feb2021 (Day 22).
The subject was diagnosed with appendicitis on 28 Jun2021, 147 days after receiving Dose 2.
On 28 Jun2021 (Day 169), the subject presented to the emergency department with abdominal pain, mild fever, nausea, and vomiting (once). On the next day (Day 170), the
laboratory investigation showed an elevated white blood cell count of 15.8 × 109/L, absolute neutrophils of 13.2 × 109/L, absolute immature granulocyte of 0.1 × 109/L,
immature granulocyte of 0.6%, bilirubin of 2.1 mg/dL, direct bilirubin of 0.7 mg/dL; and low lymphocytes of 5.5% (normal ranges were not reported). A rapid SARS -CoV -2
test w as negative, and an abdominal ultrasound showed appendicitis. On the same day (Day 170), the subject underwent an appendectomy and the appendicitis (which was
considered as an important medical event) resolved, and the subject was discharged from the hosp ital.
In the opinion of the investigator, there was no reasonable possibility that the appendicitis was related to the study interv ention or clinical trial procedures. Pfizer concurred
with the investigator’s causality assessment.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 53
FDA-CBER-2022-5812-0500154
Compound: PF-07302048; Protocol: C4591001 Page 54of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1005 10051449; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 11JAN2021; Date of Last Dose: 01FEB2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 54
FDA-CBER-2022-5812-0500155
Compound: PF -07302048; Protocol: C4591001 Page 55of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1007 10071581; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 17DEC2020; Date of Last Dose: 14JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)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
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 55
(b) (6)
FDA-CBER-2022-5812-0500156
Compound: PF -07302048; Protocol: C4591001 Page 56of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1007 10071581; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 17DEC2020; Date of Last Dose: 14JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)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
3 BNT162b 24MAY2021 (159) 12:07
4 BNT162b 14JUN2021 (180) 11:23
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 INFEC Appendicitis Appendicitis 10MAR2021 (84) 29MAR2021 (103) 20
2 GENRL Fatigue fatigue 15JUN2021 (181) 16JUN2021 (182) 2
3 GENRL Injection site pain injection site pain 15JUN2021 (181) 16JUN2021 (182) 2
4 MUSC Myalgia generalized muscle aches 15JUN2021 (181) 16JUN2021 (182) 2
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 Y Resolved (29MAR2021) NOT RELATED/OTHER: Infection 2 63 Y
2 2 N N Resolved (16JUN2021) Study Treatment 4 2 N
3 1 N N Resolved (16JUN2021) Study Treatment 4 2 N
4 2 TC N Resolved (16JUN2021) Study Treatment 4 2 N
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 56
FDA-CBER-2022-5812-0500157
Compound: PF-07302048; Protocol: C4591001 Page 57of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1007 10071581; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 17DEC2020; Date of Last Dose: 14JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm , ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 17DEC2020
Completed VACCINATION 04FEB2021
Completed REPEAT SCREENING 1 24MAY2021
Completed OPEN LABEL TREATMENT 13JUL2021
FOLLOW -UP
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 57
FDA-CBER-2022-5812-0500158
Compound: PF -07302048; Protocol: C4591001 Page 58of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1007 10071581; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 17DEC2020; Date of Last Dose: 14JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Narrative Comment
Subject C4591001 1007 10071581, a 15-year-old White male with no pertinent medical history, received Dose 1 on 17 Dec2020, Dose 2 on 07 Jan2021 (Day 22), Dose 3
on 24 May 2021 (Day 159), and Dose 4 on 14 Jun2021 (Day 180).
Concomitant medications incl uded dexmethylphenidate hydrochloride (since 2019) for attention deficit hyperactivity disorder and naproxen (since 16 Feb2021) for
migraine.
The subject was diagnosed with appendicitis on 10 Mar 2021, 62 days after receiving Dose 2.
On 11 Mar 2021 (Day 85), the subject presented to the emergency room with a 1 -day history of worsening abdominal pain that localized to the right lower quadrant. The
subject was subsequently hospitalized for nonoperative pain management. An abdominal ultrasound scan was co nsistent 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 mcL (normal range [NR]: 4.5 -5.3mcL) 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 count of 6.94 mcL (NR: 4.5 -13.5 mcL), hemoglobin of 15.3 g/dL (NR: 13.0- 16.0 g/dL), hematocrit of 44.9% (NR: 37.0% -49.0%), and platelet count of
357mcL (NR: 135-466 mcL). 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 IV ceftriaxone 2000 mg, b oth on 11 Mar 2021 (Day 85). On 12 Mar 2021 (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) for moderate pain, and PO
acetaminophen 325 mg every 4 -6 hours PRN for pain. The appendicitis resolved on 29 Mar 2021 (Day 103) with oral antibiotic treatment and no surgical intervention was
required.
In the opinion of the investigator, there was no reasonable possibility that the appendicitis was related to the study intervention, concomitant medications, or clinical trial
procedures. Pfizer concurred with the investigator’s causality assessment.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 58
FDA-CBER-2022-5812-0500159
Compound: PF -07302048; Protocol: C4591001 Page 59of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1091 10911447; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 22DEC2020; Date of Last Dose: 14JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)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)
158.8 cm 48.1 kg 19.1 kg/m2 22DEC2020 (1)
Medical History
No Medical History
Study Vaccina tion(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b 22DEC2020 (1) 10:41
2 BNT162b 14JAN2021 (24) 11:25
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 59
(b) (6)
FDA-CBER-2022-5812-0500160
Compound: PF -07302048; Protocol: C4591001 Page 60of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1091 10911447; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 22DEC2020; Date of Last Dose: 14JAN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 INFEC Appendicitis Appendicitis 09JUL2021 (200) 03:00 10JUL2021 (201) 08:00 2
Adverse Events
AE
NumberToxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative
Day From
Prior
VaccinationNarrative
Event
1 2 TCN Y Resolved (10JUL2021) NOT RELATED/OTHER: Appendicitis 2 177 Y
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 60
FDA-CBER-2022-5812-0500161
Compound: PF -07302048; Protocol: C4591001 Page 61of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1091 10911447; Country: USA
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 22DEC2020; Date of Last Dose: 14JAN2021
======================================================================================================================== ==
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 22DEC2020
Completed VACCINATION 15FEB2021
REPEAT SCREENING 1
OPEN LABEL TREATMENT
FOLLOW -UP
Narrative Comment
Subject C4591001 1091 10911447, a 15-year-old White male with no reported medical history, received Dose 1 on 22 Dec2020 and Dose 2 on 14 Jan2021 (Day 24).
The subject was diagnosed with appendicitis on 09 Jul2021, 176 days after receiving Dose 2.
On 12 Jul2021 (Day 203), the subject contacted the site and reported that he was hospitalized on 10 Jul2021 (Day 201) because of appendicitis. It was reported that the
subject had right lower quadrant pain, fever, and vomiting, and underwent an abdominal ultrasound on 09 Jul2021 (Day 200), which showed a 10.2 mm appendix with
possible perforation and fluid/debris in the pericecal region. On 10 Jul2021 (Day 201), he had an elevated white blood cell count of 21.8 × 103/mm3 (normal range:
4.5-13.0 ×103/m m3) and a rapid SARS -CoV -2 test (molecular point of care test) result was negative. On the same day (Day 201), the subject underwent a laparoscopic
appendectomy without any complications. Gangrene and localized peritonitis were noted during the procedure . The appendicitis resolved on 10 Jul2021 (Day 201), and the
subject was discharged from the hospital on 12 Jul2021 (Day 203) with instructions to take paracetamol 325 mg and ibuprofen 200 mg alternately.
In the opinion of the investigator, there was no reasonable possibility that the appendicitis was related to the study intervention, concomitant medications, or clinical tria l
procedures. Pfizer concurred with the investigator’s causality assessment.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 61
FDA-CBER-2022-5812-0500162
Compound: PF -07302048; Protocol: C4591001 Page 62of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1147 11471281; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 12DEC2020; Date of Last Dose: 03JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)Demography
Date of Birth Age at Enrollment (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
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 62
(b) (6)
FDA-CBER-2022-5812-0500163
Compound: PF -07302048; Protocol: C4591001 Page 63of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1147 11471281; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 12DEC2020; Date of Last Dose: 03JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, c m, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Ge neration: 01DEC2021
(13:16)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
3 BNT162b 14MAY2021 (154) 14:36
4 BNT162b 03JUN2021 (174) 10:32
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 INFEC Appendicitis Acute appendicitis 22JAN2021 (42) 16:00 23JAN2021 (43) 00:01 2
2 INFEC Focal peritonitis localized peritonitis, without
perforation or gangrene22JAN2021 (42) 16:00 23JAN2021 (43) 00:01 2
Adverse Events
AE
NumberToxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative
Day From
Prior
VaccinationNarrative
Event
1 4 TC/TCN Y Resolved (23JAN2021) NOT RELATED/OTHER: Acute appendicitis 2 19 Y
2 4 TC/TCN Y Resolved (23JAN2021) NOT RELATED/OTHER: Acute appendicitis 2 19 N
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 63
FDA-CBER-2022-5812-0500164
Compound: PF -07302048; Protocol: C4591001 Page 64of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1147 11471281; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 12DEC2020; Date of Last Dose: 03JUN2021
============================================================= =============================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
Subject Summary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 12DEC2020
Completed VACCINATION 06FEB2021
Completed REPEAT SCREENING 1 14MAY2021
Completed OPEN LABEL TREATMENT 07JUL2021
FOLLOW -UP
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 64
FDA-CBER-2022-5812-0500165
Compound: PF -07302048; Protocol: C4591001 Page 65of 65
Reason(s) for Narrative: Appendicitis
Unique Subject ID: C4591001 1147 11471281; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 12DEC2020; Date of Last Dose: 03JUN2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591 001_sBLA_Peds_Narrative_Safety/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:16)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, Dose 2 on 04 Jan2021 (Day 24), Dose 3 on 14 May 2021 (Day 154), and Dose 4 on 03 Jun2021 (Day 174).
Concomitant medications included polyethylene glycol (since 2013) for constipation, ferrous sulfate (since 27 May 2020) for iron deficiency an emia, and mupirocin (since
22Dec2020) for psoriasis.
The subject was diagnosed with appendicitis on 22 Jan2021, 18 days after receiving Dose 2.
On 22 Jan2021 (Day 42), the subject presented to the emergency room (ER) after experiencing localized acut e abdominal pain in the right lower quadrant for less than 5
hours. It was reported that the abdominal pain was associated with anorexia. The subject was tachycardic on arrival to the ER, and the right lower quadrant was focally
tender. 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 with no findings suggestive of appendiceal pe rforation. 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 an 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 sub ject received unspecified
intravenous fluids and immediately had a laparoscopic appendectomy procedure, which 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 considered life -threatening and medically significant
events by the investigator.
In the opinion of the investigator, there was no reasonable possibility that the appendicitis was related to the st udy intervention, concomitant medications, or clinical trial
procedures. Pfizer concurred with the investigator’s causality assessment.
090177e198c0ab96\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 65
FDA-CBER-2022-5812-0500166
Compound: PF -07302048; Protocol: C4591001 Page 1of 11
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021; Date of Last Dose: 19MAY2021
======================================================================================================= ===================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, lb, mo, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_COVID/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:01)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
090177e198c0ab95\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 66
(b) (6)
FDA-CBER-2022-5812-0500167
Compound: PF -07302048; Protocol: C4591001 Page 2of 11
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021 ; Date of Last Dose: 19MAY2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce, ho, lb, mo, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_COVID/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Gen eration: 01DEC2021
(13:01)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 Placebo 07JAN2021 (1) 09:43
3 BNT162b 19MAY2021 (133) 09:55
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
TimeDuration
(Days)
1 GASTR Abdominal pain upper INTERMITTENT STOMACH
PAIN25MAY2021 (139) 13JUL2021 (188) 50
2 GENRL Chills CHILLS 19MAY2021 (133) 21MAY2021 (135) 3
3 METAB Decreased appetite LOSS OF APPETITE 25MAY2021 (139) 13JUL2021 (188) 50
4 GENRL Fatigue FATIGUE 25MAY2021 (139) 13JUL2021 (188) 50
5 NERV Headache INTERMITTENT HEADACHES 19MAY2021 (133) 13JUL2021 (188) 56
6 MUSC Musculoskeletal chest pain Ribpain on right side 10FEB2021 (35) 10MAR2021 (63) 29
7 GASTR Nausea INTERMITTENT NAUSEA 19MAY2021 (133) 13JUL2021 (188) 56
8 GENRL Non-cardiac chest pain INTERMITTENT
NON-CARDIAC CHEST
DISCOMFORT19MAY2021 (133) 13JUL2021 (188) 56
9 INFEC Otitis media LEFT OTITIS MEDIA 29JUN2021 (174) 06JUL2021 (181) 8
10 GENRL Pyrexia Fever 20MAY2021 (134) 21MAY2021 (135) 2
11 SKIN Rash Rash on Right Foot 05APR2021 (89) 08APR2021 (92) 4
12 GENRL Thirst INCREASED THIRST 25MAY2021 (139) 12JUN2021 (157) 19
090177e198c0ab95\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 67
FDA-CBER-2022-5812-0500168
Compound: PF -07302048; Protocol: C4591001 Page 3of 11
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021; Date of Last Dose: 19MAY2021
=============================================================================================== ===========================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, lb, mo, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_COVID /profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:01)Adverse Events
AE
NumberToxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative
Day From
Prior
VaccinationNarrative
Event
1 2 N N Resolved (13JUL2021) Study Treatment 3 7 N
2 1 TC N Resolved ( 21MAY2021) Study Treatment 3 1 N
3 2 N N Resolved (13JUL2021) Study Treatment 3 7 N
4 3 N N Resolved (13JUL2021) Study Treatment 3 7 N
5 2 TC N Resolved (13JUL2021) Study Treatment 3 1 N
6 1 N N Resolved (10MAR2021) NOT RELATED/OTHER: Unknown 1 35 N
7 2 N N Resolved (13JUL2021) Study Treatment 3 1 N
8 2 TC N Resolved (13JUL2021) Study Treatment 3 1 N
9 1 TC N Resolved (06JUL2021) NOT RELATED/OTHER: UNKNOWN 3 42 N
10 1 TC N Resolved (21MAY2021) Study Treatment 3 2 N
11 1 TC N Resolved (08APR2021) NOT RELATED/OTHER: UNKNOWN 1 89 N
12 1 N N Resolved (12JUN2021) Study Treatment 3 7 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
Investigator Text WHO Drug Preferred Term Start Date
Fluarix Quadrivalent (Influenza Vaccine) INFLUENZA VACCINE INACT SPLIT 4V 21DEC2020
090177e198c0ab95\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 68
FDA-CBER-2022-5812-0500169
Compound: PF -07302048; Protocol: C4591001 Page 4of 11
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021; Date of Last Dose: 19MAY2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, lb, mo, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_COVID/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Gen eration: 01DEC2021
(13:01)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
090177e198c0ab95\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 69
FDA-CBER-2022-5812-0500170
Compound: PF -07302048; Protocol: C4591001 Page 5of 11
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021; Date of Last Dose: 19MAY2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, lb, mo, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_COVID/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Gen eration: 01DEC2021
(13:01)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)/
19JAN2021 (13)/
20JAN2021 (14)YES NEW OR INCREASED
SHORTNESS OF BREATH
COVID Illness Visit 2
/ 29JAN2021 (23)/
26JAN2021 (20)/
26JAN2021 (20)YES DIARRHEA
COVID Illness Visit 3
/ 01JUL2021 (176)/
24JUN2021 (169)/
06JUL2021 (181)NO Ear pain
YES NEW LOSS OF TASTE OR
SMELL
YES NEW OR INCREASED SORE
THROAT
NO Nasal congestion
090177e198c0ab95\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 70
FDA-CBER-2022-5812-0500171
Compound: PF -07302048; Protocol: C4591001 Page 6of 11
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021; Date of Last Dose: 19MAY2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, lb, mo, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_COVID/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:01)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
COVID Illness Visit 3 01JUL2021 (176) Sinus Infection 30JUN2021
(175)1 Sinusitis
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
3 COVID Illness Visit 3 01JUL2021 (176) 01JUL2021 (176) NASAL_SWAB_SELF NEGATIVE
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
2 COVID Illness Visit 3 01JUL2021 (176) 30JUN2021 (175) SWABBED MATERIAL NASOPHARYNX
090177e198c0ab95\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 71
FDA-CBER-2022-5812-0500172
Compound: PF -07302048; Protocol: C4591001 Page 7of 11
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021; Date of Last Dose: 19MAY2021
==========================================================================================================================
PFIZER C ONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce, ho, lb , mo, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_COVID/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2 021) Date of Generation: 01DEC2021
(13:01)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
2 NEGATIVE OTHER SARS -COV-2 TEST CLIA
CERIFIED LAB
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
090177e198c0ab95\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 72
FDA-CBER-2022-5812-0500173
Compound: PF -07302048; Protocol: C4591001 Page 8of 11
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021; Date of Last Dose: 19MAY2021
=============================================================================================== ===========================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, lb, mo, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_COVID/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:01)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 3 01JUL2021 (176) EMERGENCY ROOM NO NA
OTHER NO NA
SPECIALIST NO NA
URGENT CARE NO NA
PRIMARY CARE PHYSICIAN YES 1 NA
TELEPHONE CONSULTATION YES 1 NA
Hospitalization Details
No Hospitalization Details
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
090177e198c0ab95\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 73
FDA-CBER-2022-5812-0500174
Compound: PF -07302048; Protocol: C4591001 Page 9of 11
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021; Date of Last Dose: 19MAY2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, lb, mo, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_COVID/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Gen eration: 01DEC2021
(13:01)Laboratory Results -Hematology
No Laboratory Results -Hemat ology
Vital Signs -COVID -19
No Vital Signs -COVID -19
Oxygenation Parameters
No Oxygenation Parameters
Concomitant Medications -Vasopressors
No Concomitant Medications -Vasopressors
Imaging
No Imaging
090177e198c0ab95\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 74
FDA-CBER-2022-5812-0500175
Compound: PF -07302048; Protocol: C4591001 Page 10of 11
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021; Date of Last Dose: 19MAY2021
==========================================================================================================================
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce , ho, lb, mo, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_COVID/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2021) Date of Generation: 01DEC2021
(13:01)Subject S ummary
Status Study PhaseWithdrawal/Completion
Date Reason for Withdrawal
Completed SCREENING 07JAN2021
Withdrawn VACCINATION 26JAN2021 NO LONGER MEETS
ELIGIBILITY CRITERIA
Completed REPEAT SCREENING 1 19MAY2021
OPEN LABEL TREATMENT
Withdrawn FOLLOW -UP 13JUL2021 WITHDRAWAL BY
SUBJECT
090177e198c0ab95\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 75
FDA-CBER-2022-5812-0500176
Compound: PF -07302048; Protocol: C4591001 Page 11of 11
Reason(s) for Narrative: COVID -19 Case (Severe and/or Multiple)
Unique Subject ID: C4591001 1270 12701237; Country: USA
Vaccine Group (as Administered): Placebo => BNT162b2 (30 μg)
Date of First Dose: 07JAN2021; Date of Last Dose: 19MAY2021
==========================================================================================================================
PFIZER C ONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Data: dm, vs, mh, ex, ae, cm, mb, co, di, is, adc19ef, face, ce, ho, lb , mo, ds Output File:
./nda2_unblinded/C4591001_sBLA_Peds_Narrative_COVID/profile. (Cutoff Date: 02SEP2021, Snapshot Date: 27SEP2 021) Date of Generation: 01DEC2021
(13:01)Narrative Comment
Subject C4591001 1270 12701237, a 13-year-old American Indian or Alaska native female with a BMI of 27.2 kg/m2, received Dose 1 on 07 Jan2021.
The subject had a pertinent medical history of depression (since 02 Dec2014), asthma (since 01 Feb2016), anxiety (since 23 Aug 2019), vitamin D deficiency (since
22Jun2020), and drug hypersensitivity (allergy to vancomycin) and pectus carinatum (both s ince 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.
On 24 Jan2021 (Day 18), the subject was diagnosed with COVID -19 and repo rted new or increased shortness of breath, with the symptom starting on 19 Jan2021, 12 days
after receiving Dose 1, and the symptom resolved on 20 Jan2021 (Day 14).
The central laboratory SARS -CoV -2 NAAT result at the time of the COVID-19 illness on 21 Jan2021 (Day 15) was positive. The local laboratory SARS-CoV -2 NAAT
result at the time of the COVID -19 illness on 24 Jan2021 (Day 18) was positive. The subject did not have any contact with nonstudy healthcare personnel (at COVID illness
Visit 1).
On 26 Jan2021 (Day 20), the subject reported diarrhea, which resolved that same day.
The central laboratory SARS -CoV -2 NAAT result at the time of the COVID -19 illness on 29 Jan2021 (Day 23) was positive. The subject had a telephone consultation
(once, at COVID illness Visit 2).
The subject was discontinued from the study intervention on 26 Jan2021 since she no longer met th e eligibility criteria and remained in the study to be evaluated for safety,
immunogenicity, and efficacy.
The subject was rescreened and received an additional dose of study intervention on 19 May 2021 (Day 133).
On 30 Jun2021 (Day 175), the subject wa s diagnosed with sinusitis and reported ear pain, new loss of taste or smell, new or increased sore throat, and nasal congest ion, with
the first symptom starting on 24 Jun2021, 36 days after receiving the additional dose of study intervention, and the las t symptom resolved on 06 Jul2021 (Day 181).
The local laboratory SARS -CoV -2 NAAT result at the time of the potential COVID -19 illness visit on 30 Jun2021 (Day 175) was negative. The central laboratory
SARS -CoV -2 NAAT result at the time of the potentia l COVID -19 illness visit on 01 Jul2021 (Day 176) was negative.
The subject had a telephone consultation (once) and went to her primary care physician (once, at COVID illness Visit 3).
The subject was withdrawn from the study on 13 Jul2021 because she requested study withdrawal.
090177e198c0ab95\Final\Final On: 02-Dec-2021 01:43 (GMT)
Page 76
FDA-CBER-2022-5812-0500177