Document text
Compound: PF -07302048; Protocol: C4591001 Page 1of 4
Reason(s) for Narrative: HIV
Unique Subject ID: C4591001 1226 12262255; Country: Brazil
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 16OCT2020; Date of Last Dose: 06NOV2020
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PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_HIV/profile Date of Generation: 12JUL2021 (13:23)Demography
Date of Birth Age at Enrollment (Years) Race Ethn icity Sex
1972 48 White Hispanic/Latino M
Vital Signs -Baseline
Height Weight BMIDate Collected
(Study Day)
173.8 cm 95.6 kg 31.6 kg/m2 16OCT2020 (1)
Medical History
Investigator Text MedDRA Preferred Term Start Date Disease Status
HIV HIV test positive 2010 Present
Obesity Obesity 2010 Present
contact dermatitis Dermatitis contact 2017 Present
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(b) (6)
FDA-CBER-2021-5683-0651243
Compound: PF -07302048; Protocol: C4591001 Page 2of 4
Reaso n(s) for Narrative: HIV
Unique Subject ID: C4591001 1226 12262255; Country: Brazil
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 16OCT2020; Date of Last Dose: 06NOV2020
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PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C459 1001_HIV/profile Date of Generation: 12JUL2021 (13:23)Study Vaccination(s)
Vaccination Number Vaccine Vaccination Date (Study Day) Time of Vaccination
1 BNT162b2 16OCT2020 (1) 14:00
2 BNT162b2 06NOV2020 (22) 12:22
Adverse Events
AE
NumberMedDRA
SOCMedDRA Preferred
Term Investigator TextStart Date
(Study Day)Start
TimeStop Date
(Study Day)Stop
Time
1 GENRL Chills Chills 06NOV2020 (22) 23:00 08NOV2020 (24)
2 GENRL Injection site pain Pain at the injection site 06NOV2020 (22) 23:00 08NOV2020 (24)
3 MUSC Myalgia Muscle pain 06NOV2020 (22) 23:00 08NOV2020 (24)
4 MUSC Myalgia muscle pain 19OCT2020 (4) 22OCT2020 (7)
5 GASTR Nausea Nauseas 06NOV2020 (22) 23:00 08NOV2020 (24)
6 GENRL Pyrexia Fever 39 C 06NOV2020 (22) 23:00 08NOV2020 (24)
7 GASTR Vomiting Vomiting 06NOV2020 (22) 23:00 08NOV2020 (24)
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 3 N N Resolved (08NOV2020) Study Treatment 2 1 N
2 3 3 N N Resol ved (08NOV2020) Study Treatment 2 1 N
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FDA-CBER-2021-5683-0651244
Compound: PF -07302048; Protocol: C4591001 Page 3of 4
Reason(s) for Narrative: HIV
Unique Subject ID: C4591001 1226 12262255; Country: Brazil
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 16OCT2020; Date of Last Dose: 06NOV2020
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=============
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: d m, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C4591001_HIV/profile Date of Generation: 12JUL2021 (13:23)Adverse Events
AE
NumberDuration
(Days)Toxicity
GradeAction
to
Subject SAE AE Still Present? AE Related To:Prior
Vaccination
NumberRelative
Day From
Prior
VaccinationNarrative
Event
3 3 3 TC N Resolved (08NOV2020) Study Treatment 2 1 N
4 4 2 TC N Resolved (22OCT2020) Study Treatment 1 4 N
5 3 3 N N Resolved (08NOV2020) Study Treatment 2 1 N
6 3 3 TC N Resolved (08NOV2020) Study Treatment 2 1 N
7 3 3 TC N Resolved (08NOV2020) Study Treatment 2 1 N
Prohibited Concomitant Medications
No Prohibited Concomitant Medications
Nonstudy Vaccines
No Nonstudy Vaccines
090177e1978a4cfc\Final\Final On: 13-Jul-2021 01:22 (GMT)
FDA-CBER-2021-5683-0651245
Compound: PF -07302048; Protocol: C4591001 Page 4of 4
Reason(s) for Narrative: HIV
Unique Subject ID: C4591001 1226 12262255; Country: Brazil
Vaccine Group (as Administered): BNT162b2 (30 μg)
Date of First Dose: 16OCT2020; Date of Last Dose: 06NOV2020
=============================================================================================================
=============
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output File:
./nda2_unblinded/C459 1001_HIV/profile Date of Generation: 12JUL2021 (13:23)Subject Summary
Status Study PhaseWithdrawal/Completion
DateReason for
Withdrawal
Completed SCREENING 16OCT2020
Completed VACCINATION 06JAN2021
REPEAT SCREENING 1
OPEN LABEL
TREATMENT
FOLLOW -UP
090177e1978a4cfc\Final\Final On: 13-Jul-2021 01:22 (GMT)
FDA-CBER-2021-5683-0651246