125742 S13 M5 5351 c4591001 adae hiv listing

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Listing of Severe, Serious, Life threatening, or Leading to Withdrawal Adverse Events From Dose 1 to Unblinding Date – 
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Populatio n 
Treatment Group/  
Age Group  
(Years)/  
Subject System 
Organ 
Class Preferred Term/  
AE Investigator  
Text Dose 
No. Onset 
Date Rel 
Daya/ 
Dur 
(Days)b Toxicity 
Grade Vax 
Relc Cause 
of 
AE Action: 
Investigational  
Vaccine Dose/  
Subject Outcome  
(End Date)  SAE/Imm  
AE 
(Yes/No) 
  
BNT162b2 (30 μg)/  
16-55/ 
C4591001 1226 
12262255  MUSC Myalgia/ 
muscle pain  1 19OCT2020  4/4 2 Yes   NA/TC R  
(22OCT2020)  N/N 
  GASTR Nausea/ 
Nauseas 2 06NOV2020  1/3 3 Yes   NA R  
(08NOV2020)  N/N 
    Vomiting/  
Vomiting  2 06NOV2020  1/3 3 Yes   NA/TC R  
(08NOV2020)  N/N 
  GENRL Chills/ 
Chills 2 06NOV2020  1/3 3 Yes   NA R  
(08NOV2020)  N/N 
    Injection site pain/  
Pain at the injection site  2 06NOV2020  1/3 3 Yes   NA R  
(08NOV2020)  N/N 
    Pyrexia/ 
Fever 39 C  2 06NOV2020  1/3 3 Yes   NA/TC R  
(08NOV2020)  N/N 
  MUSC Myalgia/ 
Muscle pain  2 06NOV2020  1/3 3 Yes   NA/TC R  
(08NOV2020)  N/N 
BNT162b2 (30 μg)/  
16-55/ 
C4591001 1230 
12301045  INJ&P Exposure during 
pregnancy/  
Exposure during 
Pregnancy  1 20OCT2020  22/C  
No O P UNK N/N 
Placebo/ 
16-55/ 
C4591001 1229 
12291083  METAB Diabetes mellitus/  
Diabetes Mellitus  2 28DEC2020  68/C 4 No O NA N Y/N 
  INFEC COVID-19 pneumonia/  
Covid 19 Pneumonia  2 01JAN2021  72/5 4 No O NA/W F  
(05JAN2021)  Y/N 
BNT162b2 (30 μg)/  
>55/ 
C4591001 1015 
10151238  INFEC Pneumonia/  
Pneumonia  2 20JAN2021  86/8 3 No O NA/TC R  
(27JAN2021)  Y/N 
090177e19792abdc\Final\Final On: 16-Jul-2021 05:07 (GMT)
FDA-CBER-2021-5683-0651241
Listing of Severe, Serious, Life threatening, or Leading to Withdrawal Adverse Events From Dose 1 to Unblinding Date – 
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Populatio n 
Treatment Group/  
Age Group  
(Years)/  
Subject System 
Organ 
Class Preferred Term/  
AE Investigator  
Text Dose 
No. Onset 
Date Rel 
Daya/ 
Dur 
(Days)b Toxicity 
Grade Vax 
Relc Cause 
of 
AE Action: 
Investigational  
Vaccine Dose/  
Subject Outcome  
(End Date)  SAE/Imm  
AE 
(Yes/No) 
  
  GENRL Oedema peripheral/  
Peripheral edema  2 03FEB2021  100/31 2 No O NA R  
(05MAR2021)  N/N 
BNT162b2 (30 μg)/  
>55/ 
C4591001 1156 
11561160  INJ&P Road traffic accident/  
MOTOR VEHICLE 
ACCIDENT  2 24DEC2020  74/1 4 No O NA/W F  
(24DEC2020)  Y/N 
  
Abbreviations: C = continuing; Dur = duration; Imm = immediate. Refer to the AE legend page (Listing 16.2.7.1) for additional  definitions.  
Note: MedDRA (v23.1) coding dictionary applied.  
a.     Relative day (Rel Day) = date of AE - date of last vaccination  + 1. For an AE that occurred before the date of the first study vaccination, + 1 was not 
added to compute relative day.  
b.     Duration (days) was calculated as the difference from the start of the first reported event to resolution of the last reporte d event, inclusive.  
c.     Vaccine related (Vax Rel): relationship to investigational vaccine as assessed by the investigator.  
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (20:15) Source Data: adae Table Generation: 12JUL2021 (14:58)  
(Cutoff Date: 13MAR2021,  Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_BLA_RR/adae_l002_fda_hiv   
 
090177e19792abdc\Final\Final On: 16-Jul-2021 05:07 (GMT)
FDA-CBER-2021-5683-0651242