125742 S1 M5 CRF c4591001 1226 12261583

Document text

Page 1 of 202
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version30 JUN 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851229
Page 2 of 202
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/7/2020
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851230
Page 3 of 202
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12261583]
2.Birth Date: 1985
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851231
Page 4 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/7/2020
2.Erroneous Visit
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851232
Page 5 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion
criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55
years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years,
inclusive, at randomization (dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all
scheduled visits, vaccination plan, laboratory tests, lifestyle
considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN02A00
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851233
Page 6 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history,
physical examination, and clinical judgment of the investigator
to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which
includes compliance with the requirements and restrictions
listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past
year) or active suicidal ideation/behavior/lab abnormality that
may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX01A00
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851234
Page 7 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine
and/or severe allergic reaction (eg, anaphylaxis) to any
component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX04A00
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851235
Page 8 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or
laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged
bleeding that would, in the opinion of the investigator,
contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX11A00
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851236
Page 9 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as
cytotoxic agents or systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60
days before study intervention administration or planned
receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX14A01
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851237
Page 10 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention
within 28 days prior to study entry and/or during study
participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study
intervention containing lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in
the conduct of the study, site staff otherwise supervised by the
investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX21A01
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851238
Page 11 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851239
Page 12 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Systemic arterial hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Overweight]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851240
Page 13 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/7/2020
2.Weight: [97.1]
3.Unit: kg
4.Height: [175.8]
5.Unit: cm
6.Body Mass Index: [31.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851241
Page 14 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/7/2020
2.Randomization Number: [83035]
3.Randomization Group: [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851242
Page 15 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/7/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPHNXF]
5.bSample ID [BPHNXG]
5.cSample ID [BPTJRT]
5.dSample ID [BPTJRV]
5.eSample ID [BPTJRW]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851243
Page 16 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/7/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTJTC]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851244
Page 17 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/7/2020 10:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851245
Page 18 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851246
Page 19 of 202
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851247
Page 20 of 202
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851248
Page 21 of 202
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP7XHB]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851249
Page 22 of 202
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/29/2020 10:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851250
Page 23 of 202
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851251
Page 24 of 202
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS85FZ]
5.bSample ID [BS85G0]
5.cSample ID [BR7864]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851252
Page 25 of 202
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/23/2021
2.Erroneous Visit
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851253
Page 26 of 202
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/23/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGDR8]
5.bSample ID [BSCX6V]
5.cSample ID [BSCX6W]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851254
Page 27 of 202
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851255
Page 28 of 202
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851256
Page 29 of 202
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851257
Page 30 of 202
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851258
Page 31 of 202
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851259
Page 32 of 202
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851260
Page 33 of 202
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851261
Page 34 of 202
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851262
Page 35 of 202
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851263
Page 36 of 202
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851264
Page 37 of 202
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851265
Page 38 of 202
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851266
Page 39 of 202
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851267
Page 40 of 202
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851268
Page 41 of 202
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/27/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851269
Page 42 of 202
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851270
Page 43 of 202
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851271
Page 44 of 202
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851272
Page 45 of 202
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851273
Page 46 of 202
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851274
Page 47 of 202
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851275
Page 48 of 202
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851276
Page 49 of 202
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851277
Page 50 of 202
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851278
Page 51 of 202
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851279
Page 52 of 202
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851280
Page 53 of 202
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851281
Page 54 of 202
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851282
Page 55 of 202
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851283
Page 56 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Pain at the inj
ection site Sep/7/2020 1
6:00 NO
End Date Time:
Sep/8/2020 UNK:
UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  Pain at the inj
ection site Sep/30/2020
UNK:UNK NO
End Date Time:
Sep/30/2020 UNK
:UNK
 Repeating
Pages
 3.ADVERSE
EVENT 3  Left ureteral s
tone Nov/13/2020
22:00 NO
End Date Time:
Nov/15/2020 UN
K:UNK
 Repeating
Pages
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851284
Page 57 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Pain at the injection site]
4.Start Date Time: Sep/7/2020 16:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/8/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851285
Page 58 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851286
Page 59 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851287
Page 60 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Pain at the injection site]
4.Start Date Time: Sep/30/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/30/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851288
Page 61 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851289
Page 62 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851290
Page 63 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Left ureteral stone]
4.Start Date Time: Nov/13/2020 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/15/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851291
Page 64 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851292
Page 65 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020457143]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851293
Page 66 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851294
Page 67 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851295
Page 68 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851296
Page 69 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851297
Page 70 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851298
Page 71 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851299
Page 72 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851300
Page 73 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851301
Page 74 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851302
Page 75 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851303
Page 76 of 202
***Confidential***
 
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851304
Page 77 of 202
***Confidential***
 
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851305
Page 78 of 202
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/21/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851306
Page 79 of 202
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851307
Page 80 of 202
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851308
Page 81 of 202
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/27/2020
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851309
Page 82 of 202
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851310
Page 83 of 202
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Cristiano
Zerbini Approved Mar-24-2021 11:19:13 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851311
Page 84 of 202
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Cristiano
Zerbini Approved Mar-24-2021 11:19:13 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Mar-23-2021 11:25:38 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Feb-11-2021 17:31:45 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851312
Page 85 of 202
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-23-2021 10:20:51 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Nov-30-2020 15:32:16 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851313
Page 86 of 202
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Nov-18-2020 16:56:35 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Nov-02-2020 20:03:37 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851314
Page 87 of 202
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851315
Page 88 of 202
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-07-2020
15:54:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-07-2020
15:54:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851316
Page 89 of 202
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-07-2020
15:54:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Sep/7/2020Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851317
Page 90 of 202
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-07-2020
15:54:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12261583Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-07-2020
15:54:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1985Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-07-2020
15:54:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-07-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851318
Page 91 of 202
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
15:54:28
(UTC-03:00) City
of Buenos AiresHISPANIC OR LATI
NO(A) OR OF SPANI
SH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-07-2020
15:54:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851319
Page 92 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-07-2020
15:54:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851320
Page 93 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:1
Crit
erio
n D
escr
iptio
n:Male or female
participants bet
ween the ages o
f 18 and 55 yea
rs, inclusive, 65
and 85 years, in
clusive, or 18 a
nd 85 years, inc
lusive, at rando
mization (depen
dent upon study
stage)
Crit
erio
n m
et?:YESInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851321
Page 94 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female partici
pants between the age
s of 18 and 55 years, i
nclusive, 65 and 85 ye
ars, inclusive, or 18 an
d 85 years, inclusive,
at randomization (dep
endent upon study sta
ge)Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851322
Page 95 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.a Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n Nu
mbe
r:2Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851323
Page 96 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n De
scri
ptio
n:Participants wh
o are willing an
d able to compl
y with all sched
uled visits, vac
cination plan, l
aboratory tests,
lifestyle consid
erations, and ot
her study proce
dures
Crit
erio
n me
t?:YES
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN02A00
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851324
Page 97 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Inclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are
willing and able to co
mply with all schedul
ed visits, vaccination
plan, laboratory tests,
lifestyle consideration
s, and other study pro
ceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851325
Page 98 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:Healthy partici
pants who are d
etermined by m
edical history, p
hysical examin
ation, and clini
cal judgment of
the investigator
to be eligible fo
r inclusion in th
e study
Crit
erio
n m
et?:YESInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851326
Page 99 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN03A00
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851327
Page 100 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.c Inclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants w
ho are determined by
medical history, physi
cal examination, and c
linical judgment of th
e investigator to be eli
gible for inclusion in t
he studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851328
Page 101 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n Nu
mbe
r:4
Crit
erio
n De
scri
ptio
n:Capable of givi
ng personal sig
ned informed c
onsent, which i
ncludes compli
ance with the r
equirements an
d restrictions li
sted in the ICD
and in this prot
ocol
Crit
erio
n me
t?:YESInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851329
Page 102 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN04A00
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851330
Page 103 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.d Inclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving per
sonal signed informed
consent, which includ
es compliance with th
e requirements and res
trictions listed in the I
CD and in this protoc
olInitial Entry
1.d Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851331
Page 104 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:1
Crit
erio
n De
scri
ptio
n:Other medical
or psychiatric c
ondition incl. re
cent (within pas
t year) or active
suicidal ideatio
n/behavior/lab
abnormality tha
t may increase t
he risk of study
participation
Crit
erio
n m
et?:NOInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851332
Page 105 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psyc
hiatric condition incl.
recent (within past ye
ar) or active suicidal i
deation/behavior/lab a
bnormality that may i
ncrease the risk of stu
dy participationInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851333
Page 106 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.a Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:2Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851334
Page 107 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crite
rion
Descr
iptio
n:Known infecti
on with huma
n immunodefi
ciency virus (
HIV), hepatiti
s C virus (HC
V), or hepatiti
s B virus (HB
V)
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX02A00
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851335
Page 108 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.b Exclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection with
human immunodeficie
ncy virus (HIV), hepat
itis C virus (HCV), or
hepatitis B virus (HB
V)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851336
Page 109 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:3
Crit
erio
n De
scrip
tion:History of seve
re adverse react
ion associated
with a vaccine
and/or severe a
llergic reaction
(eg, anaphylaxi
s) to any comp
onent of the stu
dy intervention
(s)
Crit
erio
n me
t?:NOInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851337
Page 110 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX03A00
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851338
Page 111 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.c Exclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adve
rse reaction associated
with a vaccine and/or
severe allergic reactio
n (eg, anaphylaxis) to
any component of the
study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851339
Page 112 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:4
Criterio
n Descri
ption:Receipt of
medications
intended to
prevent CO
VID-19
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX04A00Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851340
Page 113 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.d Exclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medication
s intended to prevent
COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851341
Page 114 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.e
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:8
Crit
erio
n De
scrip
tion:Immunocompr
omised individ
uals with know
n or suspected i
mmunodeficie
ncy, as determi
ned by history
and/or laborato
ry/physical exa
mination
Crit
erio
n me
t?:NOInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851342
Page 115 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX08A00
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851343
Page 116 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.e Exclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised
individuals with know
n or suspected immun
odeficiency, as determ
ined by history and/or
laboratory/physical ex
aminationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851344
Page 117 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:10
Crit
erio
n De
scrip
tion:Bleeding diath
esis or conditio
n associated wi
th prolonged bl
eeding that wo
uld, in the opin
ion of the inves
tigator, contrai
ndicate intramu
scular injection
Crit
erio
n me
t?:NOInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851345
Page 118 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX10A00
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851346
Page 119 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.f Exclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or
condition associated
with prolonged bleedi
ng that would, in the o
pinion of the investiga
tor, contraindicate intr
amuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851347
Page 120 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numbe
r:11
Criterio
n Descri
ption:Women w
ho are pre
gnant or br
eastfeedin
g
Criterio
n met?:NO
Criterio
n ID: (Fo
r Pfizer
use only)
:EX11A00Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851348
Page 121 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.g Exclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are pregn
ant or breastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851349
Page 122 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.h
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:12
Criterio
n Descri
ption:Previous va
ccination w
ith any cor
onavirus va
ccine
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX12A00Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851350
Page 123 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.h Exclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccination
with any coronavirus
vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851351
Page 124 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.i
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:13
Crite
rion
Descr
iption
:Subjects who
receive immu
nosuppressive
therapy, such
as cytotoxic a
gents or syste
mic corticoste
roids
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX13A01Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851352
Page 125 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.i Exclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive i
mmunosuppressive th
erapy, such as cytotox
ic agents or systemic c
orticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851353
Page 126 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:15
Crit
erio
n De
scrip
tion:Receipt of bloo
d/plasma produ
cts or immunog
lobulin, from 6
0 days before s
tudy interventi
on administrati
on or planned r
eceipt througho
ut the study
Crit
erio
n me
t?:NOInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851354
Page 127 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX14A01
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851355
Page 128 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.j Exclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plas
ma products or immu
noglobulin, from 60 d
ays before study inter
vention administration
or planned receipt thr
oughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851356
Page 129 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851357
Page 130 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
2.k
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:16
Crite
rion
Desc
ripti
on:Participation i
n other studies
involving stud
y intervention
within 28 days
prior to study
entry and/or d
uring study pa
rticipation
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX15A01Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851358
Page 131 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.k Exclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other
studies involving stud
y intervention within
28 days prior to study
entry and/or during st
udy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851359
Page 132 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:17
Crite
rion
Descr
iption
:Previous parti
cipation in ot
her studies in
volving study
intervention c
ontaining lipi
d nanoparticl
es
Crite
rion
met?:NOInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851360
Page 133 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX16A01
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851361
Page 134 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.l Exclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participation
in other studies invol
ving study interventio
n containing lipid nan
oparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851362
Page 135 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:22
Crit
erio
n D
escr
iptio
n:Investigator sit
e staff or Pfizer
employees dire
ctly involved in
the conduct of t
he study, site st
aff otherwise s
upervised by th
e investigator,
and their respe
ctive family me
mbers
Crit
erio
n m
et?:NOInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851363
Page 136 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX21A01
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851364
Page 137 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.m Exclusion Number:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff
or Pfizer employees d
irectly involved in the
conduct of the study,
site staff otherwise su
pervised by the invest
igator, and their respe
ctive family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851365
Page 138 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-07-2020
15:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851366
Page 139 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-07-2020
15:55:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-07-2020
15:55:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-07-2020
15:55:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851367
Page 140 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Sep-07-2020
15:55:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical
History T
erm:Systemic ar
terial hyper
tension
Start Dat
e:UNK/UNK
/2010
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-07-2020
15:55:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020
15:55:23
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Systemic arterial hype
rtensionInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851368
Page 141 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
1.a Start Date:
Date Location User Value Reason
Sep-07-2020
15:55:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-07-2020
15:55:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-07-2020
15:55:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Overwei
ght
Start Date: UNK/U
NK/200
0
Ongoing: YESInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851369
Page 142 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Line/MH Number:
Date Location User Value Reason
Sep-07-2020
15:55:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020
15:55:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OverweightInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-07-2020
15:55:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-07-2020
15:55:46
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(
 
FDA-CBER-2021-5683-0851370
Page 143 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851371
Page 144 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-07-2020
15:56:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-07-2020
15:56:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
97.1Initial Entry
3. Unit:
Date Location User Value Reason
Sep-07-2020
15:56:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851372
Page 145 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
15:56:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
175.8Initial Entry
5. Unit:
Date Location User Value Reason
Sep-07-2020
15:56:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-07-2020
15:56:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.4Initial Entry
7.a
Date Location User Value Reason
Sep-07-2020
15:56:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Iden
tifier::1
Temperatur
e:36.3Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851373
Page 146 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Temperatur
e Unit:C
Temperatur
e Location::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Sep-07-2020
15:56:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-07-2020
15:56:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.3Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-07-2020
15:56:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851374
Page 147 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-07-2020
15:56:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851375
Page 148 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-07-2020
15:56:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-07-2020
15:56:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
83035Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851376
Page 149 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020
17:45:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020
17:45:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020
17:45:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-07-2020
17:45:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851377
Page 150 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Sep-07-2020
17:45:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/7/2020Initial Entry
5.a
Date Location User Value Reason
Sep-07-2020
17:45:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPHNX
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-07-2020
17:45:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPHNXFInitial Entry
5.b
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851378
Page 151 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
17:45:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPHNX
GInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-07-2020
17:45:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPHNXGInitial Entry
5.c
Date Location User Value Reason
Sep-07-2020
17:45:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPTJR
TInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-07-2020
17:45:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTJRTInitial Entry
5.d
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851379
Page 152 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-07-2020
17:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPTJR
VInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-07-2020
17:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTJRVInitial Entry
5.e
Date Location User Value Reason
Sep-07-2020
17:46:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPTJR
WInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-07-2020
17:46:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTJRWInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851380
Page 153 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020
17:20:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020
17:20:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020
17:20:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-07-2020
17:20:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851381
Page 154 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Sep-07-2020
17:20:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/7/2020Initial Entry
5.a
Date Location User Value Reason
Sep-07-2020
17:20:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPTJT
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-07-2020
17:20:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTJTCInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851382
Page 155 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-07-2020
15:57:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-07-2020
15:57:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-07-2020
15:57:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-07-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851383
Page 156 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
15:57:16
(UTC-03:00) City
of Buenos AiresSep/7/2020 10:26
5. Anatomical Location:
Date Location User Value Reason
Sep-07-2020
15:57:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-07-2020
15:57:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-07-2020
15:57:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851384
Page 157 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
15:57:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-07-2020
15:57:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851385
Page 158 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-07-2020
15:57:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851386
Page 159 of 202
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-29-2020
14:00:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851387
Page 160 of 202
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-29-2020
14:01:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
2.a
Date Location User Value Reason
Sep-29-2020
14:01:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.5
Temperatu
re Unit:C
Temperatu
re Location
::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-29-2020
14:01:08
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851388
Page 161 of 202
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.a Temperature:
Date Location User Value Reason
Sep-29-2020
14:01:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-29-2020
14:01:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-29-2020
14:01:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851389
Page 162 of 202
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020
17:45:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020
17:45:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020
17:45:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-29-2020
17:45:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851390
Page 163 of 202
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Sep-29-2020
17:45:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/29/2020Initial Entry
5.a
Date Location User Value Reason
Sep-29-2020
17:45:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP7XH
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020
17:45:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP7XHBInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851391
Page 164 of 202
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-29-2020
14:01:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-29-2020
14:01:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-29-2020
14:01:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-29-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851392
Page 165 of 202
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
14:01:38
(UTC-03:00) City
of Buenos AiresSep/29/2020 10:26
5. Anatomical Location:
Date Location User Value Reason
Sep-29-2020
14:01:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-29-2020
14:01:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-29-2020
14:01:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851393
Page 166 of 202
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-29-2020
14:01:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-29-2020
14:01:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851394
Page 167 of 202
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-27-2020
09:44:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851395
Page 168 of 202
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020
17:22:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020
17:22:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020
17:22:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-27-2020
17:22:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851396
Page 169 of 202
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Oct-27-2020
17:22:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020
17:22:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BS85F
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-27-2020
17:22:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS85FZInitial Entry
5.b
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0851397
Page 170 of 202
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-27-2020
17:22:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BS85G
0Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-27-2020
17:22:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS85G0Initial Entry
5.c
Date Location User Value Reason
Oct-27-2020
17:22:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BR786
4Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-27-2020
17:22:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR7864Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851398
Page 171 of 202
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-23-2021
11:25:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/23/2021Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851399
Page 172 of 202
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-23-2021
17:04:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-23-2021
17:04:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-23-2021
17:04:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-23-2021
17:04:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851400
Page 173 of 202
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Mar-23-2021
17:04:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Mar/23/2021Initial Entry
5.a
Date Location User Value Reason
Mar-23-2021
17:04:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRGDR
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-23-2021
17:04:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRGDR8Initial Entry
5.b
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851401
Page 174 of 202
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Mar-23-2021
17:05:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BSCX6
VInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-23-2021
17:05:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BSCX6VInitial Entry
5.c
Date Location User Value Reason
Mar-23-2021
17:05:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BSCX6
WInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-23-2021
17:05:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BSCX6WInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851402
Page 175 of 202
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-27-2020
09:46:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-27-2020
09:46:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-27-2020
09:46:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851403
Page 176 of 202
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-23-2021
10:20:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/21/2021Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851404
Page 177 of 202
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-23-2021
10:21:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-23-2021
10:20:59
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-23-2021
10:20:59
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible and N
OT confirmed tInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851405
Page 178 of 202
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
o have received
only placebo at
Vaccination 1/2
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851406
Page 179 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Sep-29-2020
14:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851407
Page 180 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Oct-27-2020
09:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851408
Page 181 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851409
Page 182 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Sep-29-2020
14:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-29-2020
14:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-29-2020
14:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Pain at the injection
siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851410
Page 183 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-29-2020
14:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/7/2020 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-29-2020
14:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/8/2020 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-29-2020
14:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851411
Page 184 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-29-2020
14:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-29-2020
14:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-29-2020
14:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-29-2020
14:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851412
Page 185 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-29-2020
14:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-29-2020
14:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-29-2020
14:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-29-2020
14:04:03
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851413
Page 186 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851414
Page 187 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020
09:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020
09:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-27-2020
09:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Pain at the injection
siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851415
Page 188 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-27-2020
09:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/30/2020 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-27-2020
09:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/30/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-27-2020
09:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851416
Page 189 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Oct-27-2020
09:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-27-2020
09:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-27-2020
09:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-27-2020
09:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851417
Page 190 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-27-2020
09:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-27-2020
09:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-27-2020
09:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020
09:47:35
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851418
Page 191 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851419
Page 192 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Left ureteral stoneInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851420
Page 193 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/13/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/15/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851421
Page 194 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Nov-26-2020
08:29:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Left
ureteral
stone:
Response to
"Is the
adverse event
serious?" is
'Yes' but
"Serious
Adverse
Event
Number" is
blank.
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious eve
nt associated with
congenital anomal
y or birth defect?
NO
Did this serious ev
ent result in death?Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851422
Page 195 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
NO
Did this serious ev
ent require or prol
ong hospitalizatio
n?
YES
Did this serious ev
ent result in persist
ent or significant d
isability/incapacit
y?
NO
Is this serious eve
nt life threatening?
NO
Other medically i
mportant serious e
vent
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851423
Page 196 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), th
is event is due to:
OTHER
If Other, specify
:
UnknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851424
Page 197 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-18-2020
16:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851425
Page 198 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-26-2020
08:29:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2020457143Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851426
Page 199 of 202
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-23-2021
10:21:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/21/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-23-2021
10:21:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851427
Page 200 of 202
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-27-2020
09:46:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-07-2020
15:56:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-07-2020
15:55:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-27-2020
09:46:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/27/2020Initial Entry
Sep-07-2020
15:56:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/7/2020Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851428
Page 201 of 202
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
15:55:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/7/2020Initial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851429
Page 202 of 202
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-02-2020
19:30:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae4053\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851430