125742 S1 M5 CRF c4591001 1226 12261282

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
140
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 140
***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: 12261282 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
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849298
Page 2 of 140
***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: 12261282 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
Aug/19/2020
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849299
Page 3 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12261282]
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:
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849300
Page 4 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849301
Page 5 of 140
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 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: 12261282 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
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
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849302
Page 6 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 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: 12261282 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
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
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849303
Page 7 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 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: 12261282 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
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
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849304
Page 8 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849305
Page 9 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[obesity]
Start Date: UNK/UNK/2012
Ongoing: YES
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849306
Page 10 of 140
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
2.Weight: [102.0]
3.Unit: kg
4.Height: [178.3]
5.Unit: cm
6.Body Mass Index: [32.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849307
Page 11 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/19/2020
2.Randomization Number: [55707]
3.Randomization Group: [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849308
Page 12 of 140
***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: 12261282 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:
Aug/19/2020
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 [BP5TRH]
5.bSample ID [BP5TRG]
5.cSample ID [BP5TRF]
5.dSample ID [BLCJ4K]
5.eSample ID [BLCJ4J]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849309
Page 13 of 140
***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: 12261282 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:
Aug/19/2020
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 [BP5TSC]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849310
Page 14 of 140
***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: 12261282 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: Aug/19/2020 10:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849311
Page 15 of 140
***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: 12261282 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
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849312
Page 16 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849313
Page 17 of 140
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849314
Page 18 of 140
***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: 12261282 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/10/2020
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 [BPWVCX]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849315
Page 19 of 140
***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: 12261282 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/10/2020 10:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849316
Page 20 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849317
Page 21 of 140
***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: 12261282 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/26/2020
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 [BR6NSD]
5.bSample ID [BS85DS]
5.cSample ID [BS85DR]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849318
Page 22 of 140
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/16/2021
2.Erroneous Visit
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849319
Page 23 of 140
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_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: 12261282 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/16/2021
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 [BRGZ78]
5.bSample ID [BRXWCD]
5.cSample ID [BRXWCC]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849320
Page 24 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849321
Page 25 of 140
***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: 12261282 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 [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849322
Page 26 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849323
Page 27 of 140
***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: 12261282 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 [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849324
Page 28 of 140
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12261282 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:
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849325
Page 29 of 140
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12261282 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: [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849326
Page 30 of 140
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12261282 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 [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849327
Page 31 of 140
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12261282 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 [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849328
Page 32 of 140
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12261282 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?
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849329
Page 33 of 140
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12261282 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:
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849330
Page 34 of 140
***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: 12261282 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:
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849331
Page 35 of 140
***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: 12261282 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 [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849332
Page 36 of 140
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849333
Page 37 of 140
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849334
Page 38 of 140
***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: 12261282 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/26/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849335
Page 39 of 140
***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: 12261282 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: [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849336
Page 40 of 140
***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: 12261282 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:
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849337
Page 41 of 140
***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: 12261282 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 [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849338
Page 42 of 140
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849339
Page 43 of 140
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 12261282 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:
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849340
Page 44 of 140
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 12261282 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?
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849341
Page 45 of 140
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849342
Page 46 of 140
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849343
Page 47 of 140
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849344
Page 48 of 140
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849345
Page 49 of 140
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 12261282 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 [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849346
Page 50 of 140
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 12261282 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 [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849347
Page 51 of 140
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/30/2021
2.Erroneous Visit
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849348
Page 52 of 140
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 12261282 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
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849349
Page 53 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Identifie
rAdverse Eve
ntStart DateIs the Adverse Event Still Ongoi
ngForm Instance
 1.ADVERSE EVEN
T 1  Appendicitis  Oct/1/2020 UNK:UN
K NO
End Date Time:
Oct/3/2020 UNK:UNK
 Repeating Pages
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849350
Page 54 of 140
***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: 12261282 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)[Appendicitis]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/3/2020 UNK:UNK
6.Toxicity Grade: 3
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
YES
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:
[cause: alimentary]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849351
Page 55 of 140
***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: 12261282 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? YES
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[2020415072]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849352
Page 56 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849353
Page 57 of 140
***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: 12261282 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[ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849354
Page 58 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849355
Page 59 of 140
***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: 12261282 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: //
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849356
Page 60 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849357
Page 61 of 140
***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: 12261282 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?
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849358
Page 62 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849359
Page 63 of 140
***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: 12261282 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?
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849360
Page 64 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849361
Page 65 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849362
Page 66 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849363
Page 67 of 140
***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: 12261282 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?
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849364
Page 68 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/1/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849365
Page 69 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849366
Page 70 of 140
***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: 12261282 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: [ ]
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849367
Page 71 of 140
***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: 12261282 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/26/2020
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849368
Page 72 of 140
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12261282 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
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849369
Page 73 of 140
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12261282 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-18-2021 11:04:43 (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.
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849370
Page 74 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormAug-24-2020 11:38:34 (UTC-03:00) City of Buenos
Aires
FormAug-19-2020 17:16:21 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849371
Page 75 of 140
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12261282 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-18-2021 11:04:43 (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-16-2021 17:04:12 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Mar-16-2021 15:18:49 (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-16-2021 13:39:48 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Feb-10-2021 17:58:56 (UTC-03:00) City of Buenos
AiresBOOK Signed
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849372
Page 76 of 140
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12261282 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 Feb-03-2021 10:55:57 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Nov-05-2020 16:13:27 (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.
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849373
Page 77 of 140
***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: 12261282 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
Aug-19-2020 17:14:42
(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
Aug-19-2020 17:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0849374
Page 78 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-19-2020 17:14:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/19/2020Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849375
Page 79 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-19-2020 17:14:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12261282Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-19-2020 17:14:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1985Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-19-2020 17:14:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-19-2020 17:14:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-19-2020 17:14:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849376
Page 80 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-19-2020 17:15:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849377
Page 81 of 140
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants
between the ages of 18 and 5
5 years, inclusive, 65 and 85
years, inclusive, or 18 and 8
5 years, inclusive, at random
ization (dependent upon stud
y stage)
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female participants between t
he ages of 18 and 55 years, inclusive,
65 and 85 years, inclusive, or 18 and
85 years, inclusive, at randomization
(dependent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849378
Page 82 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willing
and able to comply with all
scheduled visits, vaccinatio
n plan, laboratory tests, lifes
tyle considerations, and oth
er study procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only):IN02A00Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849379
Page 83 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Inclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are willing and able
to comply with all scheduled visits, v
accination plan, laboratory tests, lifes
tyle considerations, and other study p
roceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who ar
e determined by medical his
tory, physical examination,
and clinical judgment of the
investigator to be eligible fo
r inclusion in the studyInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0849380
Page 84 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants who are determi
ned by medical history, physical exa
mination, and clinical judgment of th
e investigator to be eligible for inclus
ion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
Inclusi4Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849381
Page 85 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires on Nu
mber:
Criteri
on Des
criptio
n:Capable of giving personal
signed informed consent, w
hich includes compliance w
ith the requirements and res
trictions listed in the ICD a
nd in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN04A00
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849382
Page 86 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.d Inclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving personal signed inf
ormed consent, which includes compl
iance with the requirements and restri
ctions listed in the ICD and in this pr
otocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatric
condition incl. recent (withi
n past year) or active suicida
l ideation/behavior/lab abno
rmality that may increase th
e risk of study participationInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849383
Page 87 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psychiatric conditio
n incl. recent (within past year) or act
ive suicidal ideation/behavior/lab abn
ormality that may increase the risk of
study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
Exclusio 2Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849384
Page 88 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires n Numbe
r:
Criterio
n Descri
ption:Known infection with hu
man immunodeficiency vi
rus (HIV), hepatitis C viru
s (HCV), or hepatitis B vi
rus (HBV)
Criterio
n met?:NO
Criterio
n ID: (Fo
r Pfizer
use only)
:EX02A00
2.b Exclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection with human immun
odeficiency virus (HIV), hepatitis C v
irus (HCV), or hepatitis B virus (HB
V)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849385
Page 89 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse re
action associated with a vac
cine and/or severe allergic r
eaction (eg, anaphylaxis) to
any component of the study
intervention(s)
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX03A00Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849386
Page 90 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.c Exclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adverse reaction ass
ociated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to
any component of the study interventi
on(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:4
Criterion Des
cription:Receipt of medicatio
ns intended to preve
nt COVID-19
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX04A00Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849387
Page 91 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.d Exclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medications intended to pr
event COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:8
Criteri
on Desc
ription:Immunocompromised indiv
iduals with known or suspe
cted immunodeficiency, as
determined by history and/
or laboratory/physical exa
mination
Criteri
on met?
:NOInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849388
Page 92 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on ID: (
For Pfi
zer use
only):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised individuals wit
h known or suspected immunodeficie
ncy, as determined by history and/or l
aboratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:10Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849389
Page 93 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on Desc
ription:Bleeding diathesis or condit
ion associated with prolong
ed bleeding that would, in t
he opinion of the investigat
or, contraindicate intramusc
ular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition associ
ated with prolonged bleeding that wo
uld, in the opinion of the investigator,
contraindicate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849390
Page 94 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Num
ber:11
Criterion Descr
iption:Women who are pr
egnant or breastfee
ding
Criterion met?: NO
Criterion ID: (
For Pfizer use o
nly):EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are pregnant or breastfe
edingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
Exclusion Nu 12Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0849391
Page 95 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires mber:
Criterion Desc
ription:Previous vaccinatio
n with any coronavi
rus vaccine
Criterion met
?:NO
Criterion ID: (
For Pfizer use
only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccination with any corona
virus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:13Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0849392
Page 96 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterion
Descripti
on:Subjects who receive im
munosuppressive therapy
, such as cytotoxic agents
or systemic corticosteroid
s
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive immunosuppres
sive therapy, such as cytotoxic agents
or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
Exclusi15Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0849393
Page 97 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires on Nu
mber:
Criteri
on Desc
ription:Receipt of blood/plasma pr
oducts or immunoglobulin,
from 60 days before study i
ntervention administration
or planned receipt througho
ut the study
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX14A01
2.j Exclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products or i
mmunoglobulin, from 60 days before
study intervention administration or p
lanned receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849394
Page 98 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
2.k
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other studi
es involving study interve
ntion within 28 days prior
to study entry and/or durin
g study participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX15A01Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849395
Page 99 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.k Exclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other studies involvi
ng study intervention within 28 days
prior to study entry and/or during stu
dy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:17
Criterion
Descripti
on:Previous participation in
other studies involving st
udy intervention containi
ng lipid nanoparticles
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX16A01Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849396
Page 100 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.l Exclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participation in other studie
s involving study intervention contai
ning lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:22
Criteri
on Des
criptio
n:Investigator site staff or Pfiz
er employees directly invol
ved in the conduct of the stu
dy, site staff otherwise super
vised by the investigator, an
d their respective family me
mbers
Criteri
on met
?:NOInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849397
Page 101 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on ID:
(For P
fizer u
se only
):EX21A01
2.m Exclusion Number:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer emplo
yees directly involved in the conduct
of the study, site staff otherwise supe
rvised by the investigator, and their r
espective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 17:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849398
Page 102 of 140
***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: 12261282 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
Aug-19-2020 17:15:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-19-2020 17:15:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-19-2020 17:15:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849399
Page 103 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Aug-24-2020 11:39:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:obesity
Start Date: UNK/UNK/20
12
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-24-2020 11:39:13
(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
Aug-24-2020 11:39:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
obesityInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-24-2020 11:39:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-24-2020 11:39:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849400
Page 104 of 140
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Aug-19-2020 17:17:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-19-2020 17:17:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
102.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-19-2020 17:17:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-19-2020 17:17:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
178.3Initial Entry
5. Unit:
Date Location User Value Reason
Aug-19-2020 17:17:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-19-2020 17:17:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.1Initial Entry
7.a
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849401
Page 105 of 140
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-19-2020 17:17:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Locatio
n::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-19-2020 17:17:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-19-2020 17:17:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-19-2020 17:17:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-19-2020 17:17:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849402
Page 106 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-19-2020 17:17:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-19-2020 17:17:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
55707Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0849403
Page 107 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 17:43:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 17:43:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020 17:43:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 17:43:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-19-2020 17:43:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 17:43:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP5TRHInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849404
Page 108 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-19-2020 17:43:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP5TRHInitial Entry
5.b
Date Location User Value Reason
Aug-19-2020 17:43:15
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP5TRGInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-19-2020 17:43:15
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP5TRGInitial Entry
5.c
Date Location User Value Reason
Aug-19-2020 17:43:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP5TRFInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-19-2020 17:43:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP5TRFInitial Entry
5.d
Date Location User Value Reason
Aug-19-2020 17:43:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLCJ4KInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-19-2020 17:43:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BLCJ4KInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0849405
Page 109 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.e
Date Location User Value Reason
Aug-19-2020 17:43:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLCJ4JInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-19-2020 17:43:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BLCJ4JInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849406
Page 110 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 17:44:36
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 17:44:36
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020 17:44:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 17:44:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-19-2020 17:44:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 17:44:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP5TSCInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0849407
Page 111 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-19-2020 17:44:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP5TSCInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849408
Page 112 of 140
***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: 12261282 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
Aug-19-2020 17:18:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-19-2020 17:18:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-19-2020 17:18:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-19-2020 17:18:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/19/2020 10:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-19-2020 17:18:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-19-2020 17:18:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849409
Page 113 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-19-2020 17:18:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-19-2020 17:18:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-19-2020 17:18:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849410
Page 114 of 140
***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: 12261282 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
Aug-19-2020 17:18:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849411
Page 115 of 140
***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: 12261282 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-10-2020 12:36:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849412
Page 116 of 140
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020 12:36:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2.a
Date Location User Value Reason
Sep-10-2020 12:36:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Location
::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-10-2020 12:36:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-10-2020 12:36:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-10-2020 12:36:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-10-2020 12:36:34
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849413
Page 117 of 140
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849414
Page 118 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 15:35:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 15:35:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 15:35:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-10-2020 15:35:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-10-2020 15:35:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020 15:35:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPWVCXInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849415
Page 119 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-10-2020 15:35:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPWVCXInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849416
Page 120 of 140
***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: 12261282 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-10-2020 12:37:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020 12:37:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020 12:37:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020 12:37:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/10/2020 10:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020 12:37:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-10-2020 12:37:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849417
Page 121 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-10-2020 12:37:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020 12:37:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-10-2020 12:37:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849418
Page 122 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-05-2020
04:57:04
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies query
Nov-04-2020
14:08:50
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Ans
weredThe SI contacted the subject,
that informed the symptom
was "throat discomfort", and
not "sore throat", and the SI
considered not clinically
significant and judged not
necessary a COVID ILLNESS
VISIT.
Nov-02-2020
13:55:48
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Op
enedIllness ediary: As per Illness
ediary records, subject
reported "Yes" for the question
"Have you experienced any of
the following?” for the
COVID-19 symptoms or
diagnosis on 21OCT2020. But
corresponding COVID Illness
visit not reported. Please
clarify.
Oct-28-2020
04:55:00
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Clo
sedAs per site confirmation -
updated PD tracker
Oct-27-2020
12:06:33
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Ans
weredThe date is correct and it
happens because of subject
own issues.
Oct-27-2020
02:43:06
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 11 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0849419
Page 123 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
appropriately. 
Oct-26-2020
12:55:28
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Oct/2
6/202
0Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0849420
Page 124 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020 16:59:25
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020 16:59:25
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-26-2020 16:59:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-26-2020 16:59:25
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-26-2020 16:59:25
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/26/2020Initial Entry
5.a
Date Location User Value Reason
Oct-26-2020 16:59:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR6NSDInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849421
Page 125 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-26-2020 16:59:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BR6NSDInitial Entry
5.b
Date Location User Value Reason
Oct-26-2020 17:00:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS85DSInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-26-2020 17:00:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BS85DSInitial Entry
5.c
Date Location User Value Reason
Oct-26-2020 17:00:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS85DRInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-26-2020 17:00:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BS85DRInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849422
Page 126 of 140
***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, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261282 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-16-2021 13:39:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Mar/16/2021Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849423
Page 127 of 140
***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, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-16-2021 17:04:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-16-2021 17:04:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-16-2021 17:04:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-16-2021 17:04:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Mar-16-2021 17:04:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/16/2021Initial Entry
5.a
Date Location User Value Reason
Mar-16-2021 17:04:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRGZ78Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849424
Page 128 of 140
***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, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Mar-16-2021 17:04:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BRGZ78Initial Entry
5.b
Date Location User Value Reason
Mar-16-2021 17:04:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRXWCDInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-16-2021 17:04:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BRXWCDInitial Entry
5.c
Date Location User Value Reason
Mar-16-2021 17:04:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRXWCCInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-16-2021 17:04:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BRXWCCInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849425
Page 129 of 140
***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: 12261282 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-26-2020 14:53:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-26-2020 14:53:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-26-2020 14:53:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849426
Page 130 of 140
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021 10:55:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/30/2021Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849427
Page 131 of 140
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 12261282 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
Feb-03-2021 10:56:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-03-2021 10:56:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Feb-03-2021 10:56:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing to return for Va
ccination 3
Participant is:
eligible and NOT confirmed to ha
ve received only placebo at Vacci
nation 1/2Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849428
Page 132 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Oct-26-2020 13:01:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849429
Page 133 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Oct-26-2020 13:01:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-26-2020 13:01:56
(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
Nov-04-2020 10:58:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Appreciate the prompt
response. Thank you.
Nov-03-2020 17:30:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered SARS-CoV-2 test not
done. FUP will be
send
Nov-01-2020 23:05:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Kindly confirm if any
SARS-CoV-2 (NAAT
or other) tests were
performed on the SAE
submitted to safety. If
test performed = YES,
please provide FU
report with results. If
test was NOT done or
NOT available, please
FU as well. Thanks
Oct-26-2020 13:01:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
AppendicitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-26-2020 13:01:56
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry:
Oct/1/2020 UNK:UNKInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0849430
Page 134 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aires
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-26-2020 13:01:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/3/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-26-2020 13:01:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
3Initial 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).
Date Location User Value Reason
Nov-02-2020 14:58:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 3: Closed Thank you.
Oct-30-2020 16:51:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Answered This information will
be included in the next
follow up
Oct-30-2020 16:34:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 3: Reissued:Opened If test was NOT done
or NOT available,
please summit FU
report so this
information is added to
the case narrative as
well. Thanks
Oct-30-2020 07:44:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Answered Any SARS-CoV-2 test
were performed
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0849431
Page 135 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-29-2020 21:27:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 3: Opened Kindly confirm if any
SARS-CoV-2 (NAAT
or other) tests were
performed on the SAE
report submitted to
safety. If test performed
= YES, please provide
FU report with results.
If test was NOT done
or NOT available,
please FU as well.
Thanks
Oct-28-2020 05:56:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed SDB updated
Oct-28-2020 00:03:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Reissued:Candidate to check next SAE
listing
Oct-27-2020 14:58:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered FAX transmitted in
26oct2020
Oct-27-2020 08:06:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened SAE RECON:
Appendicitis(Onset
date:01Oct2020) is not
reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event on
AE CRF
Oct-27-2020 08:05:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Deleted Query can be addressed
internally
Oct-26-2020 13:01:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Appendicitis:
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event
Number" is blank.
Oct-26-2020 13:01:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated withInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849432
Page 136 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
congenital anomaly or birth defect?
NO
Did this serious event result in deat
h?
NO
Did this serious event require or pr
olong hospitalization?
YES
Did this serious event result in pers
istent or significant disability/incap
acity?
NO
Is this serious event life threatening
?
NO
Other medically important serious e
vent
YES
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-26-2020 13:01:56
(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-26-2020 13:01:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849433
Page 137 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
cause: alimentary
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-26-2020 13:01:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-26-2020 13:01:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-26-2020 13:01:56
(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
Oct-26-2020 13:01:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-26-2020 13:01:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-28-2020 05:56:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2020415072Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0849434
Page 138 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-03-2021 10:56:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/1/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-03-2021 10:56:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADDIT
IONAL VACCINATIONInitial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849435
Page 139 of 140
***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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-26-2020 14:53:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-19-2020 17:17:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-19-2020 17:15:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-26-2020 14:53:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/26/2020Initial Entry
Aug-19-2020 17:17:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
Aug-19-2020 17:15:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849436
Page 140 of 140
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12261282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-05-2020 16:12:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
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090177e196ae4064\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849437
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