125742 S1 M5 CRF c4591001 1226 12261707

Document text

Page 1 of 215
***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: 12261707 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
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852285
Page 2 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/14/2020
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852286
Page 3 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12261707]
2.Birth Date: 1993
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852287
Page 4 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852288
Page 5 of 215
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 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
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852289
Page 6 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
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
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852290
Page 7 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852291
Page 8 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852292
Page 9 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852293
Page 10 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852294
Page 11 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852295
Page 12 of 215
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
2.Weight: [63.8]
3.Unit: kg
4.Height: [170.8]
5.Unit: cm
6.Body Mass Index: [21.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852296
Page 13 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/14/2020
2.Randomization Number: [89392]
3.Randomization Group: [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852297
Page 14 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
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 [BP7K08]
5.bSample ID [BP7K07]
5.cSample ID [BP7K06]
5.dSample ID [BLBPRM]
5.eSample ID [BLBPRL]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852298
Page 15 of 215
***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: 12261707 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/14/2020
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 [BPWV0T]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852299
Page 16 of 215
***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: 12261707 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/14/2020 12:00
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
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852300
Page 17 of 215
***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: 12261707 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
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852301
Page 18 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852302
Page 19 of 215
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Oct/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852303
Page 20 of 215
***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: 12261707 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:
Oct/5/2020
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 [BPVZ02]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852304
Page 21 of 215
***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: 12261707 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: Oct/5/2020 12:30
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
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852305
Page 22 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852306
Page 23 of 215
***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: 12261707 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:
Nov/3/2020
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 [BR78CS]
5.bSample ID [BS2VCH]
5.cSample ID [BS2VCJ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852307
Page 24 of 215
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852308
Page 25 of 215
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_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: 12261707 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 [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852309
Page 26 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852310
Page 27 of 215
***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: 12261707 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 [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852311
Page 28 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852312
Page 29 of 215
***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: 12261707 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 [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852313
Page 30 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: DATE OF VISIT - ILLNESS ONSET
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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852314
Page 31 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Mar/3/2021
2.Date of First Symptom Started: Feb/27/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/28/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852315
Page 32 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852316
Page 33 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Collec
tionSpecimen T
ypeSpecimen Collection L
ocationAssay Code and Desc
riptionDevice Typ
eForm Instanc
e
 1.Not Applicabl
e Not Applica
ble Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852317
Page 34 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852318
Page 35 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
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: 12261707 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_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Subject came to site to the visit, recorded at swab pfe]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852319
Page 36 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 12261707 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:
Mar/3/2021
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 [BR61BF]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852320
Page 37 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852321
Page 38 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852322
Page 39 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Treatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852323
Page 40 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852324
Page 41 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852325
Page 42 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.        Repeating Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852326
Page 43 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852327
Page 44 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852328
Page 45 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852329
Page 46 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852330
Page 47 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852331
Page 48 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Mar/3/2021 Record Identifier: Systolic: Diastolic:
1  120  80 Repeating Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852332
Page 49 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Mar/3/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [120]
Diastolic: [80]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [72]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852333
Page 50 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Mar/3/2021 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852334
Page 51 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Mar/3/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852335
Page 52 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
 1.      Repeating Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852336
Page 53 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: OXYGENATION PARAMETERS
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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852337
Page 54 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852338
Page 55 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 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.Start Date: //
6.Ongoing?
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852339
Page 56 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852340
Page 57 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: IMAGING
Form Version: 06-Jul-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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852341
Page 58 of 215
***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: 12261707 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:
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852342
Page 59 of 215
***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: 12261707 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 [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852343
Page 60 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852344
Page 61 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852345
Page 62 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852346
Page 63 of 215
***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: 12261707 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: [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852347
Page 64 of 215
***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: 12261707 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:
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852348
Page 65 of 215
***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: 12261707 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 [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852349
Page 66 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852350
Page 67 of 215
***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: 12261707 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:
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852351
Page 68 of 215
***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: 12261707 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?
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852352
Page 69 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852353
Page 70 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852354
Page 71 of 215
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852355
Page 72 of 215
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852356
Page 73 of 215
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 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 [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852357
Page 74 of 215
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 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 [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852358
Page 75 of 215
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852359
Page 76 of 215
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 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
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852360
Page 77 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  fever (37,8 C)  Oct/5/2020 20:
00 NO
End Date Time:
Oct/5/2020 UNK:UN
K
 Repeating
Pages
 2.ADVERSE E
VENT 2  axillary lymphadenopathy
in the left arm Oct/6/2020 UN
K:UNK NO
End Date Time:
Oct/8/2020 UNK:UN
K
 Repeating
Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852361
Page 78 of 215
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 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)[fever (37,8 C)]
4.Start Date Time: Oct/5/2020 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/5/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852362
Page 79 of 215
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 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?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852363
Page 80 of 215
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[axillary lymphadenopathy in the left arm]
4.Start Date Time: Oct/6/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/8/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852364
Page 81 of 215
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852365
Page 82 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852366
Page 83 of 215
***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: 12261707 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[ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852367
Page 84 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852368
Page 85 of 215
***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: 12261707 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: //
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852369
Page 86 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852370
Page 87 of 215
***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: 12261707 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?
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852371
Page 88 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852372
Page 89 of 215
***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: 12261707 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?
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852373
Page 90 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852374
Page 91 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852375
Page 92 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852376
Page 93 of 215
***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: 12261707 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?
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852377
Page 94 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/22/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852378
Page 95 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852379
Page 96 of 215
***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: 12261707 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: [ ]
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852380
Page 97 of 215
***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: 12261707 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 Nov/3/2020
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852381
Page 98 of 215
***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: 12261707 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
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852382
Page 99 of 215
***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: 12261707 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-10-2021 14:50:11 (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.
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852383
Page 100 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-15-2020 10:19:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852384
Page 101 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormMar-03-2021 15:19:10 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0852385
Page 102 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Mar-03-2021 15:19:10 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852386
Page 103 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Mar-03-2021 15:19:10 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852387
Page 104 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Mar-03-2021 15:19:10 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852388
Page 105 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Mar-03-2021 15:19:10 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852389
Page 106 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Mar-03-2021 15:19:10 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852390
Page 107 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Mar-03-2021 15:19:10 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852391
Page 108 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
7Mar-03-2021 15:19:10 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852392
Page 109 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
8Mar-03-2021 15:19:10 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852393
Page 110 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
9Mar-03-2021 15:19:10 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852394
Page 111 of 215
***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: 12261707 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-10-2021 14:50:11 (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-10-2021 07:25:04 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Mar-05-2021 11:07:09 (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-04-2021 15:50:59 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852395
Page 112 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
N/A
Cristiano
Zerbini Approved Mar-04-2021 10:03:09 (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-03-2021 15:17:37 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Feb-03-2021 18:08:33 (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 Feb-01-2021 09:24:01 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852396
Page 113 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Cristiano
Zerbini Approved Nov-16-2020 09:29:36 (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 Nov-16-2020 09:12:14 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Nov-07-2020 09:22:57 (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.
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852397
Page 114 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-15-2020 10:16:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-15-2020 10:16:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852398
Page 115 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-15-2020 10:16:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Sep/14/2020Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852399
Page 116 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-15-2020 10:02:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12261707Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-15-2020 10:02:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1993Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-15-2020 10:17:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-15-2020 10:17:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-15-2020 10:17:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852400
Page 117 of 215
***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: 12261707 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-15-2020 10:18:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852401
Page 118 of 215
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclu
sion
Num
ber:1
Crite
rion
Descr
iption
:Male or female particip
ants between the ages o
f 18 and 55 years, inclu
sive, 65 and 85 years, in
clusive, or 18 and 85 ye
ars, inclusive, at rando
mization (dependent up
on study stage)
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer us
e only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852402
Page 119 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female participants bet
ween the ages of 18 and 55 year
s, inclusive, 65 and 85 years, in
clusive, or 18 and 85 years, incl
usive, at randomization (depend
ent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion N
umbe
r:2
Criter
ion De
scripti
on:Participants who are wi
lling and able to compl
y with all scheduled vis
its, vaccination plan, la
boratory tests, lifestyle
considerations, and oth
er study proceduresInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852403
Page 120 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN02A00
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852404
Page 121 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Inclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are willing an
d able to comply with all sched
uled visits, vaccination plan, lab
oratory tests, lifestyle considera
tions, and other study procedure
sInitial Entry
1.b Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion N
umbe3Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852405
Page 122 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
r:
Criter
ion De
scripti
on:Healthy participants w
ho are determined by m
edical history, physical
examination, and clinic
al judgment of the inve
stigator to be eligible f
or inclusion in the stud
y
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852406
Page 123 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.c Inclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants who are de
termined by medical history, ph
ysical examination, and clinical
judgment of the investigator to
be eligible for inclusion in the s
tudyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion N
umbe4Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852407
Page 124 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
r:
Criter
ion De
scripti
on:Capable of giving pers
onal signed informed c
onsent, which includes
compliance with the re
quirements and restricti
ons listed in the ICD a
nd in this protocol
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN04A00
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852408
Page 125 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.d Inclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving personal sign
ed informed consent, which incl
udes compliance with the requir
ements and restrictions listed in
the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion N
umbe
r:1Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852409
Page 126 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criter
ion D
escrip
tion:Other medical or psych
iatric condition incl. rec
ent (within past year) o
r active suicidal ideatio
n/behavior/lab abnorma
lity that may increase t
he risk of study particip
ation
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psychiatric co
ndition incl. recent (within past
year) or active suicidal ideation/
behavior/lab abnormality that m
ay increase the risk of study par
ticipationInitial Entry
2.a Criterion met?
Date Location User Value Reason
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852410
Page 127 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:2
Criteri
on Desc
ription:Known infection with
human immunodefici
ency virus (HIV), hep
atitis C virus (HCV),
or hepatitis B virus (
HBV)
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX02A00Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852411
Page 128 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.b Exclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection with human i
mmunodeficiency virus (HIV),
hepatitis C virus (HCV), or hep
atitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion N
umber
:3Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852412
Page 129 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criter
ion De
scripti
on:History of severe adver
se reaction associated
with a vaccine and/or s
evere allergic reaction
(eg, anaphylaxis) to an
y component of the stu
dy intervention(s)
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX03A00
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852413
Page 130 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.c Exclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adverse reacti
on associated with a vaccine an
d/or severe allergic reaction (eg,
anaphylaxis) to any component
of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:4Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852414
Page 131 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterion D
escription:Receipt of medic
ations intended to
prevent COVID-
19
Criterion m
et?:NO
Criterion I
D: (For Pfiz
er use only)
:EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medications intende
d to prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852415
Page 132 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.e
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:8
Criteri
on Des
criptio
n:Immunocompromised
individuals with know
n or suspected immuno
deficiency, as determin
ed by history and/or la
boratory/physical exa
mination
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX08A00Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852416
Page 133 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.e Exclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised individua
ls with known or suspected im
munodeficiency, as determined
by history and/or laboratory/ph
ysical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852417
Page 134 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criter
ion De
scripti
on:Bleeding diathesis or c
ondition associated wit
h prolonged bleeding t
hat would, in the opini
on of the investigator,
contraindicate intramu
scular injection
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX10A00
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852418
Page 135 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.f Exclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition
associated with prolonged bleed
ing that would, in the opinion o
f the investigator, contraindicate
intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:11Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0852419
Page 136 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterion De
scription:Women who ar
e pregnant or br
eastfeeding
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are pregnant or bre
astfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0852420
Page 137 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion N
umber:12
Criterion D
escription:Previous vaccina
tion with any cor
onavirus vaccine
Criterion m
et?:NO
Criterion I
D: (For Pfiz
er use only):EX12A00Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0852421
Page 138 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.h Exclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccination with any c
oronavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:13Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0852422
Page 139 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterio
n Descri
ption:Subjects who receive
immunosuppressive t
herapy, such as cytot
oxic agents or system
ic corticosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX13A01
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852423
Page 140 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.i Exclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive immunos
uppressive therapy, such as cyto
toxic agents or systemic cortico
steroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:15Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0852424
Page 141 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criter
ion De
scripti
on:Receipt of blood/plasm
a products or immunog
lobulin, from 60 days b
efore study interventio
n administration or pla
nned receipt throughou
t the study
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX14A01
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852425
Page 142 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.j Exclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma produc
ts or immunoglobulin, from 60
days before study intervention a
dministration or planned receipt
throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0852426
Page 143 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
2.k
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:16
Criteri
on Des
criptio
n:Participation in other
studies involving stud
y intervention within
28 days prior to study
entry and/or during st
udy participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX15A01Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0852427
Page 144 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.k Exclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other studies in
volving study intervention with
in 28 days prior to study entry a
nd/or during study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:17Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0852428
Page 145 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterio
n Descri
ption:Previous participatio
n in other studies inv
olving study interve
ntion containing lipi
d nanoparticles
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX16A01
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852429
Page 146 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.l Exclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participation in other
studies involving study interve
ntion containing lipid nanoparti
clesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:22Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0852430
Page 147 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crite
rion
Descr
iption
:Investigator site staff o
r Pfizer employees dire
ctly involved in the con
duct of the study, site st
aff otherwise supervise
d by the investigator, a
nd their respective fami
ly members
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX21A01
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852431
Page 148 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.m Exclusion Number:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer
employees directly involved in
the conduct of the study, site st
aff otherwise supervised by the
investigator, and their respectiv
e family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-15-2020 10:18:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0852432
Page 149 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-15-2020 10:18:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-15-2020 10:18:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-15-2020 10:18:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0852433
Page 150 of 215
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-15-2020 10:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-15-2020 10:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
63.8Initial Entry
3. Unit:
Date Location User Value Reason
Sep-15-2020 10:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-15-2020 10:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
170.8Initial Entry
5. Unit:
Date Location User Value Reason
Sep-15-2020 10:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0852434
Page 151 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-15-2020 10:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.9Initial Entry
7.a
Date Location User Value Reason
Sep-15-2020 10:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 36.5
Temperature Unit: C
Temperature Loca
tion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-15-2020 10:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-15-2020 10:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-15-2020 10:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0852435
Page 152 of 215
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-15-2020 10:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0852436
Page 153 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-15-2020 10:26:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2. Randomization Number:
Date Location User ValueReason
Sep-25-2020
09:23:45
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: Clo
sedResponse
satisfies query
Sep-24-2020
10:11:03
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
1: Ans
weredTranscription
Error
Sep-24-2020
10:11:03
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
89392Transcription
Error
Sep-24-2020
04:36:40
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Ope
nedAs per Impala,
Randomization
Number is
89392 . Please
review and
update as
appropriate.
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852437
Page 154 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-15-2020
10:26:33
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
89329Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0852438
Page 155 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020 11:22:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020 11:22:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-15-2020 11:22:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 11:22:27
(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-15-2020 11:22:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852439
Page 156 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-15-2020 11:22:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP7K08Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-15-2020 11:22:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP7K08Initial Entry
5.b
Date Location User Value Reason
Sep-15-2020 11:22:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP7K07Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-15-2020 11:22:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP7K07Initial Entry
5.c
Date Location User Value Reason
Sep-15-2020 11:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP7K06Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852440
Page 157 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.c Sample ID
Date Location User Value Reason
Sep-15-2020 11:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP7K06Initial Entry
5.d
Date Location User Value Reason
Sep-15-2020 11:22:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLBPRMInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-15-2020 11:22:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLBPRMInitial Entry
5.e
Date Location User Value Reason
Sep-15-2020 11:23:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLBPRLInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-15-2020 11:23:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLBPRLInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852441
Page 158 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020 11:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020 11:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-15-2020 11:23:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 11:23:17
(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-15-2020 11:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852442
Page 159 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-15-2020 11:23:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPWV0TInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-15-2020 11:23:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPWV0TInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852443
Page 160 of 215
***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: 12261707 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-15-2020 10:34:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-15-2020 10:34:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-15-2020 10:34:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-15-2020 10:34:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/14/2020 12:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-15-2020 10:34:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0852444
Page 161 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-15-2020 10:34:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-15-2020 10:34:36
(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-15-2020 10:34:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-15-2020 10:34:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0852445
Page 162 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-15-2020 10:34:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0852446
Page 163 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-05-2020 16:01:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852447
Page 164 of 215
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Oct-05-2020 16:02:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
2.a
Date Location User Value Reason
Oct-05-2020 16:02:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 36.5
Temperature Unit
:C
Temperature Loc
ation::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-05-2020 16:02:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-05-2020 16:02:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.5Initial Entry
2.a Unit:
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852448
Page 165 of 215
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Oct-05-2020 16:02:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-05-2020 16:02:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852449
Page 166 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-05-2020 17:32:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-05-2020 17:32:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020 17:32:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-05-2020 17:32:05
(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.
Oct-05-2020 17:32:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852450
Page 167 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-05-2020 17:32:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPVZ02Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-05-2020 17:32:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPVZ02Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852451
Page 168 of 215
***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: 12261707 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
Oct-05-2020 16:03:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-05-2020 16:03:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-05-2020 16:03:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-05-2020 16:03:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/5/2020 12:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-05-2020 16:03:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852452
Page 169 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
6. Body Side:
Date Location User Value Reason
Oct-05-2020 16:03:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-05-2020 16:03:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-05-2020 16:03:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-05-2020 16:03:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852453
Page 170 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020 17:11:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/3/2020Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852454
Page 171 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-03-2020 18:02:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-03-2020 18:02:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-03-2020 18:02:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-03-2020 18:02:19
(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.
Nov-03-2020 18:02:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/3/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852455
Page 172 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-03-2020 18:02:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR78CSInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-03-2020 18:02:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR78CSInitial Entry
5.b
Date Location User Value Reason
Nov-03-2020 18:02:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2VCHInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-03-2020 18:02:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS2VCHInitial Entry
5.c
Date Location User Value Reason
Nov-03-2020 18:02:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2VCJInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852456
Page 173 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.c Sample ID
Date Location User Value Reason
Nov-03-2020 18:02:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS2VCJInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852457
Page 174 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 12261707 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-03-2021 16:45:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Mar-03-2021 15:17:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Mar-03-2021 15:17:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Mar-03-2021 15:17:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/3/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Mar-03-2021 15:17:34 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852458
Page 175 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City of
Buenos Aires(autocalc) COVID_A
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0852459
Page 176 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/3/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/27/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resol
ved:
Feb/28/2021Initial Entry
4.a
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852460
Page 177 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires
4.a Was symptom present?
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCRE
ASED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COU
GHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SHORTNESSInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852461
Page 178 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
OF BREATH
Sympto
m Pres
ent:NO
4.c Symptoms:
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHO
RTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852462
Page 179 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4.d Symptoms:
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE P
AIN
Sympto
m Prese
nt:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUS
CLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852463
Page 180 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4.f
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMEL
L
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE THR
OAT
Sympto
m Prese
nt:NOInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852464
Page 181 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4.g Symptoms:
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SOR
E THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852465
Page 182 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Mar-03-2021 15:18:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852466
Page 183 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Mar-03-2021 15:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Specimen Type:
Date Location User Value Reason
Mar-03-2021 15:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Mar-03-2021 15:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Mar-03-2021 15:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Device Type:
Date Location User Value Reason
Mar-03-2021 15:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Trade Name:
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852467
Page 184 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Mar-03-2021 15:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Test Result:
Date Location User Value Reason
Mar-03-2021 15:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Mar-03-2021 15:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Mar-03-2021 15:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852468
Page 185 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - 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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-03-2021 16:46:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-03-2021 16:46:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-03-2021 16:46:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User ValueReason
Mar-10-2021
12:50:45
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: Clo
sedquery unclear
no data issue
Mar-10-2021
07:25:04
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dPer query
resolution
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852469
Page 186 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - 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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Mar-10-2021
07:25:04
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
Subje
ct ca
me to
site to
the vi
sit, re
corde
d at s
wab p
fePer query
resolution
Mar-10-2021
06:58:09
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedThe following
text was
indicated in the
"Reason
sample was not
collected" field
[collected].
Please review
if sample was
collected if yes
update sample
ID or else
clarify.
Mar-03-2021
16:46:17
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
Sampl
e was
collec
ted on
site, r
ecord
ed at s
wab p
feInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0852470
Page 187 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-03-2021 16:45:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-03-2021 16:45:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-03-2021 16:46:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-03-2021 16:45:54
(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-03-2021 16:45:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/3/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852471
Page 188 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Mar-03-2021 16:46:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR61BFInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-03-2021 16:46:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR61BFInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0852472
Page 189 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitione
r:SPECI
ALIST
Occurrence of Visi
ts or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:EMERGE
NCY ROO
M
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852473
Page 190 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:PRIMARY C
ARE PHYSI
CIAN
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIA
NInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852474
Page 191 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.d
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practition
er:URGEN
T CARE
Occurrence of Vis
its or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pract
itioner:TELEPHON
E CONSULT
ATION
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852475
Page 192 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATI
ONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits
or Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852476
Page 193 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Mar-03-2021 15:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852477
Page 194 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Mar-03-2021 15:21:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLN
ESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Mar-03-2021 15:21:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Mar-03-2021 15:21:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852478
Page 195 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: VITAL SIGNS - COVID - Audit Trail
Form Version: 21-Aug-2020 02:50 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Mar-04-2021 15:50:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852479
Page 196 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: VITAL SIGNS - COVID - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Mar-04-2021 15:50:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/3/2021Initial Entry
2.a
Date Location User Value Reason
Mar-04-2021 15:50:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Systolic:: 12
0
Diastolic:: 80
Respiratory Rate in resp
irations/minute:16
Heart Rate in beats/min
ute:72Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Mar-04-2021 15:50:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Systolic:
Date Location User Value Reason
Mar-04-2021 15:50:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
120Initial Entry
2.a Diastolic:
Date Location User Value Reason
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852480
Page 197 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: VITAL SIGNS - COVID - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Mar-04-2021 15:50:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
80Initial Entry
2.a Respiratory Rate in respirations/minute:
Date Location User Value Reason
Mar-04-2021 15:50:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.a Heart Rate in beats/minute:
Date Location User Value Reason
Mar-04-2021 15:50:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
72Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852481
Page 198 of 215
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Audit Trail
Form Version: 21-Aug-2020 02:51 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Mar-03-2021 15:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852482
Page 199 of 215
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Mar/03/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Mar-03-2021 15:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/3/2021Initial Entry
2.a
Date Location User Value Reason
Mar-03-2021 15:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Oxygen Saturation: 99.0Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Mar-03-2021 15:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a SPO2 Pulse Oximetry %
Date Location User Value Reason
Mar-03-2021 15:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
99.0Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852483
Page 200 of 215
***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: 12261707 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
Nov-03-2020 17:11:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-03-2020 17:11:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-03-2020 17:11:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852484
Page 201 of 215
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 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-01-2021 09:24:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/22/2021Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852485
Page 202 of 215
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 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-01-2021 09:24:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-01-2021 09:24:08
(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-01-2021 09:24:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing to retur
n for Vaccination 3
Participant is:
eligible and NOT confirm
ed to have received only p
lacebo at Vaccination 1/2Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852486
Page 203 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Nov-03-2020 17:13:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852487
Page 204 of 215
***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: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Nov-03-2020 17:14:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852488
Page 205 of 215
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Nov-03-2020 17:13:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-03-2020 17:13:19
(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-03-2020 17:13:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
fever (37,8 C)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-03-2020 17:13:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/5/2020 20:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-03-2020 17:13:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:Initial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852489
Page 206 of 215
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct/5/2020 UNK:UNK
6. Toxicity Grade:
Date Location User Value Reason
Nov-03-2020 17:13:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-03-2020 17:13:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-03-2020 17:13:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-03-2020 17:13:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852490
Page 207 of 215
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-03-2020 17:13:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-03-2020 17:13:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-03-2020 17:13:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-03-2020 17:13:19
(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
Nov-03-2020 17:13:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0852491
Page 208 of 215
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Nov-03-2020 17:14:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-03-2020 17:14:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-16-2020 09:12:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
axillary lymphadenopathy i
n the left armNew Information
Nov-04-2020 13:26:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-04-2020 13:23:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-04-2020 13:23:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
axillary lymphadenopathyTranscription Error
Nov-04-2020 09:42:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened GPD Clinical:
please clarify the
location of the
Lymphadenopathy,
thank you.
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0852492
Page 209 of 215
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-03-2020 17:14:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
lymphadenopathyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-16-2020 11:10:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-16-2020 09:12:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Data updated.
Nov-14-2020 00:08:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Could you please
explain if the AE
did not exist at
all? Otherwise
report if at left,
right or both sites
Nov-13-2020 17:09:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Candidate Could you please
explain if the AE
did not exist at
all? Otherwise
report if at left,
right or both sites
Nov-03-2020 17:14:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/6/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-03-2020 17:14:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/8/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae406c\Final\Final On: 01-Apr-2021 05:39 (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) (6)
(b) (4)
FDA-CBER-2021-5683-0852493
Page 210 of 215
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261707 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Nov-03-2020 17:14:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacit
…[truncated]