125742 S1 M5 CRF c4591001 1226 12261769

Document text

Page 1 of 222
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
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: 12261769 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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853064
Page 2 of 222
***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: 12261769 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/17/2020
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853065
Page 3 of 222
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12261769]
2.Birth Date: 1970
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0853066
Page 4 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853067
Page 5 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study
stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits, vaccination plan,
laboratory tests, lifestyle considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use only) IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active suicidal
ideation/behavior/lab abnormality that may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853068
Page 6 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction
(eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853069
Page 7 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 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
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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853070
Page 8 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853071
Page 9 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Fibromyalgia]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Hysterectomy]
Start Date: Feb/UNK/2019
Ongoing: NO
End Date:
Feb/UNK/2019
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Perforation of the uterus by IUD]
Start Date: Feb/UNK/2019
Ongoing: NO
End Date:
Feb/UNK/2019
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Obesity]
Start Date: Mar/UNK/2019
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[low back pain]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853072
Page 10 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
2.Weight: [83.3]
3.Unit: kg
4.Height: [150.3]
5.Unit: cm
6.Body Mass Index: [36.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853073
Page 11 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/17/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853074
Page 12 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/17/2020
2.Randomization Number: [91945]
3.Randomization Group: [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853075
Page 13 of 222
***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: 12261769 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/17/2020
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 [BP7K7W]
5.bSample ID [BP7K7V]
5.cSample ID [BP7K7T]
5.dSample ID [BRXVVP]
5.eSample ID [BRXVVR]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853076
Page 14 of 222
***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: 12261769 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/17/2020
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 [BP7WS0]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853077
Page 15 of 222
***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: 12261769 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/17/2020 10:04
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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853078
Page 16 of 222
***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: 12261769 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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853079
Page 17 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853080
Page 18 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Oct/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853081
Page 19 of 222
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/7/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853082
Page 20 of 222
***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: 12261769 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/7/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWZ44]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853083
Page 21 of 222
***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: 12261769 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/7/2020 10:12
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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853084
Page 22 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853085
Page 23 of 222
***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: 12261769 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:
Dec/17/2020
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 [BRGTKK]
5.bSample ID [BSF241]
5.cSample ID [BSF249]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853086
Page 24 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853087
Page 25 of 222
***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: 12261769 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 [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853088
Page 26 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853089
Page 27 of 222
***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: 12261769 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 [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853090
Page 28 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853091
Page 29 of 222
***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: 12261769 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 [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853092
Page 30 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/18/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853093
Page 31 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Mar/18/2021
2.Date of First Symptom Started: Mar/15/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
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? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
5.aSymptoms - Other Text: [headache]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853094
Page 32 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locatio
nAssay Code and Descriptio
nDevice Type Form Instance
 1.Not Applicable  Not Applicable
 Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853095
Page 33 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853096
Page 34 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 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:[collected on site]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853097
Page 35 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 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/18/2021
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 [BRGZ8Y]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853098
Page 36 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 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: [ ]
Health Care Utilization
3.Has the subject been hospitalized due to
potential COVID-19 illness?NO
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853099
Page 37 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853100
Page 38 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 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?
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853101
Page 39 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853102
Page 40 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853103
Page 41 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 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:
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853104
Page 42 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for Lab T
estVendor Na
meCollection Dat
e:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Identif
ierTest
:Result
:Repeating
Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853105
Page 43 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853106
Page 44 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for Lab
TestVendor Name (DERI
VED)Collection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853107
Page 45 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-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: 12261769 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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853108
Page 46 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Mar/18/2021 Record Identifier: Systolic: Diastolic:
1  124  89 Repeating Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853109
Page 47 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-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: 12261769 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/18/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [124]
Diastolic: [89]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [98]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853110
Page 48 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Mar/18/2021 Record Identifier: Oxygen Saturation
1  98.0 Repeating Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853111
Page 49 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 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/18/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853112
Page 50 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853113
Page 51 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 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): [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853114
Page 52 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Iden
tifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853115
Page 53 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 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?
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853116
Page 54 of 222
***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: 12261769 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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853117
Page 55 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 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:
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853118
Page 56 of 222
***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: 12261769 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:
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853119
Page 57 of 222
***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: 12261769 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 [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853120
Page 58 of 222
***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: 12261769 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:
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853121
Page 59 of 222
***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: 12261769 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 [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853122
Page 60 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853123
Page 61 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853124
Page 62 of 222
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/17/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853125
Page 63 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853126
Page 64 of 222
***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: 12261769 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:
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853127
Page 65 of 222
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853128
Page 66 of 222
***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: 12261769 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?
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853129
Page 67 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853130
Page 68 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853131
Page 69 of 222
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853132
Page 70 of 222
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853133
Page 71 of 222
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 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 [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853134
Page 72 of 222
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 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 [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853135
Page 73 of 222
***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: 12261769 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: [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853136
Page 74 of 222
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853137
Page 75 of 222
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853138
Page 76 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EVE
NT 1  Pruridus at the injection site  Sep/17/2020 18:15  NO
End Date Time:
Sep/20/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EVE
NT 2  idiopathic intracranial hypert
ension Oct/22/2020 UNK:
UNK NO
End Date Time:
Oct/30/2020 UNK:UNK
 Repeating
Pages
 3.ADVERSE EVE
NT 3  surgical site infection (Flank)
 Nov/3/2020 UNK:U
NK NO
End Date Time:
Dec/11/2020 UNK:UNK
 Repeating
Pages
 4.ADVERSE EVE
NT 4  Muscle pain  Oct/7/2020 12:00  NO
End Date Time:
Oct/9/2020 UNK:UNK
 Repeating
Pages
 5.ADVERSE EVE
NT 5  Fever 38.2 C  Oct/7/2020 14:00  NO
End Date Time:
Oct/9/2020 UNK:UNK
 Repeating
Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853139
Page 77 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 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)[Pruridus at the injection site]
4.Start Date Time: Sep/17/2020 18:15
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/20/2020 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
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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853140
Page 78 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853141
Page 79 of 222
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 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)[idiopathic intracranial hypertension]
4.Start Date Time: Oct/22/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/30/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[idiopathic]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853142
Page 80 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020429354]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853143
Page 81 of 222
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[surgical site infection (Flank)]
4.Start Date Time: Nov/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/11/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[peritoneal loin shunt]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853144
Page 82 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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[2020431466]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853145
Page 83 of 222
***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: 12261769 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Muscle pain]
4.Start Date Time: Oct/7/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/9/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? 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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853146
Page 84 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853147
Page 85 of 222
***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: 12261769 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: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fever 38.2 C]
4.Start Date Time: Oct/7/2020 14:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/9/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? 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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853148
Page 86 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853149
Page 87 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Acti
onForm Instance
 1.          Repeating Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853150
Page 88 of 222
***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: 12261769 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[ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853151
Page 89 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Iden
tifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853152
Page 90 of 222
***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: 12261769 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: //
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853153
Page 91 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionDose Descrip
tionForm Instance
 1.          Repeating
Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853154
Page 92 of 222
***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: 12261769 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?
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853155
Page 93 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853156
Page 94 of 222
***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: 12261769 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?
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853157
Page 95 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
 1.     Repeating Pages
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853158
Page 96 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853159
Page 97 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853160
Page 98 of 222
***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: 12261769 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?
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853161
Page 99 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/6/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853162
Page 100 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853163
Page 101 of 222
***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: 12261769 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: [ ]
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853164
Page 102 of 222
***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: 12261769 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 Dec/17/2020
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853165
Page 103 of 222
***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: 12261769 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
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853166
Page 104 of 222
***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: 12261769 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-19-2021 15:51:23 (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.
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853167
Page 105 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormMar-19-2021 09:45:57 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0853168
Page 106 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Mar-19-2021 09:45:57 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853169
Page 107 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Mar-19-2021 09:45:57 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0853170
Page 108 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Mar-19-2021 09:45:57 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853171
Page 109 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Mar-19-2021 09:45:57 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853172
Page 110 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Mar-19-2021 09:45:57 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853173
Page 111 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Mar-19-2021 09:45:57 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0853174
Page 112 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
7Mar-19-2021 09:45:57 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0853175
Page 113 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
8Mar-19-2021 09:45:57 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0853176
Page 114 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
9Mar-19-2021 09:45:57 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853177
Page 115 of 222
***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: 12261769 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-19-2021 15:51:23 (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-19-2021 09:36:49 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Feb-12-2021 10:22:08 (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-10-2021 15:10:43 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Jan-21-2021 17:36:43 (UTC-03:00) City of Buenos
AiresBOOK Signed
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0853178
Page 116 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-01-2020 16:47:08 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Nov-30-2020 15:36:50 (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-19-2020 16:34:17 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Nov-11-2020 21:59:39 (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.
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0853179
Page 117 of 222
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - 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: 12261769 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-17-2020 14:42:04
(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-17-2020 14:42:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853180
Page 118 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-17-2020 14:42:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/17/2020Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853181
Page 119 of 222
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-17-2020 14:41:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12261769Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-17-2020 14:41:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1970Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-17-2020 14:42:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-17-2020 14:42:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF SPA
NISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-17-2020 14:42:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853182
Page 120 of 222
***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: 12261769 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-17-2020 14:43:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853183
Page 121 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n: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)
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Male or female participants between the a
ges of 18 and 55 years, inclusive, 65 and
85 years, inclusive, or 18 and 85 years, in
clusive, at randomization (dependent upo
n study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853184
Page 122 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusio
n Numb
er:2
Criterio
n Descr
iption:Participants who are willing an
d able to comply with all sched
uled visits, vaccination plan, la
boratory tests, lifestyle conside
rations, and other study proced
ures
Criterio
n met?:YES
Criterio
n ID: (F
or Pfize
r use on
ly):IN02A00Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853185
Page 123 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Inclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participants who are willing and able to c
omply with all scheduled visits, vaccinati
on plan, laboratory tests, lifestyle conside
rations, and other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusio
n Num
ber:3
Criterio
n Descr
iption:Healthy participants who are d
etermined by medical history, p
hysical examination, and clinic
al judgment of the investigator
to be eligible for inclusion in th
e study
Criterio
n met?:YESInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853186
Page 124 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterio
n ID: (F
or Pfize
r use on
ly):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Healthy participants who are determined
by medical history, physical examination,
and clinical judgment of the investigator t
o be eligible for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusio
n Numb
er:4Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853187
Page 125 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterio
n Descri
ption:Capable of giving personal sig
ned informed consent, which i
ncludes compliance with the re
quirements and restrictions list
ed in the ICD and in this proto
col
Criterio
n met?:YES
Criterio
n ID: (F
or Pfize
r use on
ly):IN04A00
1.d Inclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Capable of giving personal signed inform
ed consent, which includes compliance w
ith the requirements and restrictions liste
d in the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020 14:43:38 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853188
Page 126 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City of Buenos
AiresExclusi
on Nu
mber:1
Criteri
on Desc
ription:Other medical or psychiatric co
ndition incl. recent (within past
year) or active suicidal ideation
/behavior/lab abnormality that
may increase the risk of study p
articipation
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Other medical or psychiatric condition in
cl. recent (within past year) or active suic
idal ideation/behavior/lab abnormality th
at may increase the risk of study participa
tionInitial Entry
2.a Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853189
Page 127 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.b
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:2
Criterion
Descripti
on:Known infection with human
immunodeficiency virus (HI
V), hepatitis C virus (HCV),
or hepatitis B virus (HBV)
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX02A00Initial Entry
2.b Exclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Known infection with human immunodef
iciency virus (HIV), hepatitis C virus (H
CV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853190
Page 128 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:3
Criterio
n Descri
ption:History of severe adverse react
ion associated with a vaccine a
nd/or severe allergic reaction (
eg, anaphylaxis) to any compo
nent of the study intervention(s
)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX03A00Initial Entry
2.c Exclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
History of severe adverse reaction associ
ated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any compon
ent of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853191
Page 129 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.d
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion Num
ber:4
Criterion Desc
ription:Receipt of medications
intended to prevent CO
VID-19
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX04A00Initial Entry
2.d Exclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Receipt of medications intended to preve
nt COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Sep-17-2020 14:43:38 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853192
Page 130 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City of Buenos
AiresExclusio
n Numb
er:8
Criterio
n Descri
ption:Immunocompromised individu
als with known or suspected i
mmunodeficiency, as determin
ed by history and/or laboratory
/physical examination
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Immunocompromised individuals with k
nown or suspected immunodeficiency, as
determined by history and/or laboratory/p
hysical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853193
Page 131 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:10
Criterio
n Descri
ption:Bleeding diathesis or condition
associated with prolonged blee
ding that would, in the opinion
of the investigator, contraindic
ate intramuscular injection
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX10A00Initial Entry
2.f Exclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition associate
d with prolonged bleeding that would, in
the opinion of the investigator, contraindi
cate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853194
Page 132 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion Numbe
r:11
Criterion Descrip
tion:Women who are preg
nant or breastfeeding
Criterion met?: NO
Criterion ID: (Fo
r Pfizer use only)
:EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Women who are pregnant or breastfeedin
gInitial Entry
2.g Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion Num
ber:12Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853195
Page 133 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterion Descr
iption:Previous vaccination
with any coronavirus v
accine
Criterion met?: NO
Criterion ID: (F
or Pfizer use on
ly):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Previous vaccination with any coronaviru
s vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:13
Criterion
Descriptio
n:Subjects who receive immu
nosuppressive therapy, such
as cytotoxic agents or syste
mic corticosteroidsInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853196
Page 134 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterion
met?:NO
Criterion
ID: (For P
fizer use o
nly):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Subjects who receive immunosuppressive
therapy, such as cytotoxic agents or syste
mic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:15
Criterio
n Descri
ption:Receipt of blood/plasma produ
cts or immunoglobulin, from 6
0 days before study interventio
n administration or planned rec
eipt throughout the studyInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853197
Page 135 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX14A01
2.j Exclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products or imm
unoglobulin, from 60 days before study i
ntervention administration or planned rec
eipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853198
Page 136 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
2.k
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numbe
r:16
Criterion
Descripti
on:Participation in other studies
involving study intervention
within 28 days prior to study
entry and/or during study part
icipation
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX15A01Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853199
Page 137 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.k Exclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participation in other studies involving st
udy intervention within 28 days prior to s
tudy entry and/or during study participati
onInitial Entry
2.k Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in ot
her studies involving study
intervention containing lipi
d nanoparticles
Criterion
met?:NO
Criterion I
D: (For Pfi
zer use onl
y):EX16A01Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853200
Page 138 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.l Exclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Previous participation in other studies in
volving study intervention containing lipi
d nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:22
Criteri
on Des
criptio
n: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 members
Criteri
on met
?:NOInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853201
Page 139 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on ID:
(For Pf
izer use
only):EX21A01
2.m Exclusion Number:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Sep-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer employee
s directly involved in the conduct of the s
tudy, site staff otherwise supervised by th
e investigator, and their respective family
membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Sep-17-2020 14:43:38
(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-17-2020 14:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853202
Page 140 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 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-17-2020 14:44:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-17-2020 14:44:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-17-2020 14:44:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853203
Page 141 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Sep-17-2020 14:45:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term
:Fibromyalgia
Start Date: UNK/UNK/201
5
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-17-2020 14:45:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 14:45:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
FibromyalgiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-17-2020 14:45:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-17-2020 14:45:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-17-2020 14:46:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853204
Page 142 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Medical History Ter
m:Hysterectomy
Start Date: Feb/UNK/2019
Ongoing: NO
End Date:
Feb/UNK/201
9
1.b Line/MH Number:
Date Location User Value Reason
Sep-17-2020 14:46:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 14:46:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
HysterectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-17-2020 14:46:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Feb/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-17-2020 14:46:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Feb/UNK/2019Initial Entry
1.c
Date Location User Value Reason
Sep-17-2020 14:48:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical Histor
y Term:Perforation of the uteru
s by IUDInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853205
Page 143 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Start Date: Feb/UNK/2019
Ongoing: NO
End Date:
Feb/UNK/2019
1.c Line/MH Number:
Date Location User Value Reason
Sep-17-2020 14:48:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 14:48:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Perforation of the uterus by IUDInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-17-2020 14:48:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Feb/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-17-2020 14:48:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Feb/UNK/2019Initial Entry
1.d
Date Location User Value Reason
Sep-17-2020 14:49:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Term: Obesity
Start Date: Mar/UNK/2019
Ongoing: YESInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853206
Page 144 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.d Line/MH Number:
Date Location User Value Reason
Sep-17-2020 14:49:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 14:49:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
ObesityInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-17-2020 14:49:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Mar/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-17-2020 14:49:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Nov-05-2020 11:26:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Term
:low back pain
Start Date: UNK/UNK/201
8
Ongoing: YESInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853207
Page 145 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.e Line/MH Number:
Date Location User Value Reason
Nov-05-2020 11:26:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-05-2020 11:26:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
low back painInitial Entry
1.e Start Date:
Date Location User Value Reason
Nov-05-2020 11:26:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Nov-05-2020 11:26:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853208
Page 146 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020 14:49:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-17-2020 14:49:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
83.3Initial Entry
3. Unit:
Date Location User Value Reason
Sep-17-2020 14:49:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-17-2020 14:49:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
150.3Initial Entry
5. Unit:
Date Location User Value Reason
Sep-17-2020 14:49:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-17-2020 14:49:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
36.9Initial Entry
7.a
Date Location User Value Reason
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853209
Page 147 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-17-2020 14:49:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Location:: FOREHEADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-17-2020 14:49:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-17-2020 14:49:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-17-2020 14:49:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-17-2020 14:49:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853210
Page 148 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-17-2020 14:52:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-17-2020 14:52:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-17-2020 14:52:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-17-2020 14:52:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-17-2020 14:52:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-17-2020 14:52:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853211
Page 149 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
6.a Sponsor ID:
Date Location User Value Reason
Sep-17-2020 14:52:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-17-2020 14:52:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-17-2020 14:52:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853212
Page 150 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-17-2020 14:52:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-17-2020 14:52:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
91945Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853213
Page 151 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 11:32:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 11:32:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 11:32:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 11:32:47
(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-18-2020 11:32:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020 11:32:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP7K7WInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020 11:32:54
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry:
BP7K7WInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853214
Page 152 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aires
5.b
Date Location User Value Reason
Sep-18-2020 11:33:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP7K7VInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-18-2020 11:33:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP7K7VInitial Entry
5.c
Date Location User Value Reason
Sep-18-2020 11:33:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP7K7TInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-18-2020 11:33:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP7K7TInitial Entry
5.d
Date Location User Value Reason
Sep-18-2020 11:33:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRXVVPInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853215
Page 153 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.d Sample ID
Date Location User Value Reason
Sep-18-2020 11:33:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BRXVVPInitial Entry
5.e
Date Location User Value Reason
Sep-18-2020 11:33:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRXVVRInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-18-2020 11:33:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BRXVVRInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853216
Page 154 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 11:33:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 11:33:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 11:33:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 11:33:51
(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-18-2020 11:33:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020 11:33:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP7WS0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020 11:33:58
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry:
BP7WS0Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853217
Page 155 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aires
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853218
Page 156 of 222
***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: 12261769 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-17-2020 14:53:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020 14:53:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020 14:53:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-17-2020 14:53:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020 10:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020 14:53:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-17-2020 14:53:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853219
Page 157 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-17-2020 14:53:14
(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-17-2020 14:53:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION 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-17-2020 14:53:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853220
Page 158 of 222
***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: 12261769 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-17-2020 14:53:25
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY N
OT COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853221
Page 159 of 222
***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: 12261769 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-07-2020 13:07:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853222
Page 160 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Oct-07-2020 13:07:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2.a
Date Location User Value Reason
Oct-07-2020 13:07:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.4
Temperature Unit: C
Temperature Location:: FOREHEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-07-2020 13:07:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-07-2020 13:07:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-07-2020 13:07:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-07-2020 13:07:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853223
Page 161 of 222
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-07-2020 13:07:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-07-2020 13:07:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-07-2020 13:07:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-07-2020 13:07:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-07-2020 13:07:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-07-2020 13:07:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853224
Page 162 of 222
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
6.a Sponsor ID:
Date Location User Value Reason
Oct-07-2020 13:07:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-07-2020 13:07:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-07-2020 13:07:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0853225
Page 163 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020 09:46:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020 09:46:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020 09:46:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-08-2020 09:46:40
(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-08-2020 09:46:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-08-2020 09:46:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPWZ44Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-08-2020 09:46:56
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry:
BPWZ44Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853226
Page 164 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aires
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853227
Page 165 of 222
***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: 12261769 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-07-2020 13:08:19
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-07-2020 13:08:19
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-07-2020 13:08:19
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-07-2020 13:08:19
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/7/2020 10:12Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-07-2020 13:08:19
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-07-2020 13:08:19
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853228
Page 166 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-07-2020 13:08:19
(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-07-2020 13:08:19
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION 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-07-2020 13:08:19
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0853229
Page 167 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-21-2020
05:38:06
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1:
ClosedClosed per SITE response,
added to PD tracker for
Clinical Review
Dec-18-2020
08:47:52
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1:
Answere
dOriginal value is correct
Dec-18-2020
08:01:51
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1:
OpenedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 36 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately. 
Dec-17-2020
16:18:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Ent
ry:
Dec/17/2
020Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0853230
Page 168 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 08:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 08:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020 08:46:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 08:46:46
(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.
Dec-18-2020 08:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/17/2020Initial Entry
5.a
Date Location User Value Reason
Dec-18-2020 08:46:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRGTKKInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-18-2020 08:46:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BRGTKKInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853231
Page 169 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.b
Date Location User Value Reason
Dec-18-2020 08:47:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BSF241Transcription Error
Dec-18-2020 08:47:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRGTKKInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-18-2020 08:47:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BSF241Transcription Error
Dec-18-2020 08:47:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BRGTKKInitial Entry
5.c
Date Location User Value Reason
Dec-18-2020 08:47:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BSF249Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-18-2020 08:47:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BSF249Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853232
Page 170 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 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-19-2021 09:44:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Mar-19-2021 09:36:46
(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-19-2021 09:36:46
(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-19-2021 09:36:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Mar/18/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Mar-19-2021 09:36:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853233
Page 171 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 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-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Mar/18/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Mar/15/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853234
Page 172 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
COUGH
Symptom Pre
sent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCREASED SH
ORTNESS OF BREATH
Symptom
Present:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTNESS O
F BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853235
Page 173 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAIN
Symptom P
resent:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853236
Page 174 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: NEW LOSS OF TASTE
OR SMELL
Symptom Pr
esent:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED S
ORE THROAT
Symptom P
resent:YESInitial Entry
4.g Symptoms:
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE THROA
TInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (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-2021-5683-0853237
Page 175 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: YESInitial Entry
4.i Symptoms:
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Mar-19-2021 09:40:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
5.a
Date Location User Value Reason
Mar-19-2021 09:41:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms - Other: headacheInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853238
Page 176 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a Symptoms - Other Text:
Date Location User Value Reason
Mar-19-2021 09:41:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
headacheInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0853239
Page 177 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 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-19-2021 09:45:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Specimen Type:
Date Location User Value Reason
Mar-19-2021 09:45:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Mar-19-2021 09:45:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Mar-19-2021 09:45:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Device Type:
Date Location User Value Reason
Mar-19-2021 09:45:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Trade Name:
Date Location User Value Reason
Mar-19-2021 09:45:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Test Result:
Date Location User Value Reason
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853240
Page 178 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Mar-19-2021 09:45:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Mar-19-2021 09:45:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Mar-19-2021 09:45:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853241
Page 179 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-19-2021 09:45:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-19-2021 09:45:21
(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-19-2021 09:45:21
(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 Value Reason
Mar-19-2021 09:45:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
collected on siteInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853242
Page 180 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-19-2021 09:44:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-19-2021 09:44:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-19-2021 09:44:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-19-2021 09:44:24
(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-19-2021 09:44:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/18/2021Initial Entry
5.a
Date Location User Value Reason
Mar-19-2021 09:44:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRGZ8YInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-19-2021 09:44:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BRGZ8YInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853243
Page 181 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIALI
ST
Occurrence of Visits or Co
ntacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: EMERGENCY
ROOM
Occurrence of Visits o
r Contacts:NOInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853244
Page 182 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Mar-19-2021 09:43:38
(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-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Type of Practitione
r:PRIMARY CARE
PHYSICIAN
Occurrence of Visit
s or Contacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: URGENT C
ARE
Occurrence of Visits or
Contacts:NOInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853245
Page 183 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Mar-19-2021 09:43:38
(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-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Type of Practitione
r:TELEPHONE CO
NSULTATION
Occurrence of Visi
ts or Contacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or Conta
cts:NOInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853246
Page 184 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Mar-19-2021 09:43:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853247
Page 185 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: 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: 12261769 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-19-2021 09:43:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Mar-19-2021 09:43:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Mar-19-2021 09:43:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0853248
Page 186 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: VITAL SIGNS - COVID - Audit Trail
Form Version: 15-Sep-2020 21:52 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Mar-19-2021 09:42:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853249
Page 187 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: VITAL SIGNS - COVID - eCRF Audit Trail History
Form Version: 15-Sep-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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Mar-19-2021 09:42:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Mar/18/2021Initial Entry
2.a
Date Location User Value Reason
Mar-19-2021 09:42:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Systolic:: 12
4
Diastolic:: 89
Respiratory Rate in respirations/
minute:16
Heart Rate in beats/minute: 98Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Mar-19-2021 09:42:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Systolic:
Date Location User Value Reason
Mar-19-2021 09:42:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
124Initial Entry
2.a Diastolic:
Date Location User Value Reason
Mar-19-2021 09:42:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
89Initial Entry
2.a Respiratory Rate in respirations/minute:
Date Location User Value Reason
Mar-19-2021 09:42:16
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry:
16Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853250
Page 188 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: VITAL SIGNS - COVID - eCRF Audit Trail History
Form Version: 15-Sep-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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aires
2.a Heart Rate in beats/minute:
Date Location User Value Reason
Mar-19-2021 09:42:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
98Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853251
Page 189 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Audit Trail
Form Version: 15-Sep-2020 21:54 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Mar-19-2021 09:42:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853252
Page 190 of 222
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/18/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Mar-19-2021 09:42:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Mar/18/2021Initial Entry
2.a
Date Location User Value Reason
Mar-19-2021 09:42:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Oxygen Saturation: 98.0Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Mar-19-2021 09:42:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a SPO2 Pulse Oximetry %
Date Location User Value Reason
Mar-19-2021 09:42:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
98.0Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853253
Page 191 of 222
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 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: 12261769 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
Dec-17-2020 16:18:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-17-2020 16:18:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-17-2020 16:18:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0853254
Page 192 of 222
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 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-10-2021 15:10:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Feb/5/2021Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853255
Page 193 of 222
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261769 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-10-2021 15:11:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-10-2021 15:10:53
(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-10-2021 15:10:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participant is willing to return for Vacci
nation 3
Participant is:
eligible and NOT confirmed to have
received only placebo at Vaccinatio
n 1/2Initial Entry
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0853256
Page 194 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Oct-07-2020 13:10:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853257
Page 195 of 222
***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: 12261769 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Nov-04-2020 17:44:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae405c\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853258
Page 196 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVER
…[truncated]