Document text
Page 1 of 185
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 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
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851044
Page 2 of 185
***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: 12261571 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/5/2020
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851045
Page 3 of 185
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12261571]
2.Birth Date: 1975
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851046
Page 4 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/5/2020
2.Erroneous Visit
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851047
Page 5 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 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
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851048
Page 6 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 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
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851049
Page 7 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or systemic
corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to study
entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing lipid
nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
2 mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the study,
site staff otherwise supervised by the investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851050
Page 8 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851051
Page 9 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851052
Page 10 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/5/2020
2.Weight: [68.8]
3.Unit: kg
4.Height: [169.0]
5.Unit: cm
6.Body Mass Index: [24.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851053
Page 11 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/5/2020
2.Randomization Number: [82803]
3.Randomization Group: [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851054
Page 12 of 185
***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: 12261571 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/5/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTJPM]
5.bSample ID [BPTJPN]
5.cSample ID [BPTJPP]
5.dSample ID [BPHNWK]
5.eSample ID [BPHNWL]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851055
Page 13 of 185
***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: 12261571 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/5/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTJP6]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851056
Page 14 of 185
***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: 12261571 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/5/2020 15:08
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
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851057
Page 15 of 185
***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: 12261571 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
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851058
Page 16 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851059
Page 17 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851060
Page 18 of 185
***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: 12261571 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/25/2020
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 [BP7X9X]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851061
Page 19 of 185
***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: 12261571 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/25/2020 09:15
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
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851062
Page 20 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/26/2020
2.Erroneous Visit
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851063
Page 21 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/26/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR60GD]
5.bSample ID [BS2Y0N]
5.cSample ID [BS2Y0P]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851064
Page 22 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851065
Page 23 of 185
***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: 12261571 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 [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851066
Page 24 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851067
Page 25 of 185
***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: 12261571 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 [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851068
Page 26 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851069
Page 27 of 185
***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: 12261571 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 [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851070
Page 28 of 185
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 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:
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851071
Page 29 of 185
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851072
Page 30 of 185
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 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 [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851073
Page 31 of 185
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 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 [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851074
Page 32 of 185
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851075
Page 33 of 185
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851076
Page 34 of 185
***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: 12261571 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:
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851077
Page 35 of 185
***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: 12261571 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 [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851078
Page 36 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851079
Page 37 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851080
Page 38 of 185
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/26/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851081
Page 39 of 185
***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: 12261571 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: [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851082
Page 40 of 185
***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: 12261571 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:
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851083
Page 41 of 185
***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: 12261571 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 [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851084
Page 42 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851085
Page 43 of 185
***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: 12261571 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:
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851086
Page 44 of 185
***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: 12261571 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?
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851087
Page 45 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851088
Page 46 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851089
Page 47 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851090
Page 48 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851091
Page 49 of 185
***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: 12261571 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 [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851092
Page 50 of 185
***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: 12261571 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 [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851093
Page 51 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851094
Page 52 of 185
***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: 12261571 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
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851095
Page 53 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Excoriations in various regions
of the body Oct/21/2020 UNK
:UNK NO
End Date Time:
Oct/30/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Bruises in various regions of th
e body Oct/21/2020 UNK
:UNK NO
End Date Time:
Oct/30/2020 UNK:UNK
Repeating
Pages
3.ADVERSE EV
ENT 3 Peri-renal hematoma Oct/21/2020 UNK
:UNK NO
End Date Time:
Oct/30/2020 UNK:UNK
Repeating
Pages
4.ADVERSE EV
ENT 4 Subarachnoid hemorrhage Oct/21/2020 UNK
:UNK NO
End Date Time:
Oct/30/2020 UNK:UNK
Repeating
Pages
5.ADVERSE EV
ENT 5 Fracture of the fourth cervical v
ertebra Oct/21/2020 UNK
:UNK NO
End Date Time:
Oct/30/2020 UNK:UNK
Repeating
Pages
6.ADVERSE EV
ENT 6 Cervical spinal cord contusion Oct/21/2020 UNK
:UNK NO
End Date Time:
Oct/30/2020 UNK:UNK
Repeating
Pages
7.ADVERSE EV
ENT 7 hit by motorcycle Oct/21/2020 18:0
0 NO
End Date Time:
Oct/21/2020 UNK:UNK
Repeating
Pages
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851096
Page 54 of 185
***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: 12261571 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)[Excoriations in various regions of the body]
4.Start Date Time: Oct/21/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/30/2020 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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[hit by motorcycle]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851097
Page 55 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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[ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851098
Page 56 of 185
***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: 12261571 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)[Bruises in various regions of the body]
4.Start Date Time: Oct/21/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/30/2020 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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[hit by motorcycle]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851099
Page 57 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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[ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851100
Page 58 of 185
***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: 12261571 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)[Peri-renal hematoma]
4.Start Date Time: Oct/21/2020 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
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[hit by motorcycle]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851101
Page 59 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020418631]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851102
Page 60 of 185
***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: 12261571 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)[Subarachnoid hemorrhage]
4.Start Date Time: Oct/21/2020 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
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[hit by motorcycle]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851103
Page 61 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020418631]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851104
Page 62 of 185
***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: 12261571 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)[Fracture of the fourth cervical vertebra]
4.Start Date Time: Oct/21/2020 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
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[hit by motorcycle]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851105
Page 63 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020418631]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851106
Page 64 of 185
***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: 12261571 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: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Cervical spinal cord contusion]
4.Start Date Time: Oct/21/2020 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
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[hit by motorcycle]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851107
Page 65 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020418631]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851108
Page 66 of 185
***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: 12261571 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: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[hit by motorcycle]
4.Start Date Time: Oct/21/2020 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/21/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[accidental]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851109
Page 67 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? 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[2020418631]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851110
Page 68 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851111
Page 69 of 185
***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: 12261571 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[ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851112
Page 70 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851113
Page 71 of 185
***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: 12261571 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: //
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851114
Page 72 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851115
Page 73 of 185
***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: 12261571 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?
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851116
Page 74 of 185
***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: 12261571 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
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851117
Page 75 of 185
***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: 12261571 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?
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851118
Page 76 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851119
Page 77 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851120
Page 78 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851121
Page 79 of 185
***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: 12261571 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?
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851122
Page 80 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/10/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851123
Page 81 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851124
Page 82 of 185
***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: 12261571 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: [ ]
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851125
Page 83 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/26/2020
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851126
Page 84 of 185
***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: 12261571 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
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851127
Page 85 of 185
***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: 12261571 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 Feb-12-2021 10:00:15 (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.
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851128
Page 86 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-05-2020 16:40:27 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851129
Page 87 of 185
***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: 12261571 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 Feb-12-2021 10:00:15 (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-11-2021 17:43:59 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini Approved Nov-30-2020 15:32:04 (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-26-2020 16:51:45 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini Approved Nov-26-2020 16:24:02 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851130
Page 88 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-26-2020 12:15:10 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini Approved Nov-06-2020 15:37:22 (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.
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851131
Page 89 of 185
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 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-05-2020 16:36:03
(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-05-2020 16:36:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851132
Page 90 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-05-2020 16:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/5/2020Initial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851133
Page 91 of 185
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-05-2020 16:35:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12261571Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-05-2020 16:35:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1975Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-05-2020 16:36:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-05-2020 16:36:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-05-2020 16:36:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851134
Page 92 of 185
***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: 12261571 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-05-2020 16:36:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/5/2020Initial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851135
Page 93 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants b
etween the ages of 18 and 55
years, inclusive, 65 and 85 ye
ars, inclusive, or 18 and 85 y
ears, inclusive, at randomizat
ion (dependent upon study st
age)
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Male or female participants between t
he ages of 18 and 55 years, inclusive,
65 and 85 years, inclusive, or 18 and 8
5 years, inclusive, at randomization (d
ependent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851136
Page 94 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willing
and able to comply with all s
cheduled visits, vaccination
plan, laboratory tests, lifesty
le considerations, and other
study procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN02A00Initial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851137
Page 95 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Inclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are willing and able t
o comply with all scheduled visits, vac
cination plan, laboratory tests, lifestyl
e considerations, and other study proc
eduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae4057\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-2021-5683-0851138
Page 96 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on Des
criptio
n:Healthy participants who are
determined by medical histo
ry, physical examination, an
d clinical judgment of the in
vestigator to be eligible for i
nclusion in the study
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only):IN03A00
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851139
Page 97 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.c Inclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants who are determin
ed by medical history, physical exami
nation, and clinical judgment of the in
vestigator to be eligible for inclusion i
n the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae4057\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-2021-5683-0851140
Page 98 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on Desc
ription:Capable of giving personal s
igned informed consent, whi
ch includes compliance with
the requirements and restrict
ions listed in the ICD and in
this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN04A00
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851141
Page 99 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.d Inclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal signed info
rmed consent, which includes complia
nce with the requirements and restricti
ons listed in the ICD and in this protoc
olInitial Entry
1.d Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:1Initial Entry
090177e196ae4057\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-2021-5683-0851142
Page 100 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on Des
criptio
n:Other medical or psychiatric
condition incl. recent (within
past year) or active suicidal i
deation/behavior/lab abnorm
ality that may increase the ris
k of study participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatric condition
incl. recent (within past year) or active
suicidal ideation/behavior/lab abnorm
ality that may increase the risk of stud
y participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
090177e196ae4057\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)
FDA-CBER-2021-5683-0851143
Page 101 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires
2.b
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:2
Criterion
Descripti
on:Known infection with hum
an immunodeficiency viru
s (HIV), hepatitis C virus (
HCV), or hepatitis B virus
(HBV)
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX02A00Initial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0851144
Page 102 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.b Exclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with human immuno
deficiency virus (HIV), hepatitis C vir
us (HCV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Desc
ription:History of severe adverse re
action associated with a vac
cine and/or severe allergic re
action (eg, anaphylaxis) to a
ny component of the study i
ntervention(s)Initial Entry
090177e196ae4057\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-2021-5683-0851145
Page 103 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adverse reaction ass
ociated with a vaccine and/or severe al
lergic reaction (eg, anaphylaxis) to an
y component of the study intervention
(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
090177e196ae4057\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)
FDA-CBER-2021-5683-0851146
Page 104 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:4
Criterion Des
cription:Receipt of medicatio
ns intended to preven
t COVID-19
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX04A00Initial Entry
2.d Exclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of medications intended to pre
vent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
090177e196ae4057\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-2021-5683-0851147
Page 105 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:8
Criterio
n Descr
iption:Immunocompromised indivi
duals with known or suspect
ed immunodeficiency, as de
termined by history and/or l
aboratory/physical examinat
ion
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX08A00Initial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851148
Page 106 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.e Exclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised individuals wit
h known or suspected immunodeficien
cy, as determined by history and/or lab
oratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:10
Criteri
on Desc
ription:Bleeding diathesis or conditi
on associated with prolonge
d bleeding that would, in the
opinion of the investigator, c
ontraindicate intramuscular i
njectionInitial Entry
090177e196ae4057\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-2021-5683-0851149
Page 107 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition associ
ated with prolonged bleeding that wou
ld, in the opinion of the investigator, c
ontraindicate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Sep-05-2020 16:36:56 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4057\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)
FDA-CBER-2021-5683-0851150
Page 108 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City of
Buenos AiresExclusion Num
ber:11
Criterion Descri
ption:Women who are pr
egnant or breastfee
ding
Criterion met?: NO
Criterion ID: (F
or Pfizer use onl
y):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are pregnant or breastfee
dingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
090177e196ae4057\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-2021-5683-0851151
Page 109 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12
Criterion Desc
ription:Previous vaccination
with any coronavirus
vaccine
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX12A00Initial Entry
2.h Exclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with any corona
virus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
090177e196ae4057\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-2021-5683-0851152
Page 110 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:13
Criterion
Descripti
on:Subjects who receive imm
unosuppressive therapy, s
uch as cytotoxic agents or
systemic corticosteroids
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX13A01Initial Entry
2.i Exclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immunosuppress
ive therapy, such as cytotoxic agents o
r systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
090177e196ae4057\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-2021-5683-0851153
Page 111 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.j
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:15
Criteri
on Desc
ription:Receipt of blood/plasma pro
ducts or immunoglobulin, fr
om 60 days before study int
ervention administration or
planned receipt throughout t
he study
Criteri
on met?
:NO
Criteri
on ID: (
For Pfi
zer use
only):EX14A01Initial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851154
Page 112 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.j Exclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products or i
mmunoglobulin, from 60 days before
study intervention administration or pl
anned receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae4057\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)
FDA-CBER-2021-5683-0851155
Page 113 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
2.k
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other studi
es involving study interven
tion within 28 days prior to
study entry and/or during s
tudy participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX15A01Initial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851156
Page 114 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.k Exclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other studies involvin
g study intervention within 28 days pr
ior to study entry and/or during study
participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in
other studies involving st
udy intervention containi
ng lipid nanoparticles
Criterion
met?:NOInitial Entry
090177e196ae4057\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-2021-5683-0851157
Page 115 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterion
ID: (For
Pfizer use
only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participation in other studies
involving study intervention containin
g lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:22Initial Entry
090177e196ae4057\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-2021-5683-0851158
Page 116 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on Des
criptio
n:Investigator site staff or Pfiz
er employees directly involv
ed in the conduct of the stud
y, site staff otherwise supervi
sed by the investigator, and t
heir respective family memb
ers
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX21A01
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851159
Page 117 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.m Exclusion Number:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Sep-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer emplo
yees directly involved in the conduct
of the study, site staff otherwise super
vised by the investigator, and their res
pective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Sep-05-2020 16:36:56
(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-05-2020 16:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae4057\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)
FDA-CBER-2021-5683-0851160
Page 118 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 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-05-2020 16:37:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-05-2020 16:37:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-05-2020 16:37:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851161
Page 119 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-05-2020 16:41:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/5/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-05-2020 16:41:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
68.8Initial Entry
3. Unit:
Date Location User Value Reason
Sep-05-2020 16:41:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-05-2020 16:41:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
169.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-05-2020 16:41:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae4057\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-2021-5683-0851162
Page 120 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-05-2020 16:41:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24.1Initial Entry
7.a
Date Location User Value Reason
Sep-05-2020 16:41:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Location
::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-05-2020 16:41:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-05-2020 16:41:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-05-2020 16:41:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-05-2020 16:41:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae4057\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-2021-5683-0851163
Page 121 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-05-2020 16:42:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/5/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-05-2020 16:42:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
82803Initial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851164
Page 122 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020 11:42:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020 11:42:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020 11:42:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-07-2020 11:42:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-07-2020 11:42:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/5/2020Initial Entry
5.a
Date Location User Value Reason
Sep-07-2020 11:42:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPTJPMInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851165
Page 123 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020 11:42:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BPTJPMInitial Entry
5.b
Date Location User Value Reason
Sep-07-2020 11:42:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPTJPNInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-07-2020 11:42:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BPTJPNInitial Entry
5.c
Date Location User Value Reason
Sep-07-2020 11:42:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPTJPPInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-07-2020 11:42:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BPTJPPInitial Entry
5.d
Date Location User Value Reason
Sep-07-2020 11:42:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPHNWKInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-07-2020 11:42:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BPHNWKInitial Entry
090177e196ae4057\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851166
Page 124 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.e
Date Location User Value Reason
Sep-07-2020 11:43:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPHNWLInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-07-2020 11:43:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BPHNWLInitial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851167
Page 125 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020 11:28:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020 11:28:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020 11:28:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-07-2020 11:28:13
(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-07-2020 11:28:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/5/2020Initial Entry
5.a
Date Location User Value Reason
Sep-07-2020 11:28:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPTJP6Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851168
Page 126 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020 11:28:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BPTJP6Initial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851169
Page 127 of 185
***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: 12261571 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-05-2020 16:42:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-05-2020 16:42:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-05-2020 16:42:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-05-2020 16:42:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/5/2020 15:08Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-05-2020 16:42:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-05-2020 16:42:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851170
Page 128 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7. Route:
Date Location User Value Reason
Sep-05-2020 16:42:59
(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-05-2020 16:42:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-05-2020 16:42:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851171
Page 129 of 185
***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: 12261571 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-05-2020 16:43:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851172
Page 130 of 185
***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: 12261571 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-25-2020 14:24:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851173
Page 131 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020 14:24:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2.a
Date Location User Value Reason
Sep-25-2020 14:24:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Location
::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-25-2020 14:24:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-25-2020 14:24:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-25-2020 14:24:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-25-2020 14:24:32
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae4057\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-2021-5683-0851174
Page 132 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851175
Page 133 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 17:34:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 17:34:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020 17:34:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-25-2020 17:34:23
(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-25-2020 17:34:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020 17:34:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP7X9XInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851176
Page 134 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-25-2020 17:34:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BP7X9XInitial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851177
Page 135 of 185
***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: 12261571 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-25-2020 14:26:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020 14:26:36
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020 14:26:36
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-25-2020 14:26:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020 09:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020 14:26:36
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-25-2020 14:26:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851178
Page 136 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-25-2020 14:26:36
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-25-2020 14:26:36
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-25-2020 14:26:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851179
Page 137 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-30-2020
03:38:08
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
1: Clo
sedClosed as per site response,
updated PD tracker for clinical
review
Nov-27-2020
07:22:27
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
1: Ans
weredThe date is correct. Subject
came out of the window due
unavailability.
Nov-27-2020
02:44:53
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 27 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately.
Nov-26-2020
12:15:10
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data
Entry
:
Nov/2
6/202
0Initial Entry
090177e196ae4057\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) (4)
FDA-CBER-2021-5683-0851180
Page 138 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-26-2020 16:51:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-26-2020 16:51:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-26-2020 16:51:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-26-2020 16:51:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-26-2020 16:51:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/26/2020Initial Entry
5.a
Date Location User Value Reason
Nov-26-2020 16:51:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR60GDInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851181
Page 139 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-26-2020 16:51:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR60GDInitial Entry
5.b
Date Location User Value Reason
Nov-26-2020 16:52:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BS2Y0NInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-26-2020 16:52:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BS2Y0NInitial Entry
5.c
Date Location User Value Reason
Nov-26-2020 16:52:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BS2Y0PInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-26-2020 16:52:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BS2Y0PInitial Entry
090177e196ae4057\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-2021-5683-0851182
Page 140 of 185
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-26-2020 12:15:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-26-2020 12:15:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-26-2020 12:15:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851183
Page 141 of 185
***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: 12261571 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-11-2021 17:44:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/9/2021Initial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851184
Page 142 of 185
***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: 12261571 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-11-2021 17:44:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing to return for Vac
cination 3
Participant is:
eligible and NOT confirmed to ha
ve received only placebo at Vaccin
ation 1/2Initial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851185
Page 143 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Oct-27-2020 17:00:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851186
Page 144 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Oct-27-2020 17:01:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851187
Page 145 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Oct-27-2020 17:03:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851188
Page 146 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Oct-27-2020 17:05:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851189
Page 147 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Oct-27-2020 17:05:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851190
Page 148 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Oct-27-2020 17:06:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851191
Page 149 of 185
***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: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Oct-30-2020 07:39:00
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851192
Page 150 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 17:00:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 17:00:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-27-2020 17:00:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Excoriations in various regions of the b
odyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 17:00:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-05-2020 17:48:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/30/2020 UNK:UNKNew Information
Oct-27-2020 17:00:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4057\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)
FDA-CBER-2021-5683-0851193
Page 151 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-27-2020 17:00:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-27-2020 17:00:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-27-2020 17:00:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-27-2020 17:00:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
hit by motorcycleInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-27-2020 17:00:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae4057\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-2021-5683-0851194
Page 152 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Oct-27-2020 17:00:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-27-2020 17:00:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-05-2020 17:51:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-05-2020 17:51:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-05-2020 17:48:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Excoriations in
various regions of the
body: Response to
"What was the outcome
of this adverse event?"
is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-27-2020 17:00:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020 17:00:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4057\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-2021-5683-0851195
Page 153 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 17:01:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 17:01:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-27-2020 17:01:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Bruises in various regions of the bodyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 17:01:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-05-2020 17:48:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/30/2020 UNK:UNKNew Information
Oct-27-2020 17:01:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4057\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)
FDA-CBER-2021-5683-0851196
Page 154 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-27-2020 17:01:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-27-2020 17:01:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-27-2020 17:01:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-27-2020 17:01:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
hit by motorcycleInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-27-2020 17:01:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae4057\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) (6)
FDA-CBER-2021-5683-0851197
Page 155 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Oct-27-2020 17:01:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-27-2020 17:01:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-05-2020 17:51:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-05-2020 17:51:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-05-2020 17:48:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Bruises in
various regions of the
body: Response to
"What was the outcome
of this adverse event?"
is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-27-2020 17:01:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020 17:01:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4057\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-2021-5683-0851198
Page 156 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 17:03:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 17:03:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-27-2020 17:03:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Peri-renal hematomaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 17:03:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-05-2020 17:48:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/30/2020 UNK:UNKNew Information
Oct-27-2020 17:03:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4057\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)
FDA-CBER-2021-5683-0851199
Page 157 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-27-2020 17:03:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-29-2020 09:28:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed recorded under
AER2020418631
Oct-29-2020 09:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-29-2020 06:08:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Candidate SAE RECON: Pending
PSSR confirmation if
SAE form was receive
Oct-28-2020 16:17:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered As instructed by CRA,
all the SAE were at the
same document sent to
Safety database. They
are starting at page 3,
and the name of the
SAE is reported on
item 10. The report
was sent on 27/Oct
/2020.
Oct-28-2020 06:59:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened SAE RECON:
Peri-renal
hematoma(Onset
date:21Oct2020) is not
reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
090177e196ae4057\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-2021-5683-0851200
Page 158 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-27-2020 17:03:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Peri-renal
hematoma: Response
to "Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-27-2020 17:03:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated with
congenital anomaly or birth defect?
NO
Did this serious event result in deat
h?
NO
Did this serious event require or pro
long hospitalization?
YES
Did this serious event result in persi
stent or significant disability/incapa
city?
NO
Is this serious event life threatening
?
NO
Other medically important serious e
vent
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-27-2020 17:03:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851201
Page 159 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-27-2020 17:03:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
hit by motorcycleInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-27-2020 17:03:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-27-2020 17:03:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-27-2020 17:03:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-05-2020 17:51:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-05-2020 17:51:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
090177e196ae4057\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-2021-5683-0851202
Page 160 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-05-2020 17:48:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE Peri-renal hematoma:
Response to "What was the outcome
of this adverse event?" is 'Not
Recovered/Not Resolved' but AE
End Date/Time is present.
Oct-31-2020 11:05:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-30-2020 11:21:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-30-2020 11:21:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT
RESOLVEDTranscription Error
Oct-30-2020 08:57:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020418631,outcome
was reported as NOT
RECOVERED/NOT RESOLVED to
Safety DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Oct-27-2020 17:03:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVI
NGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020 17:03:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-29-2020 09:25:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
2020418631Initial Entry
090177e196ae4057\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-2021-5683-0851203
Page 161 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 17:05:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 17:05:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-27-2020 17:05:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Subarachnoid hemorrhageInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 17:05:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-05-2020 17:49:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/30/2020 UNK:UNKNew Information
Oct-27-2020 17:05:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4057\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)
FDA-CBER-2021-5683-0851204
Page 162 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-27-2020 17:05:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-29-2020 09:28:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed recorded under
AER2020418631
Oct-29-2020 06:08:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Candidate SAE RECON: Pending
PSSR confirmation if
SAE form was receive
Oct-28-2020 16:17:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered As instructed by CRA,
all the SAE were at the
same document sent to
Safety database. They
are starting at page 3,
and the name of the
SAE is reported on
item 10. The report was
sent on 27/Oct/2020.
Oct-28-2020 07:02:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Deleted Query can be addressed
internally
Oct-28-2020 06:59:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened SAE RECON:
Subarachnoid
hemorrhage(Onset
date:21Oct2020) is not
reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Oct-27-2020 17:05:03
(UTC-03:00) City ofACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Subarachnoid
hemorrhage: Response
090177e196ae4057\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-2021-5683-0851205
Page 163 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires to "Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-27-2020 17:05:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated with
congenital anomaly or birth defect?
NO
Did this serious event result in deat
h?
NO
Did this serious event require or pro
long hospitalization?
YES
Did this serious event result in persi
stent or significant disability/incapa
city?
NO
Is this serious event life threatening
?
NO
Other medically important serious e
vent
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-27-2020 17:05:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851206
Page 164 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-30-2020 16:03:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Thank you.
Oct-30-2020 07:42:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered information updated
Oct-29-2020 20:54:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Per CRF Completion
Guidelines section
8.50.2.1. "When an
MVA results in an
injury, both the injury
and the MVA should
be recorded as AEs."
Please revise/update
accordingly. Thank
you.
Oct-27-2020 17:05:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s),
this event is due to:
OTHER
If Other, specify:
hit by motorcycleInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-27-2020 17:05:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-27-2020 17:05:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae4057\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) (4)
FDA-CBER-2021-5683-0851207
Page 165 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-27-2020 17:05:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-05-2020 17:49:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-05-2020 17:49:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-05-2020 17:49:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE Subarachnoid hemorrhage:
Response to "What was the outcome
of this adverse event?" is 'Not
Recovered/Not Resolved' but AE
End Date/Time is present.
Oct-31-2020 11:05:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-30-2020 11:21:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-30-2020 11:21:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT
RESOLVEDTranscription Error
Oct-30-2020 08:58:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020418631,outcome
was reported as NOT
RECOVERED/NOT RESOLVED to
Safety DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Oct-27-2020 17:05:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVI
NGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae4057\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-2021-5683-0851208
Page 166 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Oct-27-2020 17:05:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-29-2020 09:25:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
2020418631Initial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851209
Page 167 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 17:05:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 17:05:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-27-2020 17:05:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Fracture of the fourth cervical vertebraInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 17:05:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-05-2020 17:50:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/30/2020 UNK:UNKNew Information
Oct-27-2020 17:05:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4057\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)
FDA-CBER-2021-5683-0851210
Page 168 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-27-2020 17:05:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-02-2020 14:58:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle
CastilloQuery 3: Closed Thank you.
Oct-30-2020 16:52:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Answered This information will
be included in the next
follow up
Oct-30-2020 16:04:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle
CastilloQuery 3: Reissued:Opened If test was NOT done
or NOT available,
please summit FU
report so this
information is added to
the case narrative as
well. Thanks
Oct-30-2020 07:42:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Answered Any SARS-CoV-2 test
were performed
Oct-29-2020 20:59:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle
CastilloQuery 3: Opened Kindly confirm if any
SARS-CoV-2 (NAAT
or other) tests were
performed on the SAE
submitted to safety. If
test performed = YES,
please provide FU
report with results. If
test was NOT done or
NOT available, please
FU as well. Thanks
Oct-29-2020 09:28:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed recorded under
AER2020418631
090177e196ae4057\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) (4)
(b) (4)
FDA-CBER-2021-5683-0851211
Page 169 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-29-2020 06:08:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Candidate SAE RECON: Pending
PSSR confirmation if
SAE form was receive
Oct-28-2020 16:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered As instructed by CRA,
all the SAE were at the
same document sent to
Safety database. They
are starting at page 3,
and the name of the
SAE is reported on
item 10. The report
was sent on 27/Oct
/2020.
Oct-28-2020 07:02:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Deleted Query can be
addressed internally
Oct-28-2020 07:00:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened SAE RECON: Fracture
of the fourth cervical
vertebra(Onset
date:21Oct2020) is not
reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Oct-27-2020 17:05:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Fracture of the
fourth cervical
vertebra: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-27-2020 17:05:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated with
congenital anomaly or birth defect?
NO
Did this serious event result in deat
h?Initial Entry
090177e196ae4057\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-2021-5683-0851212
Page 170 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
NO
Did this serious event require or pro
long hospitalization?
YES
Did this serious event result in persi
stent or significant disability/incapa
city?
NO
Is this serious event life threatening
?
NO
Other medically important serious e
vent
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-27-2020 17:05:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-27-2020 17:05:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
hit by motorcycleInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851213
Page 171 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-27-2020 17:05:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-27-2020 17:05:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-27-2020 17:05:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-05-2020 17:50:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-05-2020 17:50:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-05-2020 17:50:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE Fracture of the fourth
cervical vertebra: Response to
"What was the outcome of this
adverse event?" is 'Not
Recovered/Not Resolved' but AE
End Date/Time is present.
Oct-31-2020 11:05:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-30-2020 11:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-30-2020 11:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT
RESOLVEDTranscription Error
090177e196ae4057\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-2021-5683-0851214
Page 172 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-30-2020 08:56:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020418631,outcome
was reported as NOT
RECOVERED/NOT RESOLVED to
Safety DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Oct-27-2020 17:05:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVI
NGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020 17:05:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-29-2020 09:25:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
2020418631Initial Entry
090177e196ae4057\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)
FDA-CBER-2021-5683-0851215
Page 173 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 17:06:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 17:06:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-27-2020 17:06:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Cervical spinal cord contusionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 17:06:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-05-2020 17:50:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/30/2020 UNK:UNKNew Information
Oct-27-2020 17:06:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4057\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)
FDA-CBER-2021-5683-0851216
Page 174 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-27-2020 17:06:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-29-2020 09:28:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed recorded under
AER2020418631
Oct-29-2020 06:08:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Candidate SAE RECON: Pending
PSSR confirmation if
SAE form was receive
Oct-28-2020 16:17:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered As instructed by CRA,
all the SAE were at the
same document sent to
Safety database. They
are starting at page 3,
and the name of the
SAE is reported on
item 10. The report
was sent on 27/Oct
/2020.
Oct-28-2020 07:02:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Deleted Query can be
addressed internally
Oct-28-2020 07:00:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened SAE RECON: Cervical
spinal cord
contusion(Onset
date:21Oct2020) is not
reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
090177e196ae4057\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-2021-5683-0851217
Page 175 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-27-2020 17:06:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Cervical spinal
cord contusion:
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event
Number" is blank.
Oct-27-2020 17:06:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated with
congenital anomaly or birth defect?
NO
Did this serious event result in deat
h?
NO
Did this serious event require or pro
long hospitalization?
YES
Did this serious event result in persi
stent or significant disability/incapa
city?
NO
Is this serious event life threatening
?
NO
Other medically important serious e
vent
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-27-2020 17:06:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851218
Page 176 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-01-2020
05:49:02
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-30-2020
07:43:12
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Answe
redinformation
updated
Oct-29-2020
07:10:35
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1: Opene
dPlease review
"If not related to
study treatment
other" field, the
following text
was indicated in
the comment
field [hit by
motorcycle].
Any symptoms,
AEs or other
key data should
be collected on
the appropriate
page. Please
review and
update as
necessary.
Oct-27-2020
17:06:59
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related
to study treatm
ent(s), this eve
nt is due to:
OTHER
If Other, sp
ecify:
hit by mot
orcycleInitial Entry
090177e196ae4057\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) (4)
FDA-CBER-2021-5683-0851219
Page 177 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-27-2020 17:06:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-27-2020 17:06:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-27-2020 17:06:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-05-2020 17:50:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-05-2020 17:50:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-05-2020 17:50:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE Cervical spinal cord
contusion: Response to "What was
the outcome of this adverse event?"
is 'Not Recovered/Not Resolved' but
AE End Date/Time is present.
Oct-31-2020 11:05:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-30-2020 11:22:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-30-2020 11:22:29
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOTTranscription Error
090177e196ae4057\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-2021-5683-0851220
Page 178 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires RESOLVED
Oct-30-2020 08:56:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020418631,outcome
was reported as NOT
RECOVERED/NOT RESOLVED to
Safety DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Oct-27-2020 17:06:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVI
NGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020 17:06:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-29-2020 09:25:36
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
2020418631Initial Entry
090177e196ae4057\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)
FDA-CBER-2021-5683-0851221
Page 179 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261571 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Oct-30-2020 07:39:00
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-30-2020 07:39:00
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-30-2020 07:39:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
hit by motorcycleInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-30-2020 07:39:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/21/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-30-2020 07:39:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/21/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4057\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6
…[truncated]