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: 12261477 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
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850623
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/27/2020
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850624
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12261477]
2.Birth Date: /1944
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850625
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850626
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: 12261477 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
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850627
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes
compliance with the requirements and restrictions listed in the ICD and
in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or
active suicidal ideation/behavior/lab abnormality that may increase the
risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C
virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or
severe allergic reaction (eg, anaphylaxis) to any component of the study
intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX03A00
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850628
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or laboratory/physical
examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that
would, in the opinion of the investigator, contraindicate intramuscular
injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850629
Page 8 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: 12261477 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
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850630
Page 9 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850631
Page 10 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850632
Page 11 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Systemic arterial hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Inclusion body myositis]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850633
Page 12 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [67.3]
3.Unit: kg
4.Height: [165.0]
5.Unit: cm
6.Body Mass Index: [24.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850634
Page 13 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [242949]
3.Randomization Group: [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850635
Page 14 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPT0LC]
5.bSample ID [BPT0LB]
5.cSample ID [BPT0L9]
5.dSample ID [BLCT5Y]
5.eSample ID [BLCT5X]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850636
Page 15 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9DLS]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850637
Page 16 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 14:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850638
Page 17 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: 12261477 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
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850639
Page 18 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/19/2020
2.Erroneous Visit
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850640
Page 19 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850641
Page 20 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: 12261477 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/19/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP7X2J]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850642
Page 21 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: 12261477 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/19/2020 12:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850643
Page 22 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850644
Page 23 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
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 [BS857M]
5.bSample ID [BS857L]
5.cSample ID [BR6NL9]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850645
Page 24 of 185
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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:
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850646
Page 25 of 185
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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: [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850647
Page 26 of 185
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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 [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850648
Page 27 of 185
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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 [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850649
Page 28 of 185
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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?
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850650
Page 29 of 185
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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:
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850651
Page 30 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: 12261477 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:
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850652
Page 31 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: 12261477 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 [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850653
Page 32 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850654
Page 33 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850655
Page 34 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850656
Page 35 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: 12261477 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: [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850657
Page 36 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: 12261477 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:
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850658
Page 37 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: 12261477 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 [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850659
Page 38 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850660
Page 39 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: 12261477 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:
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850661
Page 40 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: 12261477 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?
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850662
Page 41 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850663
Page 42 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850664
Page 43 of 185
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/23/2021
2.Erroneous Visit
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850665
Page 44 of 185
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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 per local/national recommendations and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850666
Page 45 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850667
Page 46 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/5/2021
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850668
Page 47 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850669
Page 48 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Mar/5/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850670
Page 49 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/5/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGZ33]
5.bSample ID [BRXW67]
5.cSample ID [BRXW65]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850671
Page 50 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/5/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGZ1D]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850672
Page 51 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/5/2021 10:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850673
Page 52 of 185
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/25/2021
2.Erroneous Visit
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850674
Page 53 of 185
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12261477 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 [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850675
Page 54 of 185
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/25/2021 08:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850676
Page 55 of 185
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850677
Page 56 of 185
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850678
Page 57 of 185
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850679
Page 58 of 185
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850680
Page 59 of 185
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850681
Page 60 of 185
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850682
Page 61 of 185
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850683
Page 62 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Appendicitis Jan/12/2021 UN
K:UNK NO
End Date Time:
Jan/21/2021 UNK:UN
K
Repeating
Pages
2.ADVERSE E
VENT 2 pain at the inject
ion site Mar/5/2021 18:0
0 NO
End Date Time:
Mar/6/2021 UNK:UN
K
Repeating
Pages
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850684
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Appendicitis]
4.Start Date Time: Jan/12/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/21/2021 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850685
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021070160]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850686
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
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[pain at the injection site]
4.Start Date Time: Mar/5/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/6/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).NO
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850687
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
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850688
Page 67 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Catego
ryMedication
ErrorStart D
ateIs the medication error Sti
ll OngoingStudy Medication Erro
rs ActionForm Instanc
e
1. Repeating
Pages
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850689
Page 68 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: 12261477 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[ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850690
Page 69 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart
DateForm Instanc
e
1. Repeating
Pages
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850691
Page 70 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: 12261477 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: //
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850692
Page 71 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850693
Page 72 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: 12261477 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?
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850694
Page 73 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Catego
ryTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850695
Page 74 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: 12261477 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?
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850696
Page 75 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850697
Page 76 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850698
Page 77 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/23/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850699
Page 78 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850700
Page 79 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: 12261477 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: [ ]
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850701
Page 80 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/21/2020
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850702
Page 81 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, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850703
Page 82 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, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850704
Page 83 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormMar-05-2021 12:26:59 (UTC-03:00) City
of Buenos AiresNot Applicable
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850705
Page 84 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, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-25-2021 16:24:05 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Mar-08-2021 08:53:20 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-05-2021 16:37:53 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Mar-05-2021 15:43:35 (UTC-03:00) City
of Buenos AiresBOOK Signed
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850706
Page 85 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, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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 Mar-05-2021 12:26:18 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Feb-11-2021 11:29:16 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-10-2021 05:50:08 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Feb-03-2021 18:09:34 (UTC-03:00) City
of Buenos AiresBOOK Signed
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850707
Page 86 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, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-25-2021 15:17:56 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Oct-28-2020 09:46:07 (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.
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850708
Page 87 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-28-2020 09:22:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-28-2020 09:22:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850709
Page 88 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 09:23:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Aug/27/2020Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850710
Page 89 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020 09:22:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12261477Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020 09:22:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1944Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020 09:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 09:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020 09:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850711
Page 90 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020 09:23:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850712
Page 91 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclu
sion
Num
ber:1
Crite
rion
Desc
riptio
n:Male or female partic
ipants between the ag
es of 18 and 55 years,
inclusive, 65 and 85
years, inclusive, or 1
8 and 85 years, inclus
ive, at randomization
(dependent upon stud
y stage)
Crite
rion
met?
:YES
Crite
rion
ID: (
For
Pfize
r use
only)
:IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850713
Page 92 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires
1.a Criterion Description:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Male or female participants b
etween the ages of 18 and 55
years, inclusive, 65 and 85 y
ears, inclusive, or 18 and 85
years, inclusive, at randomiz
ation (dependent upon study
stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclu
sion
Num
ber:2Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850714
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crite
rion
Descr
iption
:Participants who are
willing and able to c
omply with all sched
uled visits, vaccinati
on plan, laboratory te
sts, lifestyle consider
ations, and other stud
y procedures
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer us
e only
):IN02A00
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850715
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Inclusion Number:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are willing
and able to comply with all s
cheduled visits, vaccination
plan, laboratory tests, lifestyl
e considerations, and other st
udy proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-28-2020 09:23:53 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850716
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City of
Buenos AiresInclu
sion
Num
ber:3
Crite
rion
Descr
iption
:Healthy participants
who are determined
by medical history, p
hysical examination,
and clinical judgmen
t of the investigator t
o be eligible for inclu
sion in the study
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer us
e only
):IN03A00
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850717
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.c Inclusion Number:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants who are
determined by medical histor
y, physical examination, and
clinical judgment of the inve
stigator to be eligible for incl
usion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-28-2020 09:23:53 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850718
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City of
Buenos AiresInclus
ion N
umbe
r:4
Crite
rion
Descr
iption
:Capable of giving pe
rsonal signed inform
ed consent, which in
cludes compliance w
ith the requirements
and restrictions liste
d in the ICD and in t
his protocol
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer us
e only
):IN04A00
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850719
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.d Inclusion Number:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal si
gned informed consent, whic
h includes compliance with t
he requirements and restricti
ons listed in the ICD and in t
his protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-28-2020 09:23:53 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850720
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City of
Buenos AiresExclu
sion
Num
ber:1
Crite
rion
Descr
iption
:Other medical or psy
chiatric condition inc
l. recent (within past
year) or active suicid
al ideation/behavior/l
ab abnormality that
may increase the risk
of study participation
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatric
condition incl. recent (within
past year) or active suicidal iInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850721
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
deation/behavior/lab abnorm
ality that may increase the ris
k of study participation
2.a Criterion met?
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Known infection wi
th human immunod
eficiency virus (HI
V), hepatitis C viru
s (HCV), or hepatiti
s B virus (HBV)
Criteri
on met
?:NOInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850722
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on ID:
(For Pf
izer us
e only)
:EX02A00
2.b Exclusion Number:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with human
immunodeficiency virus (HI
V), hepatitis C virus (HCV),
or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850723
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.c
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion
Num
ber:3
Crite
rion
Descr
iption
:History of severe ad
verse reaction associ
ated with a vaccine a
nd/or severe allergic
reaction (eg, anaphyl
axis) to any compon
ent of the study inter
vention(s)
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX03A00Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850724
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.c Exclusion Number:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adverse rea
ction associated with a vacci
ne and/or severe allergic reac
tion (eg, anaphylaxis) to any
component of the study inter
vention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-28-2020 09:23:53 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850725
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City of
Buenos AiresExclusion
Number:4
Criterion
Descriptio
n:Receipt of medi
cations intende
d to prevent CO
VID-19
Criterion
met?:NO
Criterion I
D: (For Pfi
zer use onl
y):EX04A00
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850726
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.d Exclusion Number:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of medications inten
ded to prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:8Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850727
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criter
ion D
escrip
tion:Immunocompromise
d individuals with k
nown or suspected i
mmunodeficiency, a
s determined by hist
ory and/or laborator
y/physical examinati
on
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX08A00
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850728
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.e Exclusion Number:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised indivi
duals with known or suspect
ed immunodeficiency, as det
ermined by history and/or la
boratory/physical examinatio
nInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-28-2020 09:23:53 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850729
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City of
Buenos AiresExclu
sion
Num
ber:10
Criter
ion D
escrip
tion:Bleeding diathesis or
condition associated
with prolonged bleed
ing that would, in th
e opinion of the inve
stigator, contraindica
te intramuscular inje
ction
Criter
ion m
et?:NO
Criter
ion I
D: (F
or Pfi
zer us
e only
):EX10A00
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850730
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.f Exclusion Number:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or conditi
on associated with prolonged
bleeding that would, in the o
pinion of the investigator, co
ntraindicate intramuscular inj
ectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-28-2020 09:23:53 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850731
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City of
Buenos AiresExclusion N
umber:11
Criterion D
escription:Women who a
re pregnant or
breastfeeding
Criterion m
et?:NO
Criterion I
D: (For Pfiz
er use only)
:EX11A00
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0850732
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.g Exclusion Number:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are pregnant or
breastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:12Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850733
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterion
Descriptio
n:Previous vacci
nation with any
coronavirus va
ccine
Criterion
met?:NO
Criterion I
D: (For Pfi
zer use onl
y):EX12A00
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850734
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.h Exclusion Number:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with an
y coronavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:13Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850735
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on Desc
ription:Subjects who recei
ve immunosuppres
sive therapy, such a
s cytotoxic agents
or systemic cortico
steroids
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX13A01
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850736
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.i Exclusion Number:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immun
osuppressive therapy, such as
cytotoxic agents or systemic
corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion15Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850737
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Numb
er:
Criter
ion D
escrip
tion:Receipt of blood/pla
sma products or imm
unoglobulin, from 6
0 days before study i
ntervention administ
ration or planned rec
eipt throughout the s
tudy
Criter
ion m
et?:NO
Criter
ion I
D: (F
or Pfi
zer us
e only
):EX14A01
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850738
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.j Exclusion Number:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma pro
ducts or immunoglobulin, fro
m 60 days before study inter
vention administration or pla
nned receipt throughout the s
tudyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 09:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850739
Page 118 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
2.k
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:16
Criter
ion De
scripti
on:Participation in oth
er studies involving
study intervention
within 28 days prio
r to study entry and/
or during study part
icipation
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX15A01Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850740
Page 119 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.k Exclusion Number:
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other studies
involving study intervention
within 28 days prior to study
entry and/or during study pa
rticipationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)ACV0PFEINFP6000 Data Entry:
Exclusi17Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850741
Page 120 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
City of Buenos Aires on Nu
mber:
Criteri
on Desc
ription:Previous participat
ion in other studie
s involving study i
ntervention contai
ning lipid nanopar
ticles
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX16A01
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0850742
Page 121 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.l Exclusion Number:
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participation in oth
er studies involving study int
ervention containing lipid na
noparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usion22Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850743
Page 122 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Num
ber:
Crite
rion
Desc
riptio
n:Investigator site staff
or Pfizer employees
directly involved in t
he conduct of the stu
dy, site staff otherwis
e supervised by the i
nvestigator, and their
respective family me
mbers
Crite
rion
met?
:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX21A01
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850744
Page 123 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.m Exclusion Number:
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfiz
er employees directly involv
ed in the conduct of the stud
y, site staff otherwise superv
ised by the investigator, and
their respective family mem
bersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020
09:23:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850745
Page 124 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-28-2020 09:24:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020 09:24:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020 09:24:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850746
Page 125 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020 09:25:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Systemic arteri
al hypertension
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020 09:25:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 09:25:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Systemic arterial hypertensio
nInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020 09:25:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850747
Page 126 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020 09:25:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-29-2020
15:09:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Inclusion bo
dy myositis
Start Date: UNK/UNK/
2010
Ongoing: YESTranscription
Error
Aug-28-2020
09:26:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:inclusion bod
y myopathy
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850748
Page 127 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020 09:26:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-29-2020
23:46:26
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clos
edDiscrepancy
has been
closed.
Aug-29-2020
15:09:49
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredTranscription
Error
Aug-29-2020
15:09:49
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data E
ntry:
Inclusi
on bod
y myos
itisTranscription
Error
Aug-28-2020
20:55:57
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Ope
nedClarify
INCLUSION
BODY
MYOPATHY
as
follows...Term
is unclear. Are
you reporting
HEREDITARY
INCLUSION
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0850749
Page 128 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
BODY
MYOPATHY?
Or
INCLUSION
BODY
MYOSITIS?
Or other?
Please update
the verbatim
term to clarify.
Thank you.
Aug-28-2020
09:26:50
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data E
ntry:
inclusi
on bod
y myop
athyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020 09:26:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020 09:26:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850750
Page 129 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 09:27:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 09:27:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
67.3Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 09:27:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 09:27:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
165.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 09:27:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850751
Page 130 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020 09:27:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24.7Initial Entry
7.a
Date Location User Value Reason
Aug-28-2020 09:27:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 36.6
Temperature Un
it:C
Temperature Lo
cation::FOREH
EADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 09:27:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020 09:27:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850752
Page 131 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-28-2020 09:27:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020 09:27:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850753
Page 132 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020 09:31:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020 09:31:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
242949Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850754
Page 133 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 10:02:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 10:02:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
10:02:34 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020
10:02:19 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-28-2020
10:02:19 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850755
Page 134 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a
Date Location User Value Reason
Aug-28-2020 10:02:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPT0LCInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 10:02:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPT0LCInitial Entry
5.b
Date Location User Value Reason
Aug-28-2020 10:02:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPT0LBInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020 10:02:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPT0LBInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020 10:02:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPT0L9Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850756
Page 135 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.c Sample ID
Date Location User Value Reason
Aug-28-2020 10:02:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPT0L9Initial Entry
5.d
Date Location User Value Reason
Aug-28-2020 10:03:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLCT5YInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-28-2020 10:03:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLCT5YInitial Entry
5.e
Date Location User Value Reason
Aug-28-2020 10:03:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLCT5XInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-28-2020 10:03:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLCT5XInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850757
Page 136 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 09:59:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 09:59:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
09:59:14 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020
09:59:04 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-28-2020
09:59:04 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850758
Page 137 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a
Date Location User Value Reason
Aug-28-2020 09:59:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP9DLSInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 09:59:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP9DLSInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850759
Page 138 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020 09:31:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 09:31:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 09:31:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020 09:31:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/27/2020 14:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 09:31:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850760
Page 139 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
6. Body Side:
Date Location User Value Reason
Aug-28-2020 09:31:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-28-2020 09:31:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020 09:31:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-28-2020 09:31:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850761
Page 140 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020 09:32:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLECTE
D FOR THIS SUBJECTInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850762
Page 141 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: 12261477 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-19-2020
14:32:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850763
Page 142 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-19-2020
14:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020Initial Entry
2.a
Date Location User Value Reason
Sep-19-2020
14:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifi
er::1
Temperature: 36.4
Temperature U
nit:C
Temperature L
ocation::FOREH
EADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-19-2020
14:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-19-2020
14:32:53
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
36.4Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850764
Page 143 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires
2.a Unit:
Date Location User Value Reason
Sep-19-2020
14:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-19-2020
14:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850765
Page 144 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-19-2020 16:23:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-19-2020 16:23:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-19-2020
16:23:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-19-2020
16:23:52
(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-19-2020
16:23:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/19/2020Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850766
Page 145 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a
Date Location User Value Reason
Sep-19-2020 16:23:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP7X2JInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-19-2020 16:23:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP7X2JInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850767
Page 146 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: 12261477 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-19-2020
14:33:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-19-2020 14:33:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-19-2020 14:33:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-19-2020
14:33:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020 12:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-19-2020 14:33:23
(UTC-03:00) City ofACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850768
Page 147 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires
6. Body Side:
Date Location User Value Reason
Sep-19-2020
14:33:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-19-2020 14:33:23
(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-19-2020 14:33:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-19-2020
14:33:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850769
Page 148 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-21-2020 14:47:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850770
Page 149 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 17:46:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 17:46:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020
17:46:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-21-2020
17:46:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-21-2020
17:46:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0850771
Page 150 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a
Date Location User Value Reason
Oct-21-2020
17:46:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BS857MInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020
17:46:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BS857MInitial Entry
5.b
Date Location User Value Reason
Oct-21-2020
17:46:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BS857LInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020
17:46:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BS857LInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850772
Page 151 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
17:46:59
(UTC-03:00) City of
Buenos AiresSample ID: BR6NL9
5.c Sample ID
Date Location User Value Reason
Oct-21-2020
17:46:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR6NL9Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0850773
Page 152 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-21-2020 14:48:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020 14:48:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020 14:48:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850774
Page 153 of 185
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-25-2021 15:19:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/23/2021Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850775
Page 154 of 185
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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
Mar-05-2021
15:28:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-05-2021
12:27:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Data updated.
Mar-04-2021
03:23:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: Participant
is eligible and
confirmed to
have received
Placebo, but
Date Written
Consent
Obtained is
missing in
Informed
Consent - Further
Vaccination CRF.
Please review
and update as
appropriate.
Jan-25-2021
15:20:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing to re
turn for Vaccination 3
Participant is:
eligible per local/natio
nal recommendations a
nd confirmed to have rInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850776
Page 155 of 185
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eceived only placebo a
t Vaccination 1/2
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850777
Page 156 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-05-2021
12:26:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/5/2021Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850778
Page 157 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Mar-05-2021
12:26:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obt
ained
Mar/5/2021Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850779
Page 158 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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
Mar-05-2021
12:27:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/5/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-05-2021 12:27:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Mar-05-2021
12:27:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850780
Page 159 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-05-2021 13:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-05-2021 13:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-05-2021
13:45:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-05-2021
13:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Mar-05-2021
13:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/5/2021Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850781
Page 160 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a
Date Location User Value Reason
Mar-05-2021 13:45:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRGZ33Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-05-2021 13:45:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRGZ33Initial Entry
5.b
Date Location User Value Reason
Mar-05-2021 13:46:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRXW67Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-05-2021 13:46:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRXW67Initial Entry
5.c
Date Location User Value Reason
Mar-05-2021 13:47:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRXW65Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850782
Page 161 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.c Sample ID
Date Location User Value Reason
Mar-05-2021 13:47:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRXW65Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850783
Page 162 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-05-2021 16:37:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-05-2021 16:37:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-05-2021
16:38:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-05-2021
16:37:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Mar-05-2021
16:37:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/5/2021Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850784
Page 163 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a
Date Location User Value Reason
Mar-05-2021
16:38:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRGZ1DInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-05-2021
16:38:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRGZ1DInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850785
Page 164 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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
Mar-05-2021
12:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-05-2021 12:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-05-2021 12:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-05-2021
12:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/5/2021 10:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-05-2021 12:27:37
(UTC-03:00) City ofACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850786
Page 165 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires
6. Body Side:
Date Location User Value Reason
Mar-05-2021
12:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Mar-05-2021 12:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-05-2021 12:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-05-2021 12:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-05-2021 12:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850787
Page 166 of 185
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Mar-05-2021
12:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850788
Page 167 of 185
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-29-2021
09:38:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: Kindly
review and
complete ‘Nasal
Swab' form at
this visit. Thank
you.
Mar-25-2021
16:24:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/25/2021Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0850789
Page 168 of 185
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 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
Mar-25-2021 16:24:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-25-2021 16:24:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-25-2021 16:24:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-25-2021 16:24:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/25/2021 08:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-25-2021 16:24:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850790
Page 169 of 185
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
6. Body Side:
Date Location User Value Reason
Mar-25-2021 16:24:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Mar-25-2021 16:24:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-25-2021 16:24:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-25-2021 16:24:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-25-2021 16:24:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850791
Page 170 of 185
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Mar-25-2021 16:24:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850792
Page 171 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Jan-25-2021 15:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850793
Page 172 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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Mar-25-2021 16:26:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850794
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Jan-25-2021 15:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-25-2021 15:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Feb-08-2021
16:07:04
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Giselle
CastilloQuery
2: Clo
sedResponse
satisfies query
Feb-01-2021
16:42:09
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
2: An
swere
dThe FUP was
sent. The new
information is
that a
Pathological
Anatomy Report,
confirmed the
diagnosis of
acute ulcer-
phlenmonous
appendicitis.
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0850795
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Feb-01-2021
10:14:13
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Giselle
CastilloQuery
2: Op
enedCLINICAL_ Pls
provide
additional
information on
relevant test
performed during
hospital stay and
pathology report
after surgery in a
FU safety form.
Thank you.
Jan-26-2021
09:06:14
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has
been closed.
Jan-26-2021
07:37:49
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription
Error
Jan-26-2021
07:37:49
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
Appe
ndiciti
sTranscription
Error
Jan-25-2021
18:36:20
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedClarify
APENDICITIS
as
follows...Should
the spelling be
APPENDICITIS?
If so, edit.
Otherwise clarify.
Thank you.
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0850796
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Jan-25-2021
15:17:56
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
Apen
dicitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-25-2021 15:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/12/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-25-2021 15:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/21/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-25-2021 15:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial 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
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850797
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Jan-26-2021
12:59:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Deleted Query is invalid
or does not apply
Jan-26-2021
07:37:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Appendicitis:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Jan-25-2021
15:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Apendicitis:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Jan-25-2021
15:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?
NO
Did this serious event res
ult in death?
NO
Did this serious event re
quire or prolong hospital
ization?Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850798
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
YES
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
NO
Other medically importa
nt serious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-25-2021 15:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-25-2021 15:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is du
e to:
OTHERInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850799
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: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
If Other, specify:
Unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-25-2021 15:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-25-2021 15:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-25-2021 15:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-25-2021 15:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-25-2021 15:17:56
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850800
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, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-10-2021 05:50:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2021070160Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0850801
Page 180 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
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Mar-25-2021 16:26:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-25-2021 16:26:08
(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
Mar-25-2021 16:26:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
pain at the injection siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-25-2021 16:26:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/5/2021 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-25-2021 16:26:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850802
Page 181 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
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Mar/6/2021 UNK:UNK
6. Toxicity Grade:
Date Location User Value Reason
Mar-25-2021 16:26:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-25-2021 16:26:08
(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
Mar-25-2021 16:26:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-25-2021 16:26:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850803
Page 182 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
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-25-2021 16:26:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-25-2021 16:26:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-25-2021 16:26:08
(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
Mar-25-2021 16:26:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-25-2021 16:26:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (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-2021-5683-0850804
Page 183 of 185
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-25-2021 15:20:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/23/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-25-2021 15:20:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY F
OR ADDITIONAL VACCI
NATIONInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850805
Page 184 of 185
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-21-2020 14:48:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-28-2020 09:31:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZE
DInitial Entry
Aug-28-2020 09:24:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-21-2020 14:48:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
Aug-28-2020 09:31:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
Aug-28-2020 09:24:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850806
Page 185 of 185
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao
Clinica e Servicos Medicos Ltda
Subject No: 12261477 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-27-2020 15:31:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae4072\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850807