125742 S1 M5 CRF c4591001 1226 12261136

Document text

Page 1 of 226
***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: 12261136 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
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847996
Page 2 of 226
***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: 12261136 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/12/2020
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847997
Page 3 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12261136]
2.Birth Date: 1970
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0847998
Page 4 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/12/2020
2.Erroneous Visit
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847999
Page 5 of 226
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 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
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848000
Page 6 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history,
physical examination, and clinical judgment of the investigator
to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which
includes compliance with the requirements and restrictions
listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past
year) or active suicidal ideation/behavior/lab abnormality that
may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX01A00
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848001
Page 7 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine
and/or severe allergic reaction (eg, anaphylaxis) to any
component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX04A00
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848002
Page 8 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848003
Page 9 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 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
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848004
Page 10 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention
within 28 days prior to study entry and/or during study
participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study
intervention containing lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in
the conduct of the study, site staff otherwise supervised by the
investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX21A01
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848005
Page 11 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848006
Page 12 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hemorrhoids]
Start Date: Feb/UNK/2001
Ongoing: NO
End Date:
Jan/26/2021
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848007
Page 13 of 226
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Aug/12/2020
2.Weight: [86.0]
3.Unit: kg
4.Height: [172.5]
5.Unit: cm
6.Body Mass Index: [28.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848008
Page 14 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/12/2020
2.Randomization Number: [47109]
3.Randomization Group: [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848009
Page 15 of 226
***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: 12261136 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/12/2020
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 [BP5HG7]
5.bSample ID [BP5HG6]
5.cSample ID [BP5HG5]
5.dSample ID [BLCTHZ]
5.eSample ID [BLCTHY]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848010
Page 16 of 226
***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: 12261136 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/12/2020
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 [BP5HC7]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848011
Page 17 of 226
***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: 12261136 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/12/2020 12:18
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
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848012
Page 18 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848013
Page 19 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848014
Page 20 of 226
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848015
Page 21 of 226
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848016
Page 22 of 226
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848017
Page 23 of 226
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: FOREHEAD
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848018
Page 24 of 226
***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: 12261136 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/4/2020
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 [BP9DX0]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848019
Page 25 of 226
***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: 12261136 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/4/2020 12:49
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
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848020
Page 26 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848021
Page 27 of 226
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848022
Page 28 of 226
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848023
Page 29 of 226
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848024
Page 30 of 226
***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: 12261136 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/2/2020
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 [BPVYSF]
5.bSample ID [BLC0PG]
5.cSample ID [BLC0PH]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848025
Page 31 of 226
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848026
Page 32 of 226
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 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:
Feb/26/2021
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 [BR612X]
5.bSample ID [BSCX1D]
5.cSample ID [BSCX1F]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848027
Page 33 of 226
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848028
Page 34 of 226
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 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 [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848029
Page 35 of 226
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848030
Page 36 of 226
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 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 [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848031
Page 37 of 226
***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: 12261136 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:
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848032
Page 38 of 226
***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: 12261136 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: [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848033
Page 39 of 226
***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: 12261136 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 [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848034
Page 40 of 226
***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: 12261136 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 [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848035
Page 41 of 226
***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: 12261136 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?
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848036
Page 42 of 226
***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: 12261136 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:
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848037
Page 43 of 226
***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: 12261136 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:
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848038
Page 44 of 226
***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: 12261136 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 [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848039
Page 45 of 226
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848040
Page 46 of 226
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848041
Page 47 of 226
***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: 12261136 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/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848042
Page 48 of 226
***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: 12261136 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: [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848043
Page 49 of 226
***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: 12261136 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:
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848044
Page 50 of 226
***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: 12261136 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 [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848045
Page 51 of 226
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848046
Page 52 of 226
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12261136 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:
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848047
Page 53 of 226
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12261136 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?
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848048
Page 54 of 226
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848049
Page 55 of 226
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848050
Page 56 of 226
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848051
Page 57 of 226
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848052
Page 58 of 226
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 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 [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848053
Page 59 of 226
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 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 [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848054
Page 60 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848055
Page 61 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848056
Page 62 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Hemorrhoid
Worsening Jan/26/2021
UNK:UNK NO
End Date Time:
Jan/27/2021 UNK:
UNK
 Repeating
Pages
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848057
Page 63 of 226
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 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)[Hemorrhoid Worsening]
4.Start Date Time: Jan/26/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/27/2021 UNK:UNK
6.Toxicity Grade: 4
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848058
Page 64 of 226
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Hemorrhoids]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848059
Page 65 of 226
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021215389]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848060
Page 66 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848061
Page 67 of 226
***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: 12261136 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[ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848062
Page 68 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848063
Page 69 of 226
***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: 12261136 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: //
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848064
Page 70 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848065
Page 71 of 226
***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: 12261136 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?
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848066
Page 72 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848067
Page 73 of 226
***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: 12261136 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?
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848068
Page 74 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848069
Page 75 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848070
Page 76 of 226
***Confidential***
 
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848071
Page 77 of 226
***Confidential***
 
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848072
Page 78 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/28/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848073
Page 79 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848074
Page 80 of 226
***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: 12261136 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: [ ]
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848075
Page 81 of 226
***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: 12261136 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/2/2020
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848076
Page 82 of 226
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 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
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848077
Page 83 of 226
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Cristiano
Zerbini Approved Mar-05-2021 15:39:05 (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.
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848078
Page 84 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormMar-03-2021 08:14:42 (UTC-03:00)
City of Buenos Aires
FormAug-12-2020 16:59:40
(UTC-03:00) City of Buenos AiresNot Applicable
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848079
Page 85 of 226
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Cristiano
Zerbini Approved Mar-05-2021 15:39:05 (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 12:00:06 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Mar-05-2021 11:00:54 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848080
Page 86 of 226
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 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 09:34:53 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Mar-03-2021 09:00:11 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848081
Page 87 of 226
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 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-02-2021 16:54:51 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Mar-01-2021 10:02:13 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848082
Page 88 of 226
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-26-2021 14:15:54 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Feb-10-2021 17:40:37 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848083
Page 89 of 226
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-03-2021 15:35:19 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Oct-10-2020 07:55:39 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848084
Page 90 of 226
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 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 Oct-03-2020 07:58:40 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Sep-14-2020 16:55:18 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848085
Page 91 of 226
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 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.
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848086
Page 92 of 226
***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: 12261136 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-12-2020
16:56:39
(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-12-2020
16:56:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848087
Page 93 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-12-2020
16:56:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Aug/12/2020Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848088
Page 94 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-12-2020
16:56:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12261136Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-12-2020
16:56:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1970Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-12-2020
16:57:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-12-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848089
Page 95 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
16:57:03
(UTC-03:00) City
of Buenos AiresHISPANIC OR LAT
INO(A) OR OF SP
ANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-12-2020
16:57:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848090
Page 96 of 226
***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: 12261136 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-12-2020
16:57:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848091
Page 97 of 226
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:1
Crit
erio
n D
escr
ipti
on:Male or femal
e participants
between the a
ges of 18 and
55 years, inclu
sive, 65 and 8
5 years, inclus
ive, or 18 and
85 years, inclu
sive, at rando
mization (dep
endent upon st
udy stage)
Crit
erio
n m
et?:YESInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848092
Page 98 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female parti
cipants between the
ages of 18 and 55 ye
ars, inclusive, 65 an
d 85 years, inclusive
, or 18 and 85 years,
inclusive, at random
ization (dependent uInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848093
Page 99 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
pon study stage)
1.a Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(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-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:2Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848094
Page 100 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n D
escr
iptio
n:Participants w
ho are willing
and able to co
mply with all
scheduled visi
ts, vaccinatio
n plan, labora
tory tests, life
style consider
ations, and ot
her study proc
edures
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN02A00
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848095
Page 101 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Inclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are
willing and able to c
omply with all sche
duled visits, vaccina
tion plan, laboratory
tests, lifestyle consi
derations, and other
study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848096
Page 102 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:3
Crit
erio
n D
escr
ipti
on:Healthy partic
ipants who ar
e determined
by medical hi
story, physica
l examination,
and clinical ju
dgment of the
investigator to
be eligible for
inclusion in th
e studyInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848097
Page 103 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (F
or P
fize
r us
e on
ly):IN03A00
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848098
Page 104 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.c Inclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants
who are determined
by medical history,
physical examinatio
n, and clinical judg
ment of the investig
ator to be eligible fo
r inclusion in the stu
dyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848099
Page 105 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:4
Crit
erio
n D
escr
iptio
n:Capable of gi
ving personal
signed inform
ed consent, w
hich includes
compliance w
ith the require
ments and res
trictions listed
in the ICD an
d in this proto
colInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848100
Page 106 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN04A00
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848101
Page 107 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.d Inclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving p
ersonal signed infor
med consent, which
includes compliance
with the requiremen
ts and restrictions lis
ted in the ICD and i
n this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848102
Page 108 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
um
ber:1
Crit
erio
n D
escr
ipti
on:Other medical
or psychiatric
condition incl.
recent (within
past year) or a
ctive suicidal
ideation/beha
vior/lab abnor
mality that ma
y increase the
risk of study p
articipationInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848103
Page 109 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n m
et?:NO
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or ps
ychiatric condition i
ncl. recent (within p
ast year) or active suInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848104
Page 110 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
icidal ideation/beha
vior/lab abnormality
that may increase th
e risk of study partic
ipation
2.a Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(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-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:2Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848105
Page 111 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crite
rion
Desc
ripti
on:Known infec
tion with hu
man immuno
deficiency vi
rus (HIV), he
patitis C viru
s (HCV), or
hepatitis B vi
rus (HBV)
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX02A00
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848106
Page 112 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.b Exclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection wit
h human immunode
ficiency virus (HIV)
, hepatitis C virus (
HCV), or hepatitis
B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848107
Page 113 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:History of sev
ere adverse re
action associa
ted with a vac
cine and/or se
vere allergic r
eaction (eg, a
naphylaxis) to
any compone
nt of the stud
y intervention
(s)
Crit
erio
n m
et?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848108
Page 114 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX03A00
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848109
Page 115 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.c Exclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe ad
verse reaction associ
ated with a vaccine
and/or severe allergi
c reaction (eg, anap
hylaxis) to any com
ponent of the study i
ntervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848110
Page 116 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:4
Criteri
on Des
criptio
n:Receipt of
medicatio
ns intende
d to preve
nt COVID
-19
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX04A00Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848111
Page 117 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.d Exclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medicati
ons intended to prev
ent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(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-12-2020
16:58:04
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848112
Page 118 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.e
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:8
Crit
erio
n De
scri
ptio
n:Immunocomp
romised indiv
iduals with k
nown or susp
ected immun
odeficiency, a
s determined
by history an
d/or laborator
y/physical ex
amination
Crit
erio
n m
et?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848113
Page 119 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX08A00
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848114
Page 120 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.e Exclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromis
ed individuals with
known or suspected
immunodeficiency,
as determined by his
tory and/or laborator
y/physical examinati
onInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848115
Page 121 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:10
Crit
erio
n De
scri
ptio
n:Bleeding diat
hesis or condi
tion associate
d with prolon
ged bleeding t
hat would, in
the opinion of
the investigat
or, contraindi
cate intramus
cular injectio
nInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848116
Page 122 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n m
et?:NO
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX10A00
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848117
Page 123 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.f Exclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis o
r condition associate
d with prolonged ble
eding that would, in
the opinion of the in
vestigator, contraind
icate intramuscular i
njectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848118
Page 124 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:11
Criterio
n Descri
ption:Women
who are p
regnant o
r breastfe
eding
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX11A00Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848119
Page 125 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.g Exclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are pre
gnant or breastfeedi
ngInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(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-12-2020
16:58:04
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848120
Page 126 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.h
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:12
Criteri
on Desc
ription:Previous v
accination
with any c
oronavirus
vaccine
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX12A00Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848121
Page 127 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.h Exclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccinatio
n with any coronavir
us vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(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-12-2020
16:58:04
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848122
Page 128 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.i
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:13
Crite
rion
Desc
riptio
n:Subjects wh
o receive im
munosuppre
ssive therapy
, such as cyt
otoxic agent
s or systemic
corticosteroi
ds
Crite
rion
met?
:NO
Crite
rion
ID: (
For P
fizer
use o
nly):EX13A01Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848123
Page 129 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.i Exclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receiv
e immunosuppressiv
e therapy, such as cy
totoxic agents or sys
temic corticosteroid
sInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848124
Page 130 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:15
Crit
erio
n De
scri
ptio
n:Receipt of blo
od/plasma pr
oducts or im
munoglobulin
, from 60 day
s before study
intervention a
dministration
or planned re
ceipt through
out the study
Crit
erio
n m
et?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848125
Page 131 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX14A01
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848126
Page 132 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.j Exclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/pla
sma products or im
munoglobulin, from
60 days before study
intervention adminis
tration or planned re
ceipt throughout the
studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848127
Page 133 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848128
Page 134 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
2.k
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:16
Crit
erio
n De
scrip
tion:Participation
in other studi
es involving
study interve
ntion within
28 days prior
to study entr
y and/or duri
ng study part
icipation
Crit
erio
n me
t?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848129
Page 135 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX15A01
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848130
Page 136 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.k Exclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in othe
r studies involving s
tudy intervention wi
thin 28 days prior to
study entry and/or d
uring study particip
ationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848131
Page 137 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:17
Crite
rion
Descr
iptio
n:Previous par
ticipation in
other studie
s involving
study interv
ention conta
ining lipid n
anoparticles
Crite
rion
met?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848132
Page 138 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX16A01
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848133
Page 139 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.l Exclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participati
on in other studies i
nvolving study inter
vention containing l
ipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848134
Page 140 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exc
lusi
on
Nu
mbe
r:22
Crit
erio
n D
escr
ipti
on:Investigator s
ite staff or Pfi
zer employee
s directly inv
olved in the c
onduct of the
study, site staf
f otherwise su
pervised by th
e investigator,
and their resp
ective family
membersInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848135
Page 141 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n m
et?:NO
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:EX21A01
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848136
Page 142 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.m Exclusion Number:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staf
f or Pfizer employe
es directly involved
in the conduct of th
e study, site staff ot
herwise supervised
by the investigator,
and their respective
family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848137
Page 143 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020
16:58:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848138
Page 144 of 226
***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: 12261136 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-12-2020
16:58:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-12-2020
16:58:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-12-2020
16:58:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848139
Page 145 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Mar-03-2021
08:18:47
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Line/MH
Number:1
Medical
History
Term:Hemorr
hoids
Start Dat
e:Feb/UN
K/2001
Ongoing: NO
End D
ate:
Jan/
26/2
021Transcription
Error
Mar-03-2021
08:16:12
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical
History
Term:Hemorr
hoids
Start Dat
e:Feb/UN
K/2020Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848140
Page 146 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Ongoing: NO
End D
ate:
Jan/
26/2
021
1.a Line/MH Number:
Date Location User Value Reason
Mar-03-2021
08:16:12
(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
Mar-03-2021
08:16:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
HemorrhoidsInitial Entry
1.a Start Date:
Date Location User Value Reason
Mar-03-2021
08:18:47
(UTC-03:00)ACV0PFEINFP6000  Data Entry:
Feb/UNK/2001Transcription
Error
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848141
Page 147 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
City of Buenos
Aires
Mar-03-2021
08:16:12
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Feb/UNK/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Mar-03-2021
08:16:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/26/2021Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848142
Page 148 of 226
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Aug-12-2020
17:00:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-12-2020
17:00:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
86.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-12-2020
17:00:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848143
Page 149 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-12-2020
17:00:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
172.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-12-2020
17:00:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-12-2020
17:00:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.9Initial Entry
7.a
Date Location User Value Reason
Aug-12-2020
17:00:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.5Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848144
Page 150 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Temperatu
re Unit:C
Temperatu
re Location
::FORE
HEA
D
7.a Record Identifier:
Date Location User Value Reason
Aug-12-2020
17:00:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-12-2020
17:00:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-12-2020
17:00:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848145
Page 151 of 226
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7.a Temperature Location:
Date Location User Value Reason
Aug-12-2020
17:00:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848146
Page 152 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-12-2020
17:01:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-12-2020
17:01:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
47109Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848147
Page 153 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020
17:16:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020
17:16:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020
17:16:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-12-2020
17:16:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848148
Page 154 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Aug-12-2020
17:16:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Aug-14-2020
17:25:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Katherine
LiauQuery 1: Closed Response
satisfies query
Aug-14-2020
10:18:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Answered Changed data
per query
Aug-14-2020
06:38:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Katherine
LiauQuery 1: Opened GPD CLIN:
Please confirm if
all sample IDs
are provided for
blood draw for
immunogenicity
as only 3 of the
expected 5
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0848149
Page 155 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
sample
IDs/aliquots are
reported. Please
provide
comment for
reason or update
all sample IDs as
applicable.
5.a
Date Location User Value Reason
Aug-12-2020
17:16:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP5HG
7Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-12-2020
17:16:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP5HG7Initial Entry
5.b
Date Location User Value Reason
Aug-12-2020
17:17:05ACV0PFEINFP6000  Data Entry:
Sample ID BP5HGInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848150
Page 156 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City
of Buenos Aires: 6
5.b Sample ID
Date Location User Value Reason
Aug-12-2020
17:17:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP5HG6Initial Entry
5.c
Date Location User Value Reason
Aug-12-2020
17:17:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP5HG
5Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-12-2020
17:17:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP5HG5Initial Entry
5.d
Date Location User Value Reason
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848151
Page 157 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-14-2020
10:18:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLCTH
ZInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-14-2020
10:18:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCTHZInitial Entry
5.e
Date Location User Value Reason
Aug-14-2020
10:18:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLCTH
YInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-14-2020
10:18:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCTHYInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848152
Page 158 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020
17:17:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020
17:17:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020
17:17:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-12-2020
17:17:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848153
Page 159 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Aug-12-2020
17:17:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-12-2020
17:17:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP5HC
7Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-12-2020
17:17:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP5HC7Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848154
Page 160 of 226
***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: 12261136 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-12-2020
17:02:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-12-2020
17:02:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-12-2020
17:02:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-12-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848155
Page 161 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
17:02:36
(UTC-03:00) City
of Buenos AiresAug/12/2020 12:18
5. Anatomical Location:
Date Location User Value Reason
Aug-12-2020
17:02:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-12-2020
17:02:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-12-2020
17:02:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848156
Page 162 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-12-2020
17:02:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-12-2020
17:02:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848157
Page 163 of 226
***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: 12261136 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-12-2020
17:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES - REACTOGE
NICITY E-DIARY
COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848158
Page 164 of 226
***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: 12261136 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-03-2020
09:07:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848159
Page 165 of 226
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848160
Page 166 of 226
***Confidential***
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848161
Page 167 of 226
***Confidential***
2.b Symptom:
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848162
Page 168 of 226
***Confidential***
2.c Symptom:
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
LS
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848163
Page 169 of 226
***Confidential***
2.d Symptom:
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848164
Page 170 of 226
***Confidential***
2.e Symptom:
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848165
Page 171 of 226
***Confidential***
2.f Symptom:
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
IN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848166
Page 172 of 226
***Confidential***
2.g Symptom:
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848167
Page 173 of 226
***Confidential***
2.h Symptom:
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site Re
action::RE
D
NE
SSInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848168
Page 174 of 226
***Confidential***
Were injection si
te reactions pres
ent on the last da
y the Subject Dia
ry was complete
d?:N
O
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848169
Page 175 of 226
***Confidential***
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTIO
N SI
TE
Were injection
site reactions
present on the
last day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848170
Page 176 of 226
***Confidential***
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
09:17:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848171
Page 177 of 226
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020
06:46:53
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Sep-04-2020
16:19:23
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answere
ddue to the
temperature
variation of
the vaccine (2
September),
vital signs
were evaluated
only on 4
September
Sep-04-2020
16:18:45
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Vital signs
Date
04/Sep/2020 is
not same as
Date of Visit
02/Sep/2020.
Please review
and update as
appropriate or
clarify.
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848172
Page 178 of 226
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-04-2020
16:18:45
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020New
Information
Sep-03-2020
09:19:28
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2.a
Date Location User Value Reason
Sep-04-2020
16:19:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperat
ure:36.2
Temperat
ure Unit:C
Temperat
ure Locati
on::FORE
HEA
DNew
Information
Sep-03-2020
09:19:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperat
ure:36.3Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848173
Page 179 of 226
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Temperat
ure Unit:C
Temperat
ure Locati
on::FORE
HEA
D
2.a Record Identifier:
Date Location User Value Reason
Sep-03-2020
09:19:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-04-2020
16:19:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.2New
Information
Sep-03-2020
09:19:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-03-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0848174
Page 180 of 226
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
09:19:28
(UTC-03:00) City
of Buenos AiresC
2.a Temperature Location:
Date Location User Value Reason
Sep-03-2020
09:19:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848175
Page 181 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-05-2020
07:33:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-05-2020
07:33:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020
06:47:13
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Sep-05-2020
07:34:08
(UTC-03:00)ACV0PFEINFP6000  Query 1: Answere
dThere was a
temperature
instability on
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848176
Page 182 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
City of Buenos
Airesthe vaccines
freezers that
lead to a delay
in the
vaccination, so
due to that, the
visit and the
vaccination
occurred on
different dates.
Sep-05-2020
07:33:53
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Sep-05-2020
07:33:27
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-05-2020
07:33:27
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of
Collection
04/Sep/2020 is
greater than
Date of Visit
02/Sep/2020.
Please review
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848177
Page 183 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
and update as
appropriate,
else clarify.
Sep-05-2020
07:33:27
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-05-2020
07:33:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP9DX
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-05-2020
07:33:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP9DX0Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848178
Page 184 of 226
***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: 12261136 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-04-2020
16:21:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020
16:21:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020
16:21:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-09-2020 ACV0PFEINFP6000  Query 1: Closed Response
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848179
Page 185 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
06:48:04
(UTC-03:00)
City of Buenos
Airessatisfies query
Sep-04-2020
16:22:01
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answere
ddue to the
temperature
variation of the
vaccine
(September 2),
patient recivied
2nd dose only
on September 4
Sep-04-2020
16:21:03
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Dose Date is
not equal to
Date of Visit
02/Sep/2020 of
the
corresponding
Visit. Please
review and
update as
appropriate.
Sep-04-2020
16:21:03
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020 12:49Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848180
Page 186 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-04-2020
16:21:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-04-2020
16:21:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020
16:21:03
(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-04-2020
16:21:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848181
Page 187 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-04-2020
16:21:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848182
Page 188 of 226
***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: 12261136 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-03-2020
07:58:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848183
Page 189 of 226
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
2.a Symptom:
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848184
Page 190 of 226
***Confidential***
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848185
Page 191 of 226
***Confidential***
2.b Symptom:
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: HE
A
D
AC
HE
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:N
OInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848186
Page 192 of 226
***Confidential***
2.c Symptom:
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848187
Page 193 of 226
***Confidential***
2.d Symptom:
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848188
Page 194 of 226
***Confidential***
2.e Symptom:
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: DI
A
RR
HE
A
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was complet
ed?:N
OInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848189
Page 195 of 226
***Confidential***
2.f Symptom:
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848190
Page 196 of 226
***Confidential***
2.g Symptom:
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR
WOR
SENE
D JOI
NT P
AIN
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848191
Page 197 of 226
***Confidential***
2.h Symptom:
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::RE
D
N
ESInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848192
Page 198 of 226
***Confidential***
S
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:N
O
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions
present on the
last day the Su
bject Diary w
as completed?
:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848193
Page 199 of 226
***Confidential***
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Sit
e Reaction::PAI
N A
T IN
JEC
TIO
N SI
TE
Were injectio
n site reactio
ns present on
the last day t
he Subject D
iary was com
pleted?:NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848194
Page 200 of 226
***Confidential***
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-03-2020
07:58:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848195
Page 201 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-03-2020
11:23:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-03-2020
11:23:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-03-2020
11:23:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-03-2020
11:23:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848196
Page 202 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Oct-03-2020
11:23:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-03-2020
11:23:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPVYS
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-03-2020
11:23:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPVYSFInitial Entry
5.b
Date Location User Value Reason
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848197
Page 203 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-03-2020
11:23:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLC0P
GInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-03-2020
11:23:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLC0PGInitial Entry
5.c
Date Location User Value Reason
Oct-03-2020
11:23:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLC0P
HInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-03-2020
11:23:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLC0PHInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848198
Page 204 of 226
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021
14:15:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/26/2021Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848199
Page 205 of 226
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-27-2021
09:40:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-27-2021
09:40:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-27-2021
09:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-27-2021
09:40:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848200
Page 206 of 226
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Feb-27-2021
09:40:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Feb/26/2021Initial Entry
5.a
Date Location User Value Reason
Feb-27-2021
09:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BR612
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-27-2021
09:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR612XInitial Entry
5.b
Date Location User Value Reason
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848201
Page 207 of 226
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Feb-27-2021
09:41:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BSCX1
DInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-27-2021
09:41:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BSCX1DInitial Entry
5.c
Date Location User Value Reason
Feb-27-2021
09:41:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BSCX1
FInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-27-2021
09:41:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BSCX1FInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848202
Page 208 of 226
***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: 12261136 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-03-2020
07:59:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-03-2020
07:59:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-03-2020
07:59:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848203
Page 209 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021
15:35:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848204
Page 210 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-03-2021
15:35:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing
to return for Vaccina
tion 3
Participant is:
eligible and NOT
confirmed to hav
e received only p
lacebo at Vaccina
tion 1/2Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848205
Page 211 of 226
***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: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Feb-26-2021
14:18:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848206
Page 212 of 226
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Feb-26-2021
14:18:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-26-2021
14:18:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-12-2021
12:36:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Clos
edSDB updated
Mar-08-2021
19:47:36
(UTC-03:00)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Clos
edResponse satisfies
query
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0848207
Page 213 of 226
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
City of Buenos
Aires
Mar-08-2021
13:46:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Reis
sued:Candida
tePending SDB update
Mar-08-2021
09:12:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Ans
weredA FUP was already
sent on 05MAR2021
Mar-08-2021
07:32:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Ope
nedSAE RECON:
AER#2021215389,the
term was reported as
'anal bleeding' in
Safety database while
recorded as
'Hemorrhoid
Worsening' in AE
CRF. Please confirm
correct term.If safety
update is required,
please submit a
follow-up form.
Mar-05-2021
12:01:19
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Data Entry:
Hemorrhoid
WorseningTranscription Error
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848208
Page 214 of 226
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aires
Mar-05-2021
12:00:06
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Worsening of
hhemorrhoidsChanged Information
Mar-05-2021
10:55:34
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Ans
weredIndication for surgery
was the Anal bleeding
itself. Hemorrhoid
was grade 4,
according to
investigator (already
removed in
hemorrhoidectomy).
Mar-05-2021
08:11:21
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Ope
nedMedical Monitor_ Pls
advise: 1]indication
for surgery,
2]Hemorrhoid
grading. Thanks
Feb-26-2021
14:18:43
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Anal bleedingInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848209
Page 215 of 226
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Feb-26-2021
14:18:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/26/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-02-2021
16:54:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/27/2021 UN
K:UNKfollow-up
02Mar2021
Feb-26-2021
14:18:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/26/2021 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-26-2021
14:18:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848210
Page 216 of 226
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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-01-2021
07:36:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-26-2021
14:18:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Anal
bleeding:
Response to
"Is the
adverse event
serious?" is
'Yes' but
"Serious
Adverse
Event
Number" is
blank.
Feb-26-2021
14:18:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious eve
nt associated with
congenital anomalInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848211
Page 217 of 226
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
y or birth defect?
NO
Did this serious ev
ent result in death?
NO
Did this serious ev
ent require or prol
ong hospitalizatio
n?
YES
Did this serious ev
ent result in persist
ent or significant d
isability/incapacit
y?
NO
Is this serious eve
nt life threatening?
NO
Other medically i
mportant serious e
vent
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848212
Page 218 of 226
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
Feb-26-2021
14:18:43
(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-08-2021
19:48:43
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response
satisfies query
Mar-05-2021
12:00:32
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answered Updated
accordingly
Mar-05-2021
08:11:43
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened V10 section
8.50.2.3. If the
event of
hemorrhoid is
an intermittent
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0848213
Page 219 of 226
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
AE (as
reported on
Med Hx) the
new episodes
should be
recorded as
“worsening
of…”. Please
update event
term
accordingly.
Feb-26-2021
14:18:43
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to
study treatment(s)
, this event is due
to:
OTHER
If Other, specif
y:
HemorrhoidsInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-26-2021
14:18:43
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848214
Page 220 of 226
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-26-2021
14:18:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-08-2021
19:49:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response
satisfies query
Mar-05-2021
09:34:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
ddata entry
correction
Mar-05-2021
09:34:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESdata entry
correction
Mar-05-2021
08:07:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Medical
monitor_ Per
report, subject
underwent
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0848215
Page 221 of 226
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
surgery. Please
revise and
update this
form
accordingly.
Thanks
Feb-26-2021
14:18:43
(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
Feb-26-2021
14:18:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-26-2021
14:18:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848216
Page 222 of 226
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261136 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Mar-01-2021
07:36:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2021215389Initial Entry
090177e196ae404d\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683
…[truncated]