125742 S1 M5 CRF c4591001 1226 12261190

Document text

Page 1 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848542
Page 2 of 220
***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: 12261190 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/14/2020
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848543
Page 3 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12261190]
2.Birth Date: /1980
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848544
Page 4 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/14/2020
2.Erroneous Visit
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848545
Page 5 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848546
Page 6 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848547
Page 7 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848548
Page 8 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848549
Page 9 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848550
Page 10 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848551
Page 11 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848552
Page 12 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848553
Page 13 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Aug/14/2020
2.Weight: [63.1]
3.Unit: kg
4.Height: [160.7]
5.Unit: cm
6.Body Mass Index: [24.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848554
Page 14 of 220
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/14/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848555
Page 15 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/14/2020
2.Randomization Number: [50014]
3.Randomization Group: [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848556
Page 16 of 220
***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: 12261190 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/14/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5GL4]
5.bSample ID [BP5GL3]
5.cSample ID [BP5GL2]
5.dSample ID [BLCHZK]
5.eSample ID [BLCHZJ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848557
Page 17 of 220
***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: 12261190 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/14/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5GM4]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848558
Page 18 of 220
***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: 12261190 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/14/2020 11:53
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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848559
Page 19 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848560
Page 20 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848561
Page 21 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848562
Page 22 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848563
Page 23 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848564
Page 24 of 220
***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: 12261190 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: [36.8]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848565
Page 25 of 220
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/4/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848566
Page 26 of 220
***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: 12261190 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 [BP9DY0]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848567
Page 27 of 220
***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: 12261190 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 14:18
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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848568
Page 28 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848569
Page 29 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848570
Page 30 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848571
Page 31 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848572
Page 32 of 220
***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: 12261190 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 [BPVYTK]
5.bSample ID [BLC0R0]
5.cSample ID [BLC0R1]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848573
Page 33 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848574
Page 34 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/12/2021
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 [BRGZ5J]
5.bSample ID [BRXW9G]
5.cSample ID [BRXW9F]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848575
Page 35 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848576
Page 36 of 220
***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: 12261190 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 [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848577
Page 37 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848578
Page 38 of 220
***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: 12261190 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 [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848579
Page 39 of 220
***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: 12261190 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:
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848580
Page 40 of 220
***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: 12261190 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: [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848581
Page 41 of 220
***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: 12261190 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 [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848582
Page 42 of 220
***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: 12261190 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 [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848583
Page 43 of 220
***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: 12261190 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?
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848584
Page 44 of 220
***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: 12261190 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:
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848585
Page 45 of 220
***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: 12261190 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:
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848586
Page 46 of 220
***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: 12261190 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 [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848587
Page 47 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848588
Page 48 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848589
Page 49 of 220
***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: 12261190 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: [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848590
Page 50 of 220
***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: 12261190 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: [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848591
Page 51 of 220
***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: 12261190 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:
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848592
Page 52 of 220
***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: 12261190 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 [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848593
Page 53 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848594
Page 54 of 220
***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: 12261190 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:
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848595
Page 55 of 220
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848596
Page 56 of 220
***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: 12261190 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?
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848597
Page 57 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848598
Page 58 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848599
Page 59 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848600
Page 60 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848601
Page 61 of 220
***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: 12261190 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 [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848602
Page 62 of 220
***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: 12261190 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 [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848603
Page 63 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/23/2021
2.Erroneous Visit
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848604
Page 64 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848605
Page 65 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERS
E EVENT 1  left axillary lymph
node enlargement Sep/6/2020
UNK:UNK NO
End Date Time:
Dec/UNK/2020
UNK:UNK
 Repeating
Pages
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848606
Page 66 of 220
***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: 12261190 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)[left axillary lymph node enlargement]
4.Start Date Time: Sep/6/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/UNK/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848607
Page 67 of 220
***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: 12261190 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).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848608
Page 68 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848609
Page 69 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848610
Page 70 of 220
***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: 12261190 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[ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848611
Page 71 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848612
Page 72 of 220
***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: 12261190 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: //
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848613
Page 73 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848614
Page 74 of 220
***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: 12261190 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?
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848615
Page 75 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848616
Page 76 of 220
***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: 12261190 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?
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848617
Page 77 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848618
Page 78 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848619
Page 79 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848620
Page 80 of 220
***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: 12261190 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?
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848621
Page 81 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/23/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848622
Page 82 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848623
Page 83 of 220
***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: 12261190 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: [ ]
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848624
Page 84 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848625
Page 85 of 220
***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: 12261190 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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848626
Page 86 of 220
***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: 12261190 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-15-2021 16:38:01 (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.
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848627
Page 87 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormAug-14-2020 14:32:22 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848628
Page 88 of 220
***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: 12261190 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-15-2021 16:38:01 (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-12-2021 14:02:33 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Feb-10-2021 17:47:05 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848629
Page 89 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-25-2021 11:04:16 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Oct-10-2020 11:14:58 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848630
Page 90 of 220
***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: 12261190 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.
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848631
Page 91 of 220
***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: 12261190 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-14-2020
14:31:16
(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-14-2020
14:31:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848632
Page 92 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-14-2020
14:31:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Aug/14/2020Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848633
Page 93 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-14-2020
14:31:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12261190Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-14-2020
14:31:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1980Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-14-2020
14:31:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-14-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848634
Page 94 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
14:31:28
(UTC-03:00) City
of Buenos AiresHISPANIC OR LATI
NO(A) OR OF SPAN
ISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-14-2020
14:31:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848635
Page 95 of 220
***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: 12261190 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-14-2020
14:31:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848636
Page 96 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:1
Crit
erio
n D
escr
iptio
n:Male or female
participants bet
ween the ages o
f 18 and 55 yea
rs, inclusive, 65
and 85 years, in
clusive, or 18 a
nd 85 years, inc
lusive, at rando
mization (depen
dent upon study
stage)
Crit
erio
n m
et?:YESInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848637
Page 97 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female partici
pants between the age
s of 18 and 55 years, i
nclusive, 65 and 85 ye
ars, inclusive, or 18 a
nd 85 years, inclusive,
at randomization (dep
endent upon study sta
ge)Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848638
Page 98 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.a Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(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-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n Nu
mbe
r:2Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848639
Page 99 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n De
scri
ptio
n:Participants wh
o are willing an
d able to compl
y with all sched
uled visits, vac
cination plan, l
aboratory tests,
lifestyle consid
erations, and ot
her study proce
dures
Crit
erio
n me
t?:YES
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN02A00
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848640
Page 100 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Inclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are
willing and able to co
mply with all schedul
ed visits, vaccination
plan, laboratory tests,
lifestyle consideration
s, and other study pro
ceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848641
Page 101 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:Healthy partici
pants who are d
etermined by m
edical history, p
hysical examin
ation, and clini
cal judgment of
the investigator
to be eligible fo
r inclusion in th
e study
Crit
erio
n m
et?:YESInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848642
Page 102 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN03A00
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848643
Page 103 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.c Inclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants
who are determined b
y medical history, phy
sical examination, and
clinical judgment of t
he investigator to be e
ligible for inclusion in
the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848644
Page 104 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n Nu
mbe
r:4
Crit
erio
n De
scri
ptio
n:Capable of givi
ng personal sig
ned informed c
onsent, which i
ncludes compli
ance with the r
equirements an
d restrictions li
sted in the ICD
and in this prot
ocol
Crit
erio
n me
t?:YESInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848645
Page 105 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN04A00
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848646
Page 106 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.d Inclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving per
sonal signed informed
consent, which includ
es compliance with th
e requirements and res
trictions listed in the I
CD and in this protoc
olInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848647
Page 107 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:1
Crit
erio
n De
scri
ptio
n:Other medical
or psychiatric c
ondition incl. re
cent (within pas
t year) or active
suicidal ideatio
n/behavior/lab
abnormality tha
t may increase t
he risk of study
participation
Crit
erio
n m
et?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848648
Page 108 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psyc
hiatric condition incl.
recent (within past ye
ar) or active suicidal i
deation/behavior/lab a
bnormality that may i
ncrease the risk of stu
dy participationInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848649
Page 109 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.a Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(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-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:2Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848650
Page 110 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crite
rion
Descr
iptio
n:Known infecti
on with huma
n immunodefi
ciency virus (
HIV), hepatiti
s C virus (HC
V), or hepatiti
s B virus (HB
V)
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX02A00
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848651
Page 111 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.b Exclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection with
human immunodeficie
ncy virus (HIV), hepa
titis C virus (HCV), or
hepatitis B virus (HB
V)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848652
Page 112 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:3
Crit
erio
n De
scrip
tion:History of seve
re adverse react
ion associated
with a vaccine
and/or severe a
llergic reaction
(eg, anaphylaxi
s) to any comp
onent of the stu
dy intervention
(s)
Crit
erio
n me
t?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848653
Page 113 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX03A00
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848654
Page 114 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.c Exclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adve
rse reaction associated
with a vaccine and/or
severe allergic reactio
n (eg, anaphylaxis) to
any component of the
study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848655
Page 115 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:4
Criterio
n Descri
ption:Receipt of
medications
intended to
prevent CO
VID-19
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX04A00Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848656
Page 116 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.d Exclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medication
s intended to prevent
COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(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-14-2020
14:31:59
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848657
Page 117 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.e
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:8
Crit
erio
n De
scrip
tion:Immunocompr
omised individ
uals with know
n or suspected
immunodeficie
ncy, as determi
ned by history
and/or laborato
ry/physical exa
mination
Crit
erio
n me
t?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848658
Page 118 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX08A00
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848659
Page 119 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.e Exclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised
individuals with know
n or suspected immun
odeficiency, as determ
ined by history and/or
laboratory/physical ex
aminationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848660
Page 120 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:10
Crit
erio
n De
scrip
tion:Bleeding diath
esis or conditio
n associated wi
th prolonged bl
eeding that wo
uld, in the opin
ion of the inves
tigator, contrai
ndicate intramu
scular injection
Crit
erio
n me
t?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848661
Page 121 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX10A00
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848662
Page 122 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.f Exclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or
condition associated
with prolonged bleedi
ng that would, in the o
pinion of the investiga
tor, contraindicate intr
amuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848663
Page 123 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numbe
r:11
Criterio
n Descri
ption:Women w
ho are pre
gnant or br
eastfeedin
g
Criterio
n met?:NO
Criterio
n ID: (Fo
r Pfizer
use only)
:EX11A00Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848664
Page 124 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.g Exclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are preg
nant or breastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(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-14-2020
14:31:59
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848665
Page 125 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.h
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:12
Criterio
n Descri
ption:Previous va
ccination w
ith any cor
onavirus va
ccine
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX12A00Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848666
Page 126 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.h Exclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccination
with any coronavirus
vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(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-14-2020
14:31:59
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848667
Page 127 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.i
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:13
Crite
rion
Descr
iption
:Subjects who
receive immu
nosuppressive
therapy, such
as cytotoxic a
gents or syste
mic corticoste
roids
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX13A01Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848668
Page 128 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.i Exclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive i
mmunosuppressive th
erapy, such as cytotox
ic agents or systemic
corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848669
Page 129 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:15
Crit
erio
n De
scrip
tion:Receipt of bloo
d/plasma produ
cts or immuno
globulin, from
60 days before
study interventi
on administrati
on or planned r
eceipt througho
ut the study
Crit
erio
n me
t?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848670
Page 130 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX14A01
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848671
Page 131 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.j Exclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plas
ma products or immu
noglobulin, from 60 d
ays before study inter
vention administration
or planned receipt thr
oughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848672
Page 132 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848673
Page 133 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
2.k
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:16
Crite
rion
Desc
ripti
on:Participation i
n other studies
involving stud
y intervention
within 28 days
prior to study
entry and/or d
uring study pa
rticipation
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX15A01Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848674
Page 134 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.k Exclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other
studies involving stud
y intervention within
28 days prior to study
entry and/or during st
udy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848675
Page 135 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:17
Crite
rion
Descr
iption
:Previous parti
cipation in ot
her studies in
volving study
intervention c
ontaining lipi
d nanoparticl
es
Crite
rion
met?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848676
Page 136 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX16A01
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848677
Page 137 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.l Exclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participation
in other studies invol
ving study interventio
n containing lipid nan
oparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848678
Page 138 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:22
Crit
erio
n D
escr
iptio
n:Investigator sit
e staff or Pfizer
employees dire
ctly involved in
the conduct of t
he study, site st
aff otherwise s
upervised by th
e investigator,
and their respe
ctive family me
mbers
Crit
erio
n m
et?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848679
Page 139 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX21A01
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848680
Page 140 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.m Exclusion Number:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff
or Pfizer employees d
irectly involved in the
conduct of the study,
site staff otherwise su
pervised by the invest
igator, and their respe
ctive family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848681
Page 141 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-14-2020
14:31:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848682
Page 142 of 220
***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: 12261190 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-14-2020
14:32:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-14-2020
14:32:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-14-2020
14:32:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848683
Page 143 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Aug-14-2020
14:32:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-14-2020
14:32:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
63.1Initial Entry
3. Unit:
Date Location User Value Reason
Aug-14-2020
14:32:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848684
Page 144 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-14-2020
14:32:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
160.7Initial Entry
5. Unit:
Date Location User Value Reason
Aug-14-2020
14:32:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-14-2020
14:32:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24.4Initial Entry
7.a
Date Location User Value Reason
Aug-14-2020
14:32:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Iden
tifier::1
Temperatur
e:36.7Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848685
Page 145 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Temperatur
e Unit:C
Temperatur
e Location::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Aug-14-2020
14:32:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-14-2020
14:32:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-14-2020
14:32:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848686
Page 146 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-14-2020
14:32:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848687
Page 147 of 220
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-14-2020
14:32:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-14-2020
14:32:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-14-2020
14:32:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848688
Page 148 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-14-2020
14:32:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-14-2020
14:32:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-14-2020
14:32:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848689
Page 149 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-14-2020
14:32:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-14-2020
14:32:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-14-2020
14:32:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848690
Page 150 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-14-2020
14:33:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-14-2020
14:33:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
50014Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848691
Page 151 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020
16:34:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020
16:34:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020
16:34:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-14-2020
16:34:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848692
Page 152 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Aug-14-2020
16:34:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020
16:34:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP5GL4Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-14-2020
16:34:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP5GL4Initial Entry
5.b
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848693
Page 153 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-14-2020
16:34:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP5GL3Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-14-2020
16:34:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP5GL3Initial Entry
5.c
Date Location User Value Reason
Aug-14-2020
16:34:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP5GL2Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-14-2020
16:34:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP5GL2Initial Entry
5.d
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848694
Page 154 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-14-2020
16:34:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLCHZ
KInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-14-2020
16:34:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCHZKInitial Entry
5.e
Date Location User Value Reason
Aug-14-2020
16:34:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLCHZ
JInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-14-2020
16:34:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCHZJInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848695
Page 155 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020
16:34:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020
16:34:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020
16:34:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-14-2020
16:34:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848696
Page 156 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Aug-14-2020
16:34:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020
16:34:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP5GM
4Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-14-2020
16:34:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP5GM4Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848697
Page 157 of 220
***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: 12261190 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-14-2020
14:33:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-14-2020
14:33:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-14-2020
14:33:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-14-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848698
Page 158 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
14:33:18
(UTC-03:00) City
of Buenos AiresAug/14/2020 11:53
5. Anatomical Location:
Date Location User Value Reason
Aug-14-2020
14:33:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-14-2020
14:33:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-14-2020
14:33:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848699
Page 159 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-14-2020
14:33:18
(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-14-2020
14:33:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848700
Page 160 of 220
***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: 12261190 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-14-2020
14:33:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848701
Page 161 of 220
***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: 12261190 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-04-2020
15:57:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848702
Page 162 of 220
***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: 12261190 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-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848703
Page 163 of 220
***Confidential***
Sep-04-2020
15:58:18
(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-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848704
Page 164 of 220
***Confidential***
2.b Symptom:
Date Location User Value Reason
Sep-04-2020
15:58:18
(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-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848705
Page 165 of 220
***Confidential***
2.c Symptom:
Date Location User Value Reason
Sep-04-2020
15:58:18
(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-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
LS
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848706
Page 166 of 220
***Confidential***
2.d Symptom:
Date Location User Value Reason
Sep-04-2020
15:58:18
(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-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848707
Page 167 of 220
***Confidential***
2.e Symptom:
Date Location User Value Reason
Sep-04-2020
15:58:18
(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-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848708
Page 168 of 220
***Confidential***
2.f Symptom:
Date Location User Value Reason
Sep-04-2020
15:58:18
(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-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-04-2020
15:58:18
(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 la
st day the Su
bject Diary
was complet
ed?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0848709
Page 169 of 220
***Confidential***
2.g Symptom:
Date Location User Value Reason
Sep-04-2020
15:58:18
(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-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848710
Page 170 of 220
***Confidential***
2.h Symptom:
Date Location User Value Reason
Sep-04-2020
15:58:18
(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-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-04-2020
15:58:18
(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-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::RE
D
NE
SSInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848711
Page 171 of 220
***Confidential***
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:N
O
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020
15:58:18
(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-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection
site reactions pr
esent on the last
day the Subject
Diary was com
pleted?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848712
Page 172 of 220
***Confidential***
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020
15:58:18
(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-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITE
Were injectio
n site reaction
s present on t
he last day the
Subject Diary
was complete
d?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848713
Page 173 of 220
***Confidential***
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020
15:58:18
(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
Sep-04-2020
15:58:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848714
Page 174 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020
15:58:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2.a
Date Location User Value Reason
Sep-04-2020
15:58:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Iden
tifier::1
Temperatur
e:36.8
Temperatur
e Unit:C
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-04-2020
15:58:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848715
Page 175 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.a Temperature:
Date Location User Value Reason
Sep-04-2020
15:58:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-04-2020
15:58:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-04-2020
15:58:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848716
Page 176 of 220
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-04-2020
15:58:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-04-2020
15:58:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-04-2020
15:58:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848717
Page 177 of 220
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-04-2020
15:58:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-04-2020
15:58:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-04-2020
15:58:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848718
Page 178 of 220
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-04-2020
15:58:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-04-2020
15:58:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-04-2020
15:58:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848719
Page 179 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020
16:20:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
16:20:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020
16:21:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-04-2020
16:20:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848720
Page 180 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Sep-04-2020
16:20:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020
16:21:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP9DY
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020
16:21:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP9DY0Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848721
Page 181 of 220
***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: 12261190 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
15:59:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020
15:59:04
(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
15:59:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-04-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848722
Page 182 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
15:59:04
(UTC-03:00) City
of Buenos AiresSep/4/2020 14:18
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020
15:59:04
(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
15:59:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020
15:59:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848723
Page 183 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-04-2020
15:59:04
(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
Sep-04-2020
15:59:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848724
Page 184 of 220
***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: 12261190 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
10:08:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848725
Page 185 of 220
***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: 12261190 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
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-03-2020
10:10:02
(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 S
ubject Diary wa
s completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848726
Page 186 of 220
***Confidential***
Oct-03-2020
10:10:02
(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
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-03-2020
10:10:02
(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
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848727
Page 187 of 220
***Confidential***
2.b Symptom:
Date Location User Value Reason
Oct-03-2020
10:10:02
(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
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: HE
A
D
AC
HE
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848728
Page 188 of 220
***Confidential***
2.c Symptom:
Date Location User Value Reason
Oct-03-2020
10:10:02
(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
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-03-2020
10:10:02
(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 w
as completed?:N
OInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848729
Page 189 of 220
***Confidential***
2.d Symptom:
Date Location User Value Reason
Oct-03-2020
10:10:02
(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
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848730
Page 190 of 220
***Confidential***
2.e Symptom:
Date Location User Value Reason
Oct-03-2020
10:10:02
(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
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: DI
A
RR
HE
A
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848731
Page 191 of 220
***Confidential***
2.f Symptom:
Date Location User Value Reason
Oct-03-2020
10:10:02
(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
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-03-2020
10:10:02
(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 com
pleted?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848732
Page 192 of 220
***Confidential***
2.g Symptom:
Date Location User Value Reason
Oct-03-2020
10:10:02
(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
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
N
Were fever o
r systemic sy
mptoms pre
sent on the l
ast day the S
ubject Diary
was complet
ed?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848733
Page 193 of 220
***Confidential***
2.h Symptom:
Date Location User Value Reason
Oct-03-2020
10:10:02
(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
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-03-2020
10:10:02
(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
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::RE
D
N
ESInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848734
Page 194 of 220
***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
10:10:02
(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
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848735
Page 195 of 220
***Confidential***
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-03-2020
10:10:02
(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
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-03-2020
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site
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 Di
ary was com
pleted?:NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848736
Page 196 of 220
***Confidential***
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-03-2020
10:10:02
(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
10:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848737
Page 197 of 220
***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: 12261190 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
11:31:38
(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
11:31:38
(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
11:31:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-03-2020
11:31:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848738
Page 198 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Oct-03-2020
11:31:38
(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
11:31:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPVYT
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-03-2020
11:31:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPVYTKInitial Entry
5.b
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848739
Page 199 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-03-2020
11:31:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLC0R
0Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-03-2020
11:31:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLC0R0Initial Entry
5.c
Date Location User Value Reason
Oct-03-2020
11:32:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLC0R
1Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-03-2020
11:32:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLC0R1Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848740
Page 200 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021
14:02:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/12/2021Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848741
Page 201 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021
16:19:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
16:19:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
16:19:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
16:19:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848742
Page 202 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Mar-12-2021
16:19:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Mar/12/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021
16:19:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRGZ5
JInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021
16:19:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRGZ5JInitial Entry
5.b
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848743
Page 203 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Mar-12-2021
16:19:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRXW9
GInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-12-2021
16:19:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRXW9GInitial Entry
5.c
Date Location User Value Reason
Mar-12-2021
16:19:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRXW9
FInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-12-2021
16:19:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRXW9FInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848744
Page 204 of 220
***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: 12261190 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-05-2020
16:56:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-05-2020
16:56:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-05-2020
16:56:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848745
Page 205 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-26-2021
10:56:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/23/2021Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848746
Page 206 of 220
***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: 12261190 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
Jan-26-2021
10:56:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-26-2021
10:56:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-26-2021
10:56:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible and N
OT confirmed tInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848747
Page 207 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
o have received
only placebo at
Vaccination 1/2
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848748
Page 208 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Sep-12-2020
14:01:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848749
Page 209 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Sep-12-2020
14:01:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-12-2020
14:01:10
(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
Jan-25-2021
16:08:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Jan-25-2021
11:04:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Answered Data updated.
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848750
Page 210 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Jan-22-2021
11:44:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Opened Clinquery:
Could you
confirm if the
AE is still
on-going?
Oct-20-2020
13:03:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-19-2020
15:08:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Answered The possible
relation
between the
vacine and the
event is due to
2 motives: a)
the event
developed on
the same arm
side the
subject
received the
injection; b)
the event
happened 2
days after the
injection,
occurring,
ttherefore, a
temporal
relationship
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848751
Page 211 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-15-2020
17:05:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened Clinquery:
why do you
say the lymph
node
enlargement is
related to
vaccine
Sep-12-2020
14:01:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
left axillary lymph
node enlargementInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-12-2020
14:01:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/6/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-25-2021
11:04:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/UNK/2020
UNK:UNKNew
Information
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848752
Page 212 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Jan-08-2021
10:37:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Dec-18-2020
14:34:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Answere
dThe PI tried to
make a
telephone
contact with
the subject on
18DEC2020,
but had no
answer. He
will keep
trying and as
soon as he get
the
information,
we will
atualize.
Dec-14-2020
08:48:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Juleen Gayed Query 2: Opened Clin: Please
confirm if this
AE is still
ongoing
Nov-09-2020
15:27:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-09-2020
11:56:25ACV0PFEINFP6000  Query 1: Answere
dThe PI made a
telephone
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0848753
Page 213 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City
of Buenos Airescontact on
09NOV2020
with the
subject that
reported that
the AE is still
ongoing.
Nov-06-2020
11:09:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened GPD Clinical:
please clarify
if this AE is
still Ongoing,
thank you.
Sep-12-2020
14:01:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-12-2020
14:01:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848754
Page 214 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
Sep-12-2020
14:01:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-12-2020
14:01:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-12-2020
14:01:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848755
Page 215 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-12-2020
14:01:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-12-2020
14:01:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-12-2020
14:01:10
(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
Jan-25-2021
11:05:12
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Clo
sedClose Auto Query
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848756
Page 216 of 220
***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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Jan-25-2021
11:05:12
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
RECOVERE
D/RESOLVE
DNew Information
Jan-25-2021
11:04:16
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Ope
nedFor AE left axillary
lymph node
enlargement: Response
to "What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Sep-12-2020
14:01:10
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
RECOVERI
NG/RESOLV
INGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-12-2020
14:01:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848757
Page 217 of 220
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-26-2021
10:56:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/23/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-26-2021
10:56:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848758
Page 218 of 220
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-05-2020
16:56:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-14-2020
14:33:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-14-2020
14:32:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-05-2020
16:56:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/2/2020Initial Entry
Aug-14-2020
14:33:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848759
Page 219 of 220
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-14-2020
14:32:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848760
Page 220 of 220
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail 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: 12261190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-10-2020
08:19:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae4060\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848761