125742 S1 M5 CRF c4591001 1226 12261210

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

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Page 1 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848762
Page 2 of 307
***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: 12261210 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/17/2020
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848763
Page 3 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12261210]
2.Birth Date: /1990
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848764
Page 4 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848765
Page 5 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848766
Page 6 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848767
Page 7 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848768
Page 8 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848769
Page 9 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848770
Page 10 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848771
Page 11 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848772
Page 12 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[iron deficiency anemia]
Start Date: Jul/30/2020
Ongoing: YES
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848773
Page 13 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
2.Weight: [52.5]
3.Unit: kg
4.Height: [161.8]
5.Unit: cm
6.Body Mass Index: [20.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848774
Page 14 of 307
***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: 12261210 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/17/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848775
Page 15 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/17/2020
2.Randomization Number: [52152]
3.Randomization Group: [ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848776
Page 16 of 307
***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: 12261210 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/17/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLCJ0X]
5.bSample ID [BLCJ0W]
5.cSample ID [BP5GPW]
5.dSample ID [BP5GPV]
5.eSample ID [BP5GPT]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848777
Page 17 of 307
***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: 12261210 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/17/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5GNL]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848778
Page 18 of 307
***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: 12261210 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/17/2020 10:54
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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848779
Page 19 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848780
Page 20 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848781
Page 21 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848782
Page 22 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848783
Page 23 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848784
Page 24 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: FOREHEAD
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848785
Page 25 of 307
***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: 12261210 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/8/2020
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:
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848786
Page 26 of 307
***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: 12261210 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/8/2020
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 [BPWV6M]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848787
Page 27 of 307
***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: 12261210 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/8/2020 11:30
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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848788
Page 28 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848789
Page 29 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848790
Page 30 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848791
Page 31 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848792
Page 32 of 307
***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: 12261210 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/8/2020
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 [BPWZBN]
5.bSample ID [BRVBBW]
5.cSample ID [BRVBBV]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848793
Page 33 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848794
Page 34 of 307
***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: 12261210 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 [BRGZ5H]
5.bSample ID [BRXW9D]
5.cSample ID [BRXW9C]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848795
Page 35 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848796
Page 36 of 307
***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: 12261210 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 [ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848797
Page 37 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848798
Page 38 of 307
***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: 12261210 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 [ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848799
Page 39 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848800
Page 40 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/10/2020
2.Date of First Symptom
Started:Dec/6/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/8/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848801
Page 41 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Chest pain]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848802
Page 42 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848803
Page 43 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848804
Page 44 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[Sample was collected on site, recorded at swab pfe]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848805
Page 45 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 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:
Dec/10/2020
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 [BRGTFR]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848806
Page 46 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848807
Page 47 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848808
Page 48 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848809
Page 49 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848810
Page 50 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 1
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848811
Page 51 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848812
Page 52 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848813
Page 53 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848814
Page 54 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848815
Page 55 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848816
Page 56 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848817
Page 57 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Dec/10/2020 Record Identifier: Systolic: Diastolic:
1  99  64 Repeating Pages
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848818
Page 58 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [99]
Diastolic: [64]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in
beats/minute:[77]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848819
Page 59 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Dec/10/2020 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848820
Page 60 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/10/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848821
Page 61 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848822
Page 62 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848823
Page 63 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848824
Page 64 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848825
Page 65 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848826
Page 66 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848827
Page 67 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/28/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848828
Page 68 of 307
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
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: 12261210 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:
Jan/28/2021
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 [BRH0JM]
5.bSample ID [BSF40B]
5.cSample ID [BSF409]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848829
Page 69 of 307
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Aug/23/2020Form: 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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/23/2020
2.Erroneous Visit
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848830
Page 70 of 307
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Aug/23/2020Form: UNPLANNED VISIT
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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848831
Page 71 of 307
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Aug/23/2020Form: CONTACT OUTCOME - UNPLANNED
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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/23/2020
Contact Outcome:
VISIT NOT REQUIRED, DATA ENTRY ERROR IN
E-DIARY
3.Comments: [Telephone contact due to alert not to fill in the diary. Patient
claims she forgot to fill in but did not experience any
vaccination reaction these days]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848832
Page 72 of 307
***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: 12261210 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/8/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848833
Page 73 of 307
***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: 12261210 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: [ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848834
Page 74 of 307
***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: 12261210 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:
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848835
Page 75 of 307
***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: 12261210 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 [ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848836
Page 76 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848837
Page 77 of 307
***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: 12261210 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:
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848838
Page 78 of 307
***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: 12261210 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:
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848839
Page 79 of 307
***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: 12261210 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?
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848840
Page 80 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848841
Page 81 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848842
Page 82 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848843
Page 83 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848844
Page 84 of 307
***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: 12261210 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 [ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848845
Page 85 of 307
***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: 12261210 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 [ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848846
Page 86 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848847
Page 87 of 307
***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
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848848
Page 88 of 307
***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: 12261210 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.ADVERSE
EVENT 1  Exposure durin
g pregnancy Dec/10/2020
UNK:UNK YES  Repeating
Pages
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848849
Page 89 of 307
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 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)[Exposure during pregnancy]
4.Start Date Time: Dec/10/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848850
Page 90 of 307
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 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:NOT RELATED
If Not Related to study treatment(s), this event is
due to:
OTHER
If Other, specify:
[Pregnancy]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848851
Page 91 of 307
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:UNKNOWN
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848852
Page 92 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848853
Page 93 of 307
***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: 12261210 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[ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848854
Page 94 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848855
Page 95 of 307
***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: 12261210 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: //
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848856
Page 96 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848857
Page 97 of 307
***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: 12261210 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?
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848858
Page 98 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848859
Page 99 of 307
***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: 12261210 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?
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848860
Page 100 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848861
Page 101 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848862
Page 102 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848863
Page 103 of 307
***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: 12261210 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?
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848864
Page 104 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/28/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848865
Page 105 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848866
Page 106 of 307
***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: 12261210 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: [ ]
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848867
Page 107 of 307
***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: 12261210 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/8/2020
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848868
Page 108 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848869
Page 109 of 307
***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: 12261210 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-22-2021 15:38:13 (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.
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848870
Page 110 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-09-2020 10:03:25 (UTC-03:00)
City of Buenos Aires
FormAug-17-2020 14:37:16 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848871
Page 111 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormDec-11-2020 08:13:14 (UTC-03:00)
City of Buenos AiresNot Done
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848872
Page 112 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Dec-11-2020 08:13:14 (UTC-03:00)
City of Buenos AiresNot Done
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848873
Page 113 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Dec-11-2020 08:13:14 (UTC-03:00)
City of Buenos AiresNot Done
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848874
Page 114 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Dec-11-2020 08:13:14 (UTC-03:00)
City of Buenos AiresNot Done
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848875
Page 115 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Dec-11-2020 08:13:14 (UTC-03:00)
City of Buenos AiresNot Done
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848876
Page 116 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Dec-11-2020 08:13:14 (UTC-03:00)
City of Buenos AiresNot Done
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848877
Page 117 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Dec-11-2020 08:13:14 (UTC-03:00)
City of Buenos AiresNot Done
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848878
Page 118 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
7Dec-11-2020 08:13:14 (UTC-03:00)
City of Buenos AiresNot Done
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848879
Page 119 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
8Dec-11-2020 08:13:14 (UTC-03:00)
City of Buenos AiresNot Done
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848880
Page 120 of 307
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
9Dec-11-2020 08:13:14 (UTC-03:00)
City of Buenos AiresNot Done
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848881
Page 121 of 307
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Jan-19-2021 07:29:33 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848882
Page 122 of 307
***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: 12261210 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-22-2021 15:38:13 (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-22-2021 15:07:09 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Mar-15-2021 16:38:22 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848883
Page 123 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Mar-12-2021 16:46:40 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Feb-17-2021 08:24:33 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848884
Page 124 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-16-2021 05:43:44 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Feb-15-2021 08:37:07 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848885
Page 125 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-13-2021 11:33:25 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Feb-03-2021 18:09:43 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848886
Page 126 of 307
***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: 12261210 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-28-2021 17:41:59 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Jan-21-2021 16:06:44 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848887
Page 127 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Dec-11-2020 08:11:26 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Oct-21-2020 16:39:31 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848888
Page 128 of 307
***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: 12261210 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.
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848889
Page 129 of 307
***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: 12261210 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-17-2020
14:10:37
(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-17-2020
14:10:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848890
Page 130 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-17-2020
14:10:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Aug/17/2020Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848891
Page 131 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-17-2020
14:10:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12261210Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-17-2020
14:10:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1990Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-17-2020
14:11:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-17-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848892
Page 132 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
14:11:03
(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-17-2020
14:11:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848893
Page 133 of 307
***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: 12261210 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-17-2020
14:11:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848894
Page 134 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848895
Page 135 of 307
***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: 12261210 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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848896
Page 136 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.a Criterion met?
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n Nu
mbe
r:2Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848897
Page 137 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848898
Page 138 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Inclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848899
Page 139 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848900
Page 140 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN03A00
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848901
Page 141 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.c Inclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848902
Page 142 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848903
Page 143 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN04A00
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848904
Page 144 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.d Inclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848905
Page 145 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848906
Page 146 of 307
***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: 12261210 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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848907
Page 147 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.a Criterion met?
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:2Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848908
Page 148 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848909
Page 149 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.b Exclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848910
Page 150 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848911
Page 151 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX03A00
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848912
Page 152 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.c Exclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848913
Page 153 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848914
Page 154 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.d Exclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848915
Page 155 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.e
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848916
Page 156 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848917
Page 157 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.e Exclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848918
Page 158 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848919
Page 159 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848920
Page 160 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.f Exclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848921
Page 161 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848922
Page 162 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.g Exclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848923
Page 163 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.h
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848924
Page 164 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.h Exclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848925
Page 165 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.i
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848926
Page 166 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.i Exclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848927
Page 167 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848928
Page 168 of 307
***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: 12261210 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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848929
Page 169 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.j Exclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848930
Page 170 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848931
Page 171 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
2.k
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848932
Page 172 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.k Exclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848933
Page 173 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848934
Page 174 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX16A01
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848935
Page 175 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.l Exclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848936
Page 176 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-17-2020
14:24:05
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848937
Page 177 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX21A01
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848938
Page 178 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.m Exclusion Number:
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-17-2020
14:24:05
(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-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848939
Page 179 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-17-2020
14:24:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848940
Page 180 of 307
***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: 12261210 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-17-2020
14:36:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-17-2020
14:36:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-17-2020
14:36:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848941
Page 181 of 307
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Sep-09-2020
10:04:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:iron defici
ency ane
mia
Start Date
:Jul/30/202
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-09-2020
10:04:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020
10:04:01
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
iron deficiency anem
iaInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848942
Page 182 of 307
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
1.a Start Date:
Date Location User Value Reason
Sep-09-2020
10:04:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jul/30/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-09-2020
10:04:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848943
Page 183 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Aug-17-2020
14:37:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-17-2020
14:37:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
52.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-17-2020
14:37:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848944
Page 184 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-17-2020
14:37:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
161.8Initial Entry
5. Unit:
Date Location User Value Reason
Aug-17-2020
14:37:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-17-2020
14:37:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20.1Initial Entry
7.a
Date Location User Value Reason
Aug-17-2020
14:37:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Iden
tifier::1
Temperatur
e:36.5Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848945
Page 185 of 307
***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: 12261210 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-17-2020
14:37:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-17-2020
14:37:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-17-2020
14:37:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848946
Page 186 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-17-2020
14:37:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848947
Page 187 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-17-2020
14:38:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-17-2020
14:38:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-17-2020
14:38:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848948
Page 188 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-17-2020
14:38:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-17-2020
14:38:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-17-2020
14:38:38
(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:
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848949
Page 189 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-17-2020
14:38:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-17-2020
14:38:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-17-2020
14:38:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848950
Page 190 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-17-2020
14:38:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-17-2020
14:38:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
52152Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848951
Page 191 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-18-2020
11:41:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020
11:41:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-18-2020
11:42:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-18-2020
11:41:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848952
Page 192 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Aug-18-2020
11:41:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-18-2020
11:42:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLCJ0XInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-18-2020
11:42:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCJ0XInitial Entry
5.b
Date Location User Value Reason
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848953
Page 193 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-18-2020
11:42:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLCJ0
WInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-18-2020
11:42:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCJ0WInitial Entry
5.c
Date Location User Value Reason
Aug-18-2020
11:42:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP5GP
WInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-18-2020
11:42:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP5GPWInitial Entry
5.d
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848954
Page 194 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-18-2020
11:43:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP5GP
VInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-18-2020
11:43:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP5GPVInitial Entry
5.e
Date Location User Value Reason
Aug-18-2020
11:43:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP5GP
TInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-18-2020
11:43:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP5GPTInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848955
Page 195 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-18-2020
11:43:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020
11:43:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-18-2020
11:43:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-18-2020
11:43:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848956
Page 196 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Aug-18-2020
11:43:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-18-2020
11:43:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP5GN
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-18-2020
11:43:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP5GNLInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848957
Page 197 of 307
***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: 12261210 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-17-2020
14:39:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-17-2020
14:39:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-17-2020
14:39:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-17-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848958
Page 198 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
14:39:03
(UTC-03:00) City
of Buenos AiresAug/17/2020 10:54
5. Anatomical Location:
Date Location User Value Reason
Aug-17-2020
14:39:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-17-2020
14:39:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-17-2020
14:39:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848959
Page 199 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-17-2020
14:39:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-17-2020
14:39:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848960
Page 200 of 307
***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: 12261210 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-17-2020
14:39:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848961
Page 201 of 307
***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: 12261210 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-08-2020
15:13:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848962
Page 202 of 307
***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: 12261210 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-08-2020
15:13:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-08-2020
15:13:39
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848963
Page 203 of 307
***Confidential***
Sep-08-2020
15:13:39
(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-08-2020
15:13:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-08-2020
15:13:39
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848964
Page 204 of 307
***Confidential***
2.b Symptom:
Date Location User Value Reason
Sep-08-2020
15:13:39
(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-08-2020
15:13:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-08-2020
15:13:39
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848965
Page 205 of 307
***Confidential***
2.c Symptom:
Date Location User Value Reason
Sep-08-2020
15:13:39
(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-08-2020
15:13:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-08-2020
15:13:39
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848966
Page 206 of 307
***Confidential***
2.d Symptom:
Date Location User Value Reason
Sep-08-2020
15:13:39
(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-08-2020
15:13:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-08-2020
15:13:39
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848967
Page 207 of 307
***Confidential***
2.e Symptom:
Date Location User Value Reason
Sep-08-2020
15:13:39
(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-08-2020
15:13:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-08-2020
15:13:39
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848968
Page 208 of 307
***Confidential***
2.f Symptom:
Date Location User Value Reason
Sep-08-2020
15:13:39
(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-08-2020
15:13:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-08-2020
15:13:39
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848969
Page 209 of 307
***Confidential***
2.g Symptom:
Date Location User Value Reason
Sep-08-2020
15:13:39
(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
Sep-08-2020
15:13:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-08-2020
15:13:39
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848970
Page 210 of 307
***Confidential***
2.h Symptom:
Date Location User Value Reason
Sep-08-2020
15:13:39
(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
Sep-08-2020
15:13:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-08-2020
15:13:39
(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-08-2020
15:13:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-08-2020
15:13:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::RE
D
N
ESInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848971
Page 211 of 307
***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
Sep-08-2020
15:13:39
(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-08-2020
15:13:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-08-2020
15:13:39
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848972
Page 212 of 307
***Confidential***
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-08-2020
15:13:39
(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-08-2020
15:13:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-08-2020
15:13:39
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848973
Page 213 of 307
***Confidential***
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-08-2020
15:13:39
(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-08-2020
15:13:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848974
Page 214 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020
15:13:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020
15:13:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.3
Temperatur
e Unit:C
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020
15:13:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848975
Page 215 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.a Temperature:
Date Location User Value Reason
Sep-08-2020
15:13:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-08-2020
15:13:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-08-2020
15:13:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0848976
Page 216 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-08-2020
15:14:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-08-2020
15:14:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-08-2020
15:14:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848977
Page 217 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-08-2020
15:14:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-08-2020
15:14:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-08-2020
15:14:06
(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:
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848978
Page 218 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-08-2020
15:14:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-08-2020
15:14:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-08-2020
15:14:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848979
Page 219 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020
15:32:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020
15:32:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020
15:33:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-08-2020
15:32:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0848980
Page 220 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Sep-08-2020
15:32:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020
15:33:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPWV6
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-08-2020
15:33:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPWV6MInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848981
Page 221 of 307
***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: 12261210 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-08-2020
15:16:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020
15:16:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020
15:16:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-08-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848982
Page 222 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
15:16:34
(UTC-03:00) City
of Buenos AiresSep/8/2020 11:30
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020
15:16:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-08-2020
15:16:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-08-2020
15:16:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848983
Page 223 of 307
***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: 12261210 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-08-2020
15:16:34
(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-08-2020
15:16:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0848984
Page 224 of 307
***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: 12261210 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-09-2020
14:16:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848985
Page 225 of 307
***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: 12261210 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-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
2.a Symptom:
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0848986
Page 226 of 307
***Confidential***
Date Location User Value Reason
Oct-09-2020
14:16:17
(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-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-09-2020
14:16:17
(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
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848987
Page 227 of 307
***Confidential***
2.b Symptom:
Date Location User Value Reason
Oct-09-2020
14:16:17
(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-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: HE
A
D
AC
HE
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:N
OInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848988
Page 228 of 307
***Confidential***
2.c Symptom:
Date Location User Value Reason
Oct-09-2020
14:16:17
(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-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848989
Page 229 of 307
***Confidential***
2.d Symptom:
Date Location User Value Reason
Oct-09-2020
14:16:17
(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-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:NOInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848990
Page 230 of 307
***Confidential***
2.e Symptom:
Date Location User Value Reason
Oct-09-2020
14:16:17
(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-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: DI
A
RR
HE
A
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was complet
ed?:N
OInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848991
Page 231 of 307
***Confidential***
2.f Symptom:
Date Location User Value Reason
Oct-09-2020
14:16:17
(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-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NOInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848992
Page 232 of 307
***Confidential***
2.g Symptom:
Date Location User Value Reason
Oct-09-2020
14:16:17
(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-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR
WOR
SENE
D JOI
NT P
AIN
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NOInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848993
Page 233 of 307
***Confidential***
2.h Symptom:
Date Location User Value Reason
Oct-09-2020
14:16:17
(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-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-09-2020
14:16:17
(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-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::RE
D
N
ESInitial Entry
090177e196ae404b\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0848994
Page 234 of 307
***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-09-2020
14:16:17
(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-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-09-2020
14:16:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data En
…[truncated]