Document text
Page 1 of 236
***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: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850808
Page 2 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/5/2020
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850809
Page 3 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12261545]
2.Birth Date: 1979
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850810
Page 4 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/5/2020
2.Erroneous Visit
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850811
Page 5 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850812
Page 6 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850813
Page 7 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850814
Page 8 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850815
Page 9 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850816
Page 10 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850817
Page 11 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850818
Page 12 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850819
Page 13 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/5/2020
2.Weight: [51.9]
3.Unit: kg
4.Height: [163.0]
5.Unit: cm
6.Body Mass Index: [19.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850820
Page 14 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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/5/2020
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:
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850821
Page 15 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/5/2020
2.Randomization Number: [82687]
3.Randomization Group: [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850822
Page 16 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/5/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTJLB]
5.bSample ID [BPTJL9]
5.cSample ID [BPTJL8]
5.dSample ID [BPHNTY]
5.eSample ID [BPHNTX]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850823
Page 17 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/5/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTJK4]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850824
Page 18 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/5/2020 12:04
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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850825
Page 19 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850826
Page 20 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850827
Page 21 of 236
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850828
Page 22 of 236
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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/24/2020
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:
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850829
Page 23 of 236
***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: 12261545 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/24/2020
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 [BP7X8W]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850830
Page 24 of 236
***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: 12261545 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/24/2020 09:06
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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850831
Page 25 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850832
Page 26 of 236
***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: 12261545 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/22/2020
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 [BR6NN1]
5.bSample ID [BS8580]
5.cSample ID [BS8581]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850833
Page 27 of 236
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/23/2021
2.Erroneous Visit
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850834
Page 28 of 236
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: 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: 12261545 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/23/2021
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 [BRGDPV]
5.bSample ID [BSCX6H]
5.cSample ID [BSCX6J]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850835
Page 29 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850836
Page 30 of 236
***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: 12261545 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 [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850837
Page 31 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850838
Page 32 of 236
***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: 12261545 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 [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850839
Page 33 of 236
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850840
Page 34 of 236
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850841
Page 35 of 236
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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 [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850842
Page 36 of 236
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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 [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850843
Page 37 of 236
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850844
Page 38 of 236
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850845
Page 39 of 236
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850846
Page 40 of 236
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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 [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850847
Page 41 of 236
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850848
Page 42 of 236
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850849
Page 43 of 236
***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: 12261545 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/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850850
Page 44 of 236
***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: 12261545 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: [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850851
Page 45 of 236
***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: 12261545 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:
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850852
Page 46 of 236
***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: 12261545 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 [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850853
Page 47 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850854
Page 48 of 236
***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: 12261545 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:
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850855
Page 49 of 236
***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: 12261545 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:
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850856
Page 50 of 236
***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: 12261545 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?
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850857
Page 51 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850858
Page 52 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850859
Page 53 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850860
Page 54 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850861
Page 55 of 236
***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: 12261545 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 [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850862
Page 56 of 236
***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: 12261545 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 [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850863
Page 57 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850864
Page 58 of 236
***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: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850865
Page 59 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERS
E EVENT
1 headache Sep/5/2020
17:00 NO
End Date Time:
Sep/7/2020 UN
K:UNK
Repeating
Pages
2.ADVERS
E EVENT
2 Pain at injection sit
e Sep/5/2020
17:00 NO
End Date Time:
Sep/7/2020 UN
K:UNK
Repeating
Pages
3.ADVERS
E EVENT
3 headache Sep/24/2020
19:00 NO
End Date Time:
Sep/24/2020 UN
K:UNK
Repeating
Pages
4.ADVERS
E EVENT
4 muscle pain Sep/24/2020
19:00 NO
End Date Time:
Sep/25/2020 UN
K:UNK
Repeating
Pages
5.ADVERS
E EVENT
5 enlargement of left
axillary lymph node
Sep/25/2020
UNK:UNK NO
End Date Time:Repeating
Pages
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850866
Page 60 of 236
***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: 12261545 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
Oct/28/2020 UN
K:UNK
6.ADVERS
E EVENT
6 Body pain Sep/26/2020
UNK:UNK NO
End Date Time:
Sep/26/2020 UN
K:UNK
Repeating
Pages
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850867
Page 61 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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)[headache]
4.Start Date Time: Sep/5/2020 17:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/7/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850868
Page 62 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850869
Page 63 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850870
Page 64 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Pain at injection site]
4.Start Date Time: Sep/5/2020 17:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/7/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850871
Page 65 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850872
Page 66 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850873
Page 67 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[headache]
4.Start Date Time: Sep/24/2020 19:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/24/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850874
Page 68 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850875
Page 69 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850876
Page 70 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[muscle pain]
4.Start Date Time: Sep/24/2020 19:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/25/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850877
Page 71 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850878
Page 72 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850879
Page 73 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[enlargement of left axillary lymph node]
4.Start Date Time: Sep/25/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/28/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850880
Page 74 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850881
Page 75 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850882
Page 76 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Body pain]
4.Start Date Time: Sep/26/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/26/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850883
Page 77 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850884
Page 78 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850885
Page 79 of 236
***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: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850886
Page 80 of 236
***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: 12261545 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[ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850887
Page 81 of 236
***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: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850888
Page 82 of 236
***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: 12261545 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: //
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850889
Page 83 of 236
***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: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850890
Page 84 of 236
***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: 12261545 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?
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850891
Page 85 of 236
***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: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850892
Page 86 of 236
***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: 12261545 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?
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850893
Page 87 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850894
Page 88 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850895
Page 89 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850896
Page 90 of 236
***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: 12261545 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?
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850897
Page 91 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/22/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850898
Page 92 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850899
Page 93 of 236
***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: 12261545 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: [ ]
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850900
Page 94 of 236
***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: 12261545 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/22/2020
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850901
Page 95 of 236
***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: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850902
Page 96 of 236
***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: 12261545 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-24-2021 11:16:34 (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.
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850903
Page 97 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-07-2020 09:09:35 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0850904
Page 98 of 236
***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: 12261545 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-24-2021 11:16:34 (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-23-2021 11:13:35 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Feb-05-2021 10:13:24 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850905
Page 99 of 236
***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: 12261545 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-01-2021 09:11:19 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Nov-10-2020 17:21:02 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850906
Page 100 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Nov-09-2020 12:33:27 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Oct-27-2020 15:53:51 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850907
Page 101 of 236
***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: 12261545 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.
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850908
Page 102 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-07-2020
09:08:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-07-2020
09:08:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850909
Page 103 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-07-2020
09:08:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consen
t Obtained
Sep/5/2020Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850910
Page 104 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-07-2020
09:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12261545Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-07-2020
09:07:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1979Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-07-2020
09:08:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-07-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0850911
Page 105 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
09:08:24
(UTC-03:00) City
of Buenos AiresHISPANIC OR LATI
NO(A) OR OF SPANI
SH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-07-2020
09:08:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850912
Page 106 of 236
***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: 12261545 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-07-2020
09:08:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/5/2020Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850913
Page 107 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850914
Page 108 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(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 an
d 85 years, inclusive,
at randomization (dep
endent upon study sta
ge)Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850915
Page 109 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.a Criterion met?
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Incl
usio
n Nu
mbe
r:2Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850916
Page 110 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850917
Page 111 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Inclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850918
Page 112 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850919
Page 113 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN03A00
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850920
Page 114 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.c Inclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants w
ho are determined by
medical history, physi
cal examination, and c
linical judgment of th
e investigator to be eli
gible for inclusion in t
he studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850921
Page 115 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850922
Page 116 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN04A00
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850923
Page 117 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.d Inclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850924
Page 118 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850925
Page 119 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850926
Page 120 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.a Criterion met?
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion
Num
ber:2Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850927
Page 121 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850928
Page 122 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.b Exclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with
human immunodeficie
ncy virus (HIV), hepat
itis C virus (HCV), or
hepatitis B virus (HB
V)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850929
Page 123 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850930
Page 124 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX03A00
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850931
Page 125 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.c Exclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850932
Page 126 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850933
Page 127 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.d Exclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850934
Page 128 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.e
Date Location User Value Reason
Sep-07-2020
09:09:00
(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 i
mmunodeficie
ncy, as determi
ned by history
and/or laborato
ry/physical exa
mination
Crit
erio
n me
t?:NOInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850935
Page 129 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850936
Page 130 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.e Exclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850937
Page 131 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850938
Page 132 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850939
Page 133 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.f Exclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850940
Page 134 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850941
Page 135 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.g Exclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are pregn
ant or breastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850942
Page 136 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.h
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850943
Page 137 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.h Exclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850944
Page 138 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
2.i
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850945
Page 139 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.i Exclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive i
mmunosuppressive th
erapy, such as cytotox
ic agents or systemic c
orticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850946
Page 140 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Sep-07-2020
09:09:00
(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 immunog
lobulin, from 6
0 days before s
tudy interventi
on administrati
on or planned r
eceipt througho
ut the study
Crit
erio
n me
t?:NOInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850947
Page 141 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850948
Page 142 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.j Exclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850949
Page 143 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850950
Page 144 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
2.k
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850951
Page 145 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.k Exclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850952
Page 146 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850953
Page 147 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX16A01
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850954
Page 148 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.l Exclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850955
Page 149 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850956
Page 150 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX21A01
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850957
Page 151 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.m Exclusion Number:
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Sep-07-2020
09:09:00
(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
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850958
Page 152 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-07-2020
09:09:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850959
Page 153 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-07-2020
09:09:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-07-2020
09:09:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-07-2020
09:09:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850960
Page 154 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-07-2020
09:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/5/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-07-2020
09:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
51.9Initial Entry
3. Unit:
Date Location User Value Reason
Sep-07-2020
09:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850961
Page 155 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
09:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
163.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-07-2020
09:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-07-2020
09:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19.5Initial Entry
7.a
Date Location User Value Reason
Sep-07-2020
09:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Iden
tifier::1
Temperatur
e:36.4Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850962
Page 156 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 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
Sep-07-2020
09:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-07-2020
09:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-07-2020
09:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850963
Page 157 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-07-2020
09:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850964
Page 158 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-07-2020
09:11:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-07-2020
09:11:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-07-2020
09:11:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/5/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850965
Page 159 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
09:11:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-07-2020
09:11:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-07-2020
09:11:06
(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:
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850966
Page 160 of 236
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-07-2020
09:11:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-07-2020
09:11:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-07-2020
09:11:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850967
Page 161 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-07-2020
09:11:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/5/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-07-2020
09:11:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
82687Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850968
Page 162 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020
11:33:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020
11:33:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020
11:33:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-07-2020
11:33:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850969
Page 163 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Sep-07-2020
11:33:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/5/2020Initial Entry
5.a
Date Location User Value Reason
Sep-07-2020
11:33:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BPTJL
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-07-2020
11:33:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPTJLBInitial Entry
5.b
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850970
Page 164 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
11:34:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BPTJL
9Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-07-2020
11:34:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPTJL9Initial Entry
5.c
Date Location User Value Reason
Sep-07-2020
11:34:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BPTJL
8Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-07-2020
11:34:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPTJL8Initial Entry
5.d
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850971
Page 165 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-07-2020
11:34:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPHNT
YInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-07-2020
11:34:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPHNTYInitial Entry
5.e
Date Location User Value Reason
Sep-07-2020
11:34:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPHNT
XInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-07-2020
11:34:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPHNTXInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850972
Page 166 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020
11:13:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020
11:13:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020
11:14:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-07-2020
11:13:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850973
Page 167 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Sep-07-2020
11:13:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/5/2020Initial Entry
5.a
Date Location User Value Reason
Sep-07-2020
11:14:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPTJK4Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-07-2020
11:14:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPTJK4Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850974
Page 168 of 236
***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: 12261545 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-07-2020
09:11:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-07-2020
09:11:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-07-2020
09:11:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-07-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0850975
Page 169 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
09:11:56
(UTC-03:00) City
of Buenos AiresSep/5/2020 12:04
5. Anatomical Location:
Date Location User Value Reason
Sep-07-2020
09:11:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-07-2020
09:11:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-07-2020
09:11:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850976
Page 170 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-07-2020
09:11:56
(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-07-2020
09:11:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850977
Page 171 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-07-2020
09:12:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850978
Page 172 of 236
***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: 12261545 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-24-2020
13:01:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850979
Page 173 of 236
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020
13:01:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
2.a
Date Location User Value Reason
Sep-24-2020
13:01:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.5
Temperatur
e Unit:C
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-24-2020
13:01:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850980
Page 174 of 236
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.a Temperature:
Date Location User Value Reason
Sep-24-2020
13:01:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-24-2020
13:01:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-24-2020
13:01:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850981
Page 175 of 236
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-24-2020
13:01:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-24-2020
13:01:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-24-2020
13:01:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850982
Page 176 of 236
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-24-2020
13:01:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-24-2020
13:01:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-24-2020
13:01:52
(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:
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850983
Page 177 of 236
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-24-2020
13:01:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-24-2020
13:01:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-24-2020
13:01:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850984
Page 178 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020
09:24:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020
09:24:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020
09:24:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-25-2020
09:24:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850985
Page 179 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Sep-25-2020
09:24:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020
09:24:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BP7X8
WInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-25-2020
09:24:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BP7X8WInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850986
Page 180 of 236
***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: 12261545 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-24-2020
13:05:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020
13:05:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020
13:05:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-24-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0850987
Page 181 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
13:05:44
(UTC-03:00) City
of Buenos AiresSep/24/2020 09:06
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020
13:05:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-24-2020
13:05:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-24-2020
13:05:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850988
Page 182 of 236
***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: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-24-2020
13:05:44
(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-24-2020
13:05:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850989
Page 183 of 236
***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: 12261545 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-22-2020
10:51:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/22/2020Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850990
Page 184 of 236
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020
17:18:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020
17:18:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020
17:18:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-22-2020
17:18:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850991
Page 185 of 236
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Oct-22-2020
17:18:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020
17:18:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BR6NN
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-22-2020
17:18:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BR6NN1Initial Entry
5.b
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850992
Page 186 of 236
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-22-2020
17:18:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BS858
0Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020
17:18:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BS8580Initial Entry
5.c
Date Location User Value Reason
Oct-22-2020
17:18:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BS858
1Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020
17:18:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BS8581Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0850993
Page 187 of 236
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-23-2021
11:13:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/23/2021Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0850994
Page 188 of 236
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-23-2021
17:00:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-23-2021
17:00:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-23-2021
17:00:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-23-2021
17:00:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0850995
Page 189 of 236
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
are entered.
Please review
and correct as
appropriate.
Mar-23-2021
17:00:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Mar/23/2021Initial Entry
5.a
Date Location User Value Reason
Mar-23-2021
17:00:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BRGDP
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-23-2021
17:00:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BRGDPVInitial Entry
5.b
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0850996
Page 190 of 236
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Mar-23-2021
17:00:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BSCX6
HInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-23-2021
17:00:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BSCX6HInitial Entry
5.c
Date Location User Value Reason
Mar-23-2021
17:00:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BSCX6
JInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-23-2021
17:00:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BSCX6JInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0850997
Page 191 of 236
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-22-2020
10:51:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020
10:51:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020
10:51:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850998
Page 192 of 236
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-01-2021
09:11:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/22/2021Initial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0850999
Page 193 of 236
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-01-2021
09:11:38
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-01-2021
09:11:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-01-2021
09:11:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible and N
OT confirmed tInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851000
Page 194 of 236
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
o have received
only placebo at
Vaccination 1/2
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851001
Page 195 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Sep-24-2020
13:02:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851002
Page 196 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Sep-24-2020
13:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851003
Page 197 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Sep-28-2020
12:03:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851004
Page 198 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Sep-28-2020
12:04:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851005
Page 199 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Sep-28-2020
12:04:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851006
Page 200 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Oct-22-2020
10:55:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851007
Page 201 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Sep-24-2020
13:02:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-24-2020
13:02:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-24-2020
13:02:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
headacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851008
Page 202 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-24-2020
13:02:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/5/2020 17:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-24-2020
13:02:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/7/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-24-2020
13:02:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851009
Page 203 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-24-2020
13:02:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-24-2020
13:02:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-24-2020
13:02:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-24-2020
13:02:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851010
Page 204 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-24-2020
13:02:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-24-2020
13:02:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-24-2020
13:02:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-24-2020
13:02:46
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851011
Page 205 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851012
Page 206 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Sep-24-2020
13:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-24-2020
13:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-24-2020
13:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Pain at injection siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851013
Page 207 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-24-2020
13:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/5/2020 17:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-24-2020
13:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/7/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-24-2020
13:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851014
Page 208 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-24-2020
13:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-24-2020
13:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-24-2020
13:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-24-2020
13:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851015
Page 209 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-24-2020
13:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-24-2020
13:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-24-2020
13:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-24-2020
13:03:36
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851016
Page 210 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851017
Page 211 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Sep-28-2020
12:03:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-28-2020
12:03:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-28-2020
12:03:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
headacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851018
Page 212 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-28-2020
12:03:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/24/2020 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-28-2020
12:03:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/24/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-28-2020
12:03:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851019
Page 213 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-28-2020
12:03:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-28-2020
12:03:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-28-2020
12:03:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-28-2020
12:03:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851020
Page 214 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-28-2020
12:03:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-28-2020
12:03:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-28-2020
12:03:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-28-2020
12:03:24
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851021
Page 215 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851022
Page 216 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Sep-28-2020
12:04:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-28-2020
12:04:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-28-2020
12:04:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
muscle painInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851023
Page 217 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-28-2020
12:04:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/24/2020 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-28-2020
12:04:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/25/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-28-2020
12:04:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
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).
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851024
Page 218 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-28-2020
12:04:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-28-2020
12:04:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-28-2020
12:04:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-28-2020
12:04:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851025
Page 219 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-28-2020
12:04:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-28-2020
12:04:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-28-2020
12:04:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-28-2020
12:04:10
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851026
Page 220 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851027
Page 221 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Sep-28-2020
12:04:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-28-2020
12:04:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-21-2020
11:33:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-21-2020
08:00:23
(UTC-03:00) CityACV0PFEINFP6000 Query 1: Answered The possible
relation
between the
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0851028
Page 222 of 236
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de
Investigacao Clinica e Servicos Medicos Ltda
Subject No: 12261545 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
of Buenos Aires vacine and the
event is due to
2 motives: a)
the event
developed on
the same arm
side the
subject
received the
injection; b)
the event
happened 1
day after the
injection,
occurring,
ttherefore, a
temporal
relationship
Oct-15-2020
17:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened Clinquery:
Why this AE
is related?
Sep-28-2020
12:04:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
enlargement of left
axillary lymph nodeInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae406e\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851029
Pa
…[truncated]