125742 S1 M5 CRF c4591001 1226 12262240

Document text

Page 1 of 173
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856463
Page 2 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/16/2020
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856464
Page 3 of 173
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Demography
1.Subject ID [12262240]
2.Birth Date: 1944
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856465
Page 4 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856466
Page 5 of 173
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856467
Page 6 of 173
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856468
Page 7 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes mellitus type 2]
Start Date: Oct/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypothyroidism]
Start Date: Oct/UNK/1999
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Systemic arterial hypertension]
Start Date: Oct/UNK/2005
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Menopause]
Start Date: UNK/UNK/1993
Ongoing: YES
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856469
Page 8 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoporosis]
Start Date: Nov/UNK/2019
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fracture of left femur]
Start Date: Nov/UNK/2019
Ongoing: NO
End Date:
Feb/UNK/2020
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856470
Page 9 of 173
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856471
Page 10 of 173
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Vital Signs
1.Date: Oct/16/2020
2.Weight: [73.2]
3.Unit: kg
4.Height: [165.8]
5.Unit: cm
6.Body Mass Index: [26.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856472
Page 11 of 173
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/16/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856473
Page 12 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/16/2020
2.Randomization Number: [270059]
3.Randomization Group: [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856474
Page 13 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
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 [BR77WM]
5.bSample ID [BRVBYF]
5.cSample ID [BRVBYD]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856475
Page 14 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
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 [BR77VH]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856476
Page 15 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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: Oct/16/2020 12:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856477
Page 16 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856478
Page 17 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856479
Page 18 of 173
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Vital Signs
1.Date: Jan/8/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: FOREHEAD
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856480
Page 19 of 173
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/8/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856481
Page 20 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/8/2021
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 [BP992Z]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856482
Page 21 of 173
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Applicable Comments
2.Treatment Name Not Applicable
[ ]Comments
3.Formulation: Not Applicable Comments
4.Dose Date Time: Not Applicable
//Comments
5.Anatomical Location: Not Applicable Comments
6.Body Side: Not Applicable Comments
7.Route: Not Applicable Comments
8.Actual Dose: Not Applicable
[ ]Comments
9.Unit: Not Applicable Comments
10.Timeframe Subject Was Observed Not Applicable Comments
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?Not Applicable Comments
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856483
Page 22 of 173
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856484
Page 23 of 173
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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 [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856485
Page 24 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856486
Page 25 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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: [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856487
Page 26 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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 [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856488
Page 27 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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 [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856489
Page 28 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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?
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856490
Page 29 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856491
Page 30 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856492
Page 31 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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 [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856493
Page 32 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856494
Page 33 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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 [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856495
Page 34 of 173
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856496
Page 35 of 173
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Unplanned Assessments
1.Assessments
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856497
Page 36 of 173
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856498
Page 37 of 173
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856499
Page 38 of 173
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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:
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856500
Page 39 of 173
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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?
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856501
Page 40 of 173
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856502
Page 41 of 173
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856503
Page 42 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/25/2020
2.Phase of Disposition: VACCINATION
3.Status: PHYSICIAN DECISION
4.Specify Status: [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856504
Page 43 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856505
Page 44 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856506
Page 45 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856507
Page 46 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856508
Page 47 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/5/2021
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856509
Page 48 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856510
Page 49 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Feb/5/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856511
Page 50 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/5/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856512
Page 51 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/5/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6863]
5.bSample ID [BSCW40]
5.cSample ID [BSCW4F]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856513
Page 52 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/5/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRH022]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856514
Page 53 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/5/2021 11:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856515
Page 54 of 173
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856516
Page 55 of 173
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/26/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856517
Page 56 of 173
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6146]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856518
Page 57 of 173
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/26/2021 10:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856519
Page 58 of 173
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856520
Page 59 of 173
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856521
Page 60 of 173
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856522
Page 61 of 173
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856523
Page 62 of 173
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856524
Page 63 of 173
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856525
Page 64 of 173
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856526
Page 65 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Fracture of the right
femur Oct/24/2020 UNK
:UNK NO
End Date Time:
Oct/29/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  fall from own heigh
t Oct/24/2020 UNK
:UNK NO
End Date Time:
Oct/24/2020 UNK:UNK
 Repeating
Pages
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856527
Page 66 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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)[Fracture of the right femur]
4.Start Date Time: Oct/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/29/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856528
Page 67 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Accidental cause: patient fell after being knocked over by a dog]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020416919]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856529
Page 68 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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)[fall from own height]
4.Start Date Time: Oct/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/24/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[was knocked down on the street by a dog]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856530
Page 69 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
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[ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856531
Page 70 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856532
Page 71 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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[ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856533
Page 72 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856534
Page 73 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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: //
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856535
Page 74 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856536
Page 75 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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?
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856537
Page 76 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856538
Page 77 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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?
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856539
Page 78 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856540
Page 79 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856541
Page 80 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/28/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856542
Page 81 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856543
Page 82 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856544
Page 83 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/25/2020
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856545
Page 84 of 173
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856546
Page 85 of 173
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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-04-2021 12:25:37 (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.
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856547
Page 86 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
ItemDate User Comment
FormOct-17-2020 08:29:46 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856548
Page 87 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
ItemDate User Comment
FormJan-08-2021 16:13:59 (UTC-03:00) City of
Buenos AiresSubject is discontinued from the vaccine.
Not Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856549
Page 88 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
ItemDate User Comment
1Jan-08-2021 16:13:59 (UTC-03:00) City of
Buenos AiresSubject is discontinued from the vaccine.
Not Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856550
Page 89 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
ItemDate User Comment
2Jan-08-2021 16:13:59 (UTC-03:00) City of
Buenos AiresSubject is discontinued from the vaccine.
Not Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856551
Page 90 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
ItemDate User Comment
3Jan-08-2021 16:13:59 (UTC-03:00) City of
Buenos AiresSubject is discontinued from the vaccine.
Not Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856552
Page 91 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
ItemDate User Comment
4Jan-08-2021 16:13:59 (UTC-03:00) City of
Buenos AiresSubject is discontinued from the vaccine.
Not Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856553
Page 92 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
ItemDate User Comment
5Jan-08-2021 16:13:59 (UTC-03:00) City of
Buenos AiresSubject is discontinued from the vaccine.
Not Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856554
Page 93 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
ItemDate User Comment
6Jan-08-2021 16:13:59 (UTC-03:00) City of
Buenos AiresSubject is discontinued from the vaccine.
Not Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856555
Page 94 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
ItemDate User Comment
7Jan-08-2021 16:13:59 (UTC-03:00) City of
Buenos AiresSubject is discontinued from the vaccine.
Not Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856556
Page 95 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
ItemDate User Comment
8Jan-08-2021 16:13:59 (UTC-03:00) City of
Buenos AiresSubject is discontinued from the vaccine.
Not Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856557
Page 96 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
ItemDate User Comment
9Jan-08-2021 16:13:59 (UTC-03:00) City of
Buenos AiresSubject is discontinued from the vaccine.
Not Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856558
Page 97 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
ItemDate User Comment
10Jan-08-2021 16:13:59 (UTC-03:00) City of
Buenos AiresSubject is discontinued from the vaccine.
Not Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856559
Page 98 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
ItemDate User Comment
11Jan-08-2021 16:13:59 (UTC-03:00) City of
Buenos AiresSubject is discontinued from the vaccine.
Not Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856560
Page 99 of 173
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
ItemDate User Comment
FormFeb-05-2021 13:54:30 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856561
Page 100 of 173
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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-04-2021 12:25:37 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-26-2021 12:10:13 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Feb-12-2021 16:48:23 (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.
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856562
Page 101 of 173
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-17-2020 08:28:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-17-2020 08:28:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856563
Page 102 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-17-2020 08:28:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/16/2020Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856564
Page 103 of 173
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - 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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-17-2020 08:28:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12262240Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-17-2020 08:26:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1944Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-17-2020 08:29:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-17-2020 08:29:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-17-2020 08:29:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856565
Page 104 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-17-2020 08:29:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856566
Page 105 of 173
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-17-2020 08:30:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-17-2020 08:30:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-17-2020 08:30:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856567
Page 106 of 173
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1.a
Date Location User Value Reason
Oct-17-2020 08:37:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical Histor
y Term:Diabetes mellitu
s type 2
Start Date: Oct/UNK/2000
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-17-2020 08:37:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-17-2020 08:37:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Diabetes mellitus type 2Initial Entry
1.a Start Date:
Date Location User Value Reason
Oct-17-2020 08:37:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-17-2020 08:37:48
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856568
Page 107 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Buenos Aires
1.b
Date Location User Value Reason
Oct-17-2020 08:38:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:hypothyroidi
sm
Start Date: Oct/UNK/19
99
Ongoing: YESInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856569
Page 108 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
1.b Line/MH Number:
Date Location User Value Reason
Oct-17-2020 08:38:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-17-2020 08:38:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
hypothyroidismInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-17-2020 08:38:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/UNK/1999Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-17-2020 08:38:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-17-2020 08:38:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:Systemic arterial
hypertension
Start Date: Oct/UNK/2005
Ongoing: YESInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856570
Page 109 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
1.c Line/MH Number:
Date Location User Value Reason
Oct-17-2020 08:38:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-17-2020 08:38:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Systemic arterial hypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-17-2020 08:38:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/UNK/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-17-2020 08:38:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-27-2020 17:18:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Menopause
Start Date: UNK/UNK/1
993Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856571
Page 110 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Oct-27-2020 17:18:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-27-2020 17:18:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
MenopauseInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-27-2020 17:18:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/1993Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-27-2020 17:18:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-27-2020 17:18:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:Osteoporosis
Start Date: Nov/UNK/2
019
Ongoing: YESInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856572
Page 111 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
1.e Line/MH Number:
Date Location User Value Reason
Oct-27-2020 17:18:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-27-2020 17:18:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OsteoporosisInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-27-2020 17:18:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/UNK/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-27-2020 17:18:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-27-2020 17:19:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:Fracture of left f
emur
Start Date: Nov/UNK/2019Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856573
Page 112 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Ongoing: NO
End Date:
Feb/UNK/20
20
1.f Line/MH Number:
Date Location User Value Reason
Oct-27-2020 17:19:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-27-2020 17:19:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Fracture of left femurInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-27-2020 17:19:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/UNK/2019Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-27-2020 17:19:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Feb/UNK/2020Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856574
Page 113 of 173
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-17-2020 08:38:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856575
Page 114 of 173
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Date:
Date Location User Value Reason
Oct-17-2020 08:39:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-17-2020 08:39:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
73.2Initial Entry
3. Unit:
Date Location User Value Reason
Oct-17-2020 08:39:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-17-2020 08:39:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
165.8Initial Entry
5. Unit:
Date Location User Value Reason
Oct-17-2020 08:39:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856576
Page 115 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
6. Body Mass Index:
Date Location User Value Reason
Oct-17-2020 08:39:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26.6Initial Entry
7.a
Date Location User Value Reason
Oct-17-2020 08:39:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.4
Temperature Unit: C
Temperature Locat
ion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-17-2020 08:39:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-17-2020 08:39:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-17-2020 08:39:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856577
Page 116 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
7.a Temperature Location:
Date Location User Value Reason
Oct-17-2020 08:39:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856578
Page 117 of 173
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-17-2020 08:40:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-17-2020 08:40:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-17-2020 08:40:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-17-2020 08:40:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-17-2020 08:40:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856579
Page 118 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Oct-17-2020 08:40:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-17-2020 08:40:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-17-2020 08:40:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-17-2020 08:40:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856580
Page 119 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-17-2020 08:41:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-17-2020 08:41:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
270059Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856581
Page 120 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-17-2020 11:03:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-17-2020 11:03:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-17-2020 11:03:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-17-2020 11:03:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-17-2020 11:03:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-17-2020 11:03:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR77WMInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856582
Page 121 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
5.a Sample ID
Date Location User Value Reason
Oct-17-2020 11:03:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR77WMInitial Entry
5.b
Date Location User Value Reason
Oct-17-2020 11:03:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRVBYFInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-17-2020 11:03:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRVBYFInitial Entry
5.c
Date Location User Value Reason
Oct-17-2020 11:03:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRVBYDInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-17-2020 11:03:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRVBYDInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856583
Page 122 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-17-2020 10:36:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-17-2020 10:36:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-17-2020 10:36:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-17-2020 10:36:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-17-2020 10:36:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-17-2020 10:36:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR77VHInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856584
Page 123 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
5.a Sample ID
Date Location User Value Reason
Oct-17-2020 10:36:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR77VHInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856585
Page 124 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-17-2020 08:42:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-17-2020 08:42:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-17-2020 08:42:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-17-2020 08:42:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/16/2020 12:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-17-2020 08:42:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856586
Page 125 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Oct-17-2020 08:42:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-17-2020 08:42:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-17-2020 08:42:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-17-2020 08:42:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856587
Page 126 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-17-2020 08:42:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856588
Page 127 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Date of Visit
Date Location User ValueReason
Jan-12-2021
06:50:57
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: Clo
sedAs per site
confirmation -
updated PD tracker
Jan-11-2021
07:36:01
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: An
swere
dSubject came out of
the window due
unavailability.
Jan-11-2021
02:15:14
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V2_VAX2_L is out
of window for 61
days from
V1_DAY1_VAX1_L
Dose Date. Please
verify and update.
Else, confirm in
query response
appropriately. 
Jan-08-2021
16:11:44
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
Jan/8/
2021Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0856589
Page 128 of 173
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Date:
Date Location User Value Reason
Jan-08-2021 16:12:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/8/2021Initial Entry
2.a
Date Location User Value Reason
Jan-08-2021 16:12:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.3
Temperature Unit: C
Temperature Locat
ion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-08-2021 16:12:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Jan-08-2021 16:12:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.3Initial Entry
2.a Unit:
Date Location User Value Reason
Jan-08-2021 16:12:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856590
Page 129 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
2.a Temperature Location:
Date Location User Value Reason
Jan-08-2021 16:12:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856591
Page 130 of 173
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-08-2021 16:12:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-08-2021 16:12:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-08-2021 16:12:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/8/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-08-2021 16:12:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-08-2021 16:12:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856592
Page 131 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Jan-08-2021 16:12:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-08-2021 16:12:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-08-2021 16:12:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Jan-08-2021 16:12:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856593
Page 132 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-08-2021 17:01:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-08-2021 17:01:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-08-2021 17:01:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-08-2021 17:01:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-08-2021 17:01:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/8/2021Initial Entry
5.a
Date Location User Value Reason
Jan-08-2021 17:01:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP992ZInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856594
Page 133 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
5.a Sample ID
Date Location User Value Reason
Jan-08-2021 17:01:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP992ZInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856595
Page 134 of 173
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-08-2021 16:13:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-08-2021 16:13:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-08-2021 16:13:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-08-2021 16:13:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-08-2021 16:13:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856596
Page 135 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Jan-08-2021 16:13:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Route:
Date Location User Value Reason
Jan-08-2021 16:13:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-08-2021 16:13:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Unit:
Date Location User Value Reason
Jan-08-2021 16:13:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-08-2021 16:13:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-08-2021 16:13:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856597
Page 136 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-26-2020 10:17:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-26-2020 10:17:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-04-2020 08:45:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Dec-03-2020 07:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Answer Auto Query
Dec-03-2020 03:58:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Reissued:Opened DM: Thank you for
response. Please
confirm if response
to status is
‘PHYSICIAN
DECISION’ if yes
then remove
response to field
‘Specify Status:’ on
this page and update
CRF. Else clarify.
Dec-02-2020 15:38:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856598
Page 137 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Dec-02-2020 07:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered Data updated. The
field did not allow a
detailed
explanation.
Dec-02-2020 07:44:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to
"Status" is
PHYSICIAN
DECISION but
"Specify Status" is
Provided.
Dec-02-2020 02:44:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Reissued:Opened Response doesn't
satisfy query. Please
select a more
appropriate option
at field 'Status'. Or
remove data entered
at field 'Specify
status'.
Dec-01-2020 10:36:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered query response
Dec-01-2020 10:35:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered completed
Dec-01-2020 10:35:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to
"Status" is
PHYSICIAN
DECISION but
"Specify Status" is
Provided.
Nov-30-2020 14:14:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Clinical: Please
complete in status
discontinued due to
physician decision,
and if possible
explain why this
decision. Thanks
Nov-26-2020 10:17:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PHYSICIAN DECISIONInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856599
Page 138 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
4. Specify Status:
Date Location User Value Reason
Dec-03-2020 07:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Per query
resolution.
Dec-02-2020 07:44:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PI decided to discontinue due to
clinical condition and prolonged
SAE recoveryNew Information
Dec-01-2020 10:35:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
due to clinical condition and pro
longed SAE recovery [fracute o
f the right femur]Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856600
Page 139 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-05-2021 13:53:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856601
Page 140 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-05-2021 13:53:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirmed
to have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856602
Page 141 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-05-2021 13:54:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/5/2021Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856603
Page 142 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-05-2021 13:54:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/5/2021Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856604
Page 143 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-05-2021 13:54:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/5/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-05-2021 13:54:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-05-2021 13:54:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856605
Page 144 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-05-2021 13:58:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-05-2021 13:58:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-05-2021 13:58:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/5/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-05-2021 13:58:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-05-2021 13:58:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856606
Page 145 of 173
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Feb-05-2021 13:58:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-05-2021 13:58:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-05-2021 13:58:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Feb-05-2021 13:58:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856607
Page 146 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-06-2021 07:44:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-06-2021 07:44:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-06-2021 07:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-06-2021 07:44:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-06-2021 07:44:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/5/2021Initial Entry
5.a
Date Location User Value Reason
Feb-06-2021 07:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR6863Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856608
Page 147 of 173
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
5.a Sample ID
Date Location User Value Reason
Feb-06-2021 07:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR6863Initial Entry
5.b
Date Location User Value Reason
Feb-06-2021 07:44:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BSCW40Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-06-2021 07:44:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BSCW40Initial Entry
5.c
Date Location User Value Reason
Feb-06-2021 07:45:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BSCW4FInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-06-2021 07:45:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BSCW4FInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856609
Page 148 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-05-2021 17:47:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-05-2021 17:47:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-05-2021 17:47:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-05-2021 17:47:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-05-2021 17:47:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/5/2021Initial Entry
5.a
Date Location User Value Reason
Feb-05-2021 17:47:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRH022Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856610
Page 149 of 173
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
5.a Sample ID
Date Location User Value Reason
Feb-05-2021 17:47:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRH022Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856611
Page 150 of 173
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-05-2021 13:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-05-2021 13:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-05-2021 13:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-05-2021 13:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/5/2021 11:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-05-2021 13:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856612
Page 151 of 173
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Feb-05-2021 13:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-05-2021 13:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-05-2021 13:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-05-2021 13:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-05-2021 13:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-05-2021 13:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856613
Page 152 of 173
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021 12:10:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/26/2021Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856614
Page 153 of 173
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-26-2021 12:11:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-26-2021 12:11:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-26-2021 12:11:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/26/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-26-2021 12:11:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-26-2021 12:11:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856615
Page 154 of 173
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Feb-26-2021 12:11:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-26-2021 12:11:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-26-2021 12:11:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Feb-26-2021 12:11:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856616
Page 155 of 173
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-27-2021 10:14:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-27-2021 10:14:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-27-2021 10:14:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-27-2021 10:14:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-27-2021 10:14:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/26/2021Initial Entry
5.a
Date Location User Value Reason
Feb-27-2021 10:14:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR6146Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856617
Page 156 of 173
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
5.a Sample ID
Date Location User Value Reason
Feb-27-2021 10:14:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR6146Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856618
Page 157 of 173
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-26-2021 12:12:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-26-2021 12:12:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-26-2021 12:12:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-26-2021 12:12:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/26/2021 10:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-26-2021 12:12:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856619
Page 158 of 173
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Feb-26-2021 12:12:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-26-2021 12:12:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-26-2021 12:12:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-26-2021 12:12:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-26-2021 12:12:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-26-2021 12:12:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856620
Page 159 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
Date Location User Value Reason
Oct-27-2020 14:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856621
Page 160 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
Date Location User Value Reason
Nov-04-2020 09:37:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856622
Page 161 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 14:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 14:55:46
(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
Nov-04-2020 10:58:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Appreciate the
prompt response.
Thank you.
Nov-03-2020 11:10:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The SI clarified on
source document
that she has not the
information if any
SARS-CoV-2 test
were performed.
Nov-01-2020 23:05:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Kindly confirm if
any SARS-CoV-2
(NAAT or other)
tests were
performed on the
SAE submitted to
safety. If test
performed = YES,
please provide FU
report with results.
If test was NOT
done or NOT
available, please FU
as well. Thanks
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0856623
Page 162 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Oct-27-2020 14:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Fracture of the right femurInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 14:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-30-2020 13:03:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/29/2020 UNK:UNKNew Information
Oct-27-2020 14:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-27-2020 14:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-28-2020 06:06:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856624
Page 163 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Oct-27-2020 14:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Fracture of
the right femur:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Oct-27-2020 14:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birth
defect?
NO
Did this serious event result in d
eath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disability/
incapacity?
NO
Is this serious event life threaten
ing?
NO
Other medically important serio
us event
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.
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856625
Page 164 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Date Location User Value Reason
Oct-27-2020 14:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-04-2020 14:03:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-04-2020 09:38:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered information
updated
Nov-02-2020 18:00:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery: Fall
should be recorded
as separate AE,
even if an injury
did not result.
When a fall results
in an injury, both
the injury and the
fall should be
recorded as AEs.
please update the
CRF.
Oct-27-2020 14:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
Accidental cause: patient
fell after being knocked o
ver by a dogInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856626
Page 165 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Oct-27-2020 14:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-27-2020 14:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-30-2020 13:04:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESNew Information
Oct-27-2020 14:55:46
(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
Nov-04-2020
08:34:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 3: Closed Response satisfies query
Nov-03-2020
11:04:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 3: Answered The FUP 1 was send and the status
was updated to
RECOVERD/RESOLVED on
30/Oct/2020
Nov-01-2020
09:45:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 3: Opened SAE
RECON:AER#2020416919,outcome
was updated to
RECOVERED/RESOLVED in AE
CRF. However, still recorded as
NOT RECOVERED/NOT
RESOLVED in Safety database
Please confirm correct outcome. If
safety update is required, please
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856627
Page 166 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
submit a follow-up form.
Oct-30-2020
13:04:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-30-2020
13:04:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDNew Information
Oct-30-2020
13:03:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE Fracture of the right femur:
Response to "What was the outcome
of this adverse event?" is 'Not
Recovered/Not Resolved' but AE
End Date/Time is present.
Oct-29-2020
01:16:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies query
Oct-28-2020
14:14:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-28-2020
14:14:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DNew Information
Oct-28-2020
06:09:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020416919,outcome
was reported as NOT
RECOVERED/NOT RESOLVED to
Safety DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Oct-27-2020
14:55:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERING/RE
SOLVINGInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856628
Page 167 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020 14:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-28-2020 06:06:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2020416919Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856629
Page 168 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Category:
Date Location User Value Reason
Nov-04-2020 09:37:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-04-2020 09:37:55
(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
Nov-04-2020 09:37:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
fall from own heightInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-04-2020 09:37:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-04-2020 09:37:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/24/2020 UNK:UNKInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856630
Page 169 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
6. Toxicity Grade:
Date Location User Value Reason
Nov-04-2020 09:37:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-04-2020 09:37:55
(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
Nov-04-2020 09:37:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-04-2020 09:37:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856631
Page 170 of 173
***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: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
was knocked down on the s
treet by a dog
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-04-2020 09:37:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-04-2020 09:37:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-04-2020 09:37:55
(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
Nov-04-2020 09:37:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-04-2020 09:37:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0856632
Page 171 of 173
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-05-2021 13:53:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/28/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-05-2021 13:53:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856633
Page 172 of 173
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-26-2020 10:17:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-17-2020 08:41:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-17-2020 08:30:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-26-2020 10:17:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/25/2020Initial Entry
Oct-17-2020 08:41:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/16/2020Initial Entry
Oct-17-2020 08:30:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/16/2020Initial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0856634
Page 173 of 173
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262240 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:23
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1. Casebook Signature
Date Location User Value Reason
Dec-08-2020 15:27:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae405a\Final\Final On: 01-Apr-2021 05:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0856635