Document text
Page 1 of 158
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890404
Page 2 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/31/2020
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890405
Page 3 of 158
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Demography
1.Subject ID [12315559]
2.Birth Date: /1971
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0890406
Page 4 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890407
Page 5 of 158
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890408
Page 6 of 158
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890409
Page 7 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Bronchial asthma]
Start Date: Jul/1/1987
Ongoing: YES
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890410
Page 8 of 158
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [102.65]
3.Unit: kg
4.Height: [173.0]
5.Unit: cm
6.Body Mass Index: [34.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890411
Page 9 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [74692]
3.Randomization Group: [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890412
Page 10 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BNV3J6]
5.bSample ID [BNV3J7]
5.cSample ID [BPTDHT]
5.dSample ID [BPTDHV]
5.eSample ID [BPTDHW]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890413
Page 11 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BP25N2]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890414
Page 12 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/31/2020 10:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890415
Page 13 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890416
Page 14 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/19/2020
2.Erroneous Visit
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890417
Page 15 of 158
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Sep/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890418
Page 16 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/19/2020
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 [BPWDYJ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890419
Page 17 of 158
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/19/2020 10:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890420
Page 18 of 158
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890421
Page 19 of 158
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
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 [BJ5MY9]
5.bSample ID [BJ5MVY]
5.cSample ID [BKVDYC]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890422
Page 20 of 158
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/13/2021
2.Erroneous Visit
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890423
Page 21 of 158
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/13/2021
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 [BRYGWS]
5.bSample ID [BPT61V]
5.cSample ID [BRYGXD]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890424
Page 22 of 158
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890425
Page 23 of 158
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890426
Page 24 of 158
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890427
Page 25 of 158
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890428
Page 26 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890429
Page 27 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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: [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890430
Page 28 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890431
Page 29 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890432
Page 30 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890433
Page 31 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890434
Page 32 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890435
Page 33 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890436
Page 34 of 158
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890437
Page 35 of 158
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unplanned Assessments
1.Assessments
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890438
Page 36 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890439
Page 37 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890440
Page 38 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890441
Page 39 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890442
Page 40 of 158
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890443
Page 41 of 158
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890444
Page 42 of 158
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890445
Page 43 of 158
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890446
Page 44 of 158
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890447
Page 45 of 158
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890448
Page 46 of 158
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890449
Page 47 of 158
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890450
Page 48 of 158
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890451
Page 49 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890452
Page 50 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890453
Page 51 of 158
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#CategoryAE Ide
ntifierAdverse Even
tStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Left axillar ade
nomegaly Sep/20/202
0 10:00 NO
End Date Time:
Sep/26/2020 18:00
Repeating
Pages
2.ADVERSE
EVENT 2 Fatigue Sep/19/202
0 21:00 NO
End Date Time:
Sep/20/2020 17:00
Repeating
Pages
3.ADVERSE
EVENT 3 generalized m
yalgia Sep/19/202
0 21:00 NO
End Date Time:
Sep/20/2020 17:00
Repeating
Pages
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890454
Page 52 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Left axillar adenomegaly]
4.Start Date Time: Sep/20/2020 10:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/26/2020 18:00
6.Toxicity Grade: 2
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890455
Page 53 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890456
Page 54 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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[ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890457
Page 55 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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)[Fatigue]
4.Start Date Time: Sep/19/2020 21:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/20/2020 17:00
6.Toxicity Grade: 1
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890458
Page 56 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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:
[Unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890459
Page 57 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
11.Was a Concomitant
Medication given?YES
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[ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890460
Page 58 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[generalized myalgia]
4.Start Date Time: Sep/19/2020 21:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/20/2020 17:00
6.Toxicity Grade: 1
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890461
Page 59 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890462
Page 60 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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[ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890463
Page 61 of 158
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890464
Page 62 of 158
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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[ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890465
Page 63 of 158
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890466
Page 64 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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: //
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890467
Page 65 of 158
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890468
Page 66 of 158
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890469
Page 67 of 158
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890470
Page 68 of 158
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890471
Page 69 of 158
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890472
Page 70 of 158
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890473
Page 71 of 158
***Confidential***
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890474
Page 72 of 158
***Confidential***
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890475
Page 73 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/17/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890476
Page 74 of 158
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890477
Page 75 of 158
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890478
Page 76 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/21/2020
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890479
Page 77 of 158
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890480
Page 78 of 158
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Fernando
Polack Approved Mar-16-2021 18:29:02 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, 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.
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890481
Page 79 of 158
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-31-2020 11:57:19 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890482
Page 80 of 158
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Fernando
Polack Approved Mar-16-2021 18:29:02 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Mar-13-2021 12:25:30 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Yanina
Rivera Approved Feb-18-2021 15:09:32 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0890483
Page 81 of 158
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, YaninaRivera, 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-17-2021 13:59:47 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-17-2020 22:54:04 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0890484
Page 82 of 158
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, , verify that all case report form pages
accurately display the results of the examinations, tests, evaluations and treatments performed on
this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Nov-17-2020 19:40:16 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-26-2020 22:12:53 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0890485
Page 83 of 158
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, , 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.
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0890486
Page 84 of 158
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-31-2020
11:56:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020
11:56:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890487
Page 85 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-31-2020
11:56:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/31/2020Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890488
Page 86 of 158
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020
10:00:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12315559Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020
10:00:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1971Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020
11:56:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890489
Page 87 of 158
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
11:56:37
(UTC-03:00) City
of Buenos AiresHISPANIC OR LATI
NO(A) OR OF SPAN
ISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-31-2020
11:56:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890490
Page 88 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020
11:57:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890491
Page 89 of 158
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-31-2020
11:57:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020
11:57:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020
11:57:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890492
Page 90 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.a
Date Location User Value Reason
Aug-31-2020
11:58:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Bronchia
l asthma
Start Date: Jul/1/198
7
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-31-2020
11:58:26
(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
Aug-31-2020
11:58:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Bronchial asthmaInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890493
Page 91 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.a Start Date:
Date Location User Value Reason
Aug-31-2020
11:58:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Jul/1/1987Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-31-2020
11:58:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890494
Page 92 of 158
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020
11:59:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020
11:59:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
102.65Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020
11:59:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-0890495
Page 93 of 158
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-31-2020
11:59:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
173.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-31-2020
11:59:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-31-2020
11:59:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
34.3Initial Entry
7.a
Date Location User Value Reason
Aug-31-2020
11:59:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.7Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-0890496
Page 94 of 158
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020
11:59:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-31-2020
11:59:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-31-2020
11:59:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-0890497
Page 95 of 158
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
7.a Temperature Location:
Date Location User Value Reason
Aug-31-2020
11:59:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890498
Page 96 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-31-2020
11:59:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-31-2020
11:59:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
74692Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890499
Page 97 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020
11:59:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020
11:59:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020
11:14:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-01-2020
04:45:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890500
Page 98 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
are entered.
Please review
and correct as
appropriate.
Aug-31-2020
11:59:43
(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.
Aug-31-2020
11:59:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020
11:14:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
Sample I
D:BNV3J
6Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0890501
Page 99 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-01-2020
11:14:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
BNV3J6Initial Entry
5.b
Date Location User Value Reason
Sep-01-2020
11:14:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
Sample I
D:BNV3J
7Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020
11:14:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
BNV3J7Initial Entry
5.c
Date Location User Value Reason
Sep-01-2020
13:46:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPTDH
TInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890502
Page 100 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.c Sample ID
Date Location User Value Reason
Sep-01-2020
13:46:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPTDHTInitial Entry
5.d
Date Location User Value Reason
Sep-01-2020
13:46:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPTDH
VInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-01-2020
13:46:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPTDHVInitial Entry
5.e
Date Location User Value Reason
Sep-01-2020
13:46:25
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
Sample I
D:BPTDH
WInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890503
Page 101 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
of Buenos Aires
5.e Sample ID
Date Location User Value Reason
Sep-01-2020
13:46:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPTDHWInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890504
Page 102 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020
11:59:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020
11:59:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020
10:42:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-01-2020
04:45:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890505
Page 103 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
are entered.
Please review
and correct as
appropriate.
Aug-31-2020
11:59:52
(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.
Aug-31-2020
11:59:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020
10:42:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BP25N
2Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0890506
Page 104 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-01-2020
10:42:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BP25N2Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890507
Page 105 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020
12:00:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020
12:00:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020
12:00:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890508
Page 106 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
12:00:13
(UTC-03:00) City
of Buenos AiresAug/31/2020 10:30
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020
12:00:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020
12:00:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-31-2020
12:00:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890509
Page 107 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-31-2020
12:00:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-31-2020
12:00:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890510
Page 108 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-31-2020
12:00:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890511
Page 109 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-19-2020
12:35:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890512
Page 110 of 158
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Sep-19-2020
12:36:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020Initial Entry
2.a
Date Location User Value Reason
Sep-19-2020
12:36:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.1
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-19-2020
12:36:06
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890513
Page 111 of 158
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
of Buenos Aires
2.a Temperature:
Date Location User Value Reason
Sep-19-2020
12:36:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
36.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-19-2020
12:36:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-19-2020
12:36:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890514
Page 112 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-19-2020
12:36:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-19-2020
12:36:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-19-2020
13:00:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-19-2020
12:36:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890515
Page 113 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
are entered.
Please review
and correct as
appropriate.
Sep-19-2020
12:36:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/19/2020Initial Entry
5.a
Date Location User Value Reason
Sep-19-2020
13:00:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPWD
YJInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-19-2020
13:00:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPWDYJInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890516
Page 114 of 158
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-19-2020
12:36:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-19-2020
12:36:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-19-2020
12:36:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-19-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890517
Page 115 of 158
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
12:36:25
(UTC-03:00) City
of Buenos AiresSep/19/2020 10:42
5. Anatomical Location:
Date Location User Value Reason
Sep-19-2020
12:36:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-19-2020
12:36:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-19-2020
12:36:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890518
Page 116 of 158
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-19-2020
12:36:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-19-2020
12:36:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890519
Page 117 of 158
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-21-2020
18:05:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0890520
Page 118 of 158
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020
18:05:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020
18:05:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020
18:35:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-21-2020
18:05:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890521
Page 119 of 158
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
are entered.
Please review
and correct as
appropriate.
Oct-21-2020
18:05:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020
18:35:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BJ5MY
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020
18:35:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BJ5MY9Initial Entry
5.b
Date Location User Value Reason
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890522
Page 120 of 158
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-22-2020
11:43:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BJ5MV
YInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020
11:43:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BJ5MVYInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020
14:46:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample I
D:BKVDY
CInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020
14:46:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BKVDYCInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890523
Page 121 of 158
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-13-2021
12:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/13/2021Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890524
Page 122 of 158
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-13-2021
12:25:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-13-2021
12:25:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-13-2021
13:07:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-13-2021
12:25:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890525
Page 123 of 158
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
are entered.
Please review
and correct as
appropriate.
Mar-13-2021
12:25:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/13/2021Initial Entry
5.a
Date Location User Value Reason
Mar-13-2021
13:07:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BRYG
WSInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-13-2021
13:07:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BRYGWSInitial Entry
5.b
Date Location User Value Reason
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890526
Page 124 of 158
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Mar-13-2021
13:43:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPT61
VInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-13-2021
13:43:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPT61VInitial Entry
5.c
Date Location User Value Reason
Mar-13-2021
15:11:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BRYGX
DInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-13-2021
15:11:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BRYGXDInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0890527
Page 125 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-21-2020
18:06:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020
18:06:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020
18:06:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890528
Page 126 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-17-2021
13:59:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/17/2021Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890529
Page 127 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-17-2021
14:00:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing t
o return for Vaccinati
on 3
Participant is:
eligible and NOT c
onfirmed to have r
eceived only place
bo at Vaccination 1
/2Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890530
Page 128 of 158
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Sep-25-2020
11:23:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890531
Page 129 of 158
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Sep-27-2020
09:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0890532
Page 130 of 158
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Sep-27-2020
09:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0890533
Page 131 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category:
Date Location User Value Reason
Sep-25-2020
11:23:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-25-2020
11:23:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-25-2020
11:23:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Left axillar adenomeg
alyInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890534
Page 132 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-25-2020
11:23:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/20/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-28-2020
12:21:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/26/2020 18:0
0New
Information
Sep-25-2020
11:23:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-25-2020
11:23:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (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) (4), (b)
(6)
FDA-CBER-2021-5683-0890535
Page 133 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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
Sep-25-2020
11:23:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-25-2020
11:23:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-12-2020
14:46:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Samuel
DychterQuery 2: Closed Response
satisfies query
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0890536
Page 134 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-12-2020
11:47:00
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed
Information
Oct-12-2020
11:47:00
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
RELATEDChanged
Information
Oct-05-2020
19:29:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Samuel
DychterQuery 2: Reissued:
OpenedResponse does
not satisfy
query
Oct-03-2020
08:13:55
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-02-2020
13:40:20
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New
Information
Oct-02-2020
13:40:20
(UTC-03:00)
City of BuenosACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New
Information
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890537
Page 135 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aires
Oct-02-2020
13:40:20
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to s
tudy treatment(s),
this event is due t
o:
OTHER
If Other, specif
y:
UnknownNew
Information
Sep-30-2020
03:02:20
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Samuel
DychterQuery 2: Opened GPD: The
event occurred
one day after
vaccine dose
2. Please
clarify why it
was assessed
as not related.
Sep-28-2020
11:38:36
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Opened DM: The
response for
"Is this event
related to
study
treatment" Is
reported as
'Not Related',
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0890538
Page 136 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
however
response for,
'Please
indicate what
this event is
due to' is
missing.
Kindly review
and update.
Sep-25-2020
11:23:21
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-25-2020
11:23:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-25-2020
11:23:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-0890539
Page 137 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-25-2020
11:23:21
(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
Oct-02-2020
13:40:41
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Close
dClose Auto Query
Oct-02-2020
13:40:41
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
RECOVERED/
RESOLVEDNew Information
Sep-28-2020
12:21:45
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Open
edFor AE Left axillar
adenomegaly:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890540
Page 138 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-25-2020
11:23:21
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
RECOVERIN
G/RESOLVIN
GInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-25-2020
11:23:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890541
Page 139 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category:
Date Location User Value Reason
Sep-27-2020
09:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-27-2020
09:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-27-2020
09:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
FatigueInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0890542
Page 140 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-27-2020
09:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020 21:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-27-2020
09:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/20/2020 17:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-17-2020
19:40:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1New
Information
Sep-27-2020
09:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0890543
Page 141 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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
Sep-27-2020
09:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-27-2020
09:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-03-2020
08:13:33
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-02-2020
13:41:17ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New
Information
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0890544
Page 142 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00)
City of Buenos
Aires
Oct-02-2020
13:41:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to s
tudy treatment(s),
this event is due t
o:
OTHER
If Other, specif
y:
UnknownNew
Information
Sep-28-2020
11:39:34
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Opened DM: The
response for
"If Not
Related to
study
treatment(s),
this event is
due to is
reported as
"Other",
however
specify is
missing?
kindly review
and update.
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890545
Page 143 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-27-2020
09:05:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to s
tudy treatment(s),
this event is due t
o:
OTHERInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-27-2020
09:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-27-2020
09:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-27-2020
09:05:42ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0890546
Page 144 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City
of Buenos Aires
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-27-2020
09:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-27-2020
09:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0890547
Page 145 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category:
Date Location User Value Reason
Sep-27-2020
09:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-27-2020
09:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-08-2020
12:33:58
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-07-2020
20:36:04ACV0PFEINFP6000 Query 1: Answer
edthe adverse event
is considered if it
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890548
Page 146 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00)
City of Buenos
Aireswas related to the
research product.
Due to this, it
was ruled out that
the symptom
could correspond
to a probable
covid-19 disease
symptom, so a
SARS-CoV-2
swab was not
performed.
Thank you.
Oct-06-2020
18:46:38
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Reissue
d:OpenedCLINQUERY:
Please complete
the potential
COVID Illness
Visit CRF forms
with all
information
available.
NASAL SWAB
will not be
collected.
Protocol
deviation will be
documented.
Oct-05-2020
18:38:13
(UTC-03:00)
City of BuenosACV0PFEINFP6000 Query 1: Answer
edFor the subject in
question, the
covid disease
form is not
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890549
Page 147 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aires reported because
it is not
interpreted at the
discretion of the
investigator in
charge as
symptoms of
covid disease.
Thank you.
Oct-02-2020
15:48:08
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Reissue
d:OpenedCLINREQUERY:
Per section 8.13,
AE of
MYALGIA
should have
triggered a
COVID
ILLNESS VISIT.
If confirmed,
please update all
possible forms in
COVID
ILLNESS VISIT.
Please indicate
swab was not
performed in
COVID
ILLNESS VISIT
and provide the
reason.
Oct-02-2020
15:43:47ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890550
Page 148 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00)
City of Buenos
Aires
Oct-02-2020
14:28:12
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Answer
edNew Information
Oct-02-2020
14:28:12
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edNew Information
Oct-02-2020
14:28:12
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
generalized myal
giaNew Information
Oct-02-2020
14:27:14
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 2: Reissue
d:OpenedCLINQUERY:
Thank you for
clarifying the
myalgias were
generalized.
Please update the
event term in the
CRF to specify as
such. Thank you.
Oct-02-2020
13:43:19ACV0PFEINFP6000 Query 2: Answer
edIt is clarified that
the adverse event
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890551
Page 149 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00)
City of Buenos
Airesmyalgias were
generalized.
Thank you
Sep-28-2020
15:44:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 2: Opened CLINQUERY:
Please update the
CRF to specify
anatomical site in
the event term. If
generalized,
please state as
such. Thank you.
Sep-28-2020
14:28:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Per section 8.13,
AE of
MYALGIA
should have
triggered a
COVID
ILLNESS VISIT.
If confirmed,
please update all
possible forms in
COVID
ILLNESS VISIT.
Please indicate
swab was not
performed in
COVID
ILLNESS VISIT
and provide the
reason.
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890552
Page 150 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-27-2020
09:10:02
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
MyalgiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-27-2020
09:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020 21:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-27-2020
09:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/20/2020 17:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-27-2020
09:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0890553
Page 151 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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
Sep-27-2020
09:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-27-2020
09:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-07-2020
20:33:52
(UTC-03:00)
City of BuenosACV0PFEINFP6000 Data Entry:
RELATEDNew
Information
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0890554
Page 152 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aires
Oct-03-2020
08:14:28
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-02-2020
13:42:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New
Information
Oct-02-2020
13:42:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to s
tudy treatment(s),
this event is due to
:
OTHER
If Other, specif
y:
UnknownNew
Information
Sep-28-2020
11:38:57
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Opened DM: The
response for
"Is this event
related to
study
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0890555
Page 153 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
treatment" Is
reported as
'Not Related',
however
response for,
'Please
indicate what
this event is
due to' is
missing.
Kindly review
and update.
Sep-27-2020
09:10:02
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-27-2020
09:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-27-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0890556
Page 154 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
09:10:02
(UTC-03:00) City
of Buenos AiresYES
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-27-2020
09:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-27-2020
09:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-27-2020
09:10:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0890557
Page 155 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-17-2021
13:59:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/17/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-17-2021
13:59:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890558
Page 156 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-21-2020
18:06:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-31-2020
11:59:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-31-2020
11:57:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-21-2020
18:06:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
Aug-31-2020
11:59:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890559
Page 157 of 158
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-31-2020
11:57:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890560
Page 158 of 158
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315559 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-26-2020
22:12:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2ecd\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0890561