125742 S1 M5 CRF c4591001 4444 44442021

Document text

Page 1 of 161
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version08 SEP 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006389
Page 2 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/25/2020
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006390
Page 3 of 161
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Demography
1.Subject ID [44442021]
2.Birth Date: /1974
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006391
Page 4 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006392
Page 5 of 161
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006393
Page 6 of 161
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006394
Page 7 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Ventricular extrasystole]
Start Date: Mar/3/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Surgical ablation for ventricular extrasystole]
Start Date: Apr/3/2015
Ongoing: NO
End Date:
Apr/3/2015
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006395
Page 8 of 161
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006396
Page 9 of 161
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
2.Weight: [81.7]
3.Unit: kg
4.Height: [173.0]
5.Unit: cm
6.Body Mass Index: [27.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006397
Page 10 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/25/2020
2.Randomization Number: [100399]
3.Randomization Group: [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006398
Page 11 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BKPG5N]
5.bSample ID [BRVS2K]
5.cSample ID [BRVS2C]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006399
Page 12 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BPWSBV]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006400
Page 13 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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/25/2020 18:43
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
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006401
Page 14 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006402
Page 15 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006403
Page 16 of 161
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Oct/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006404
Page 17 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
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 [BKNZGM]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006405
Page 18 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/15/2020 13:43
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
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006406
Page 19 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006407
Page 20 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/13/2020
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 [BRVR49]
5.bSample ID [BPTBB6]
5.cSample ID [BRVSHT]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006408
Page 21 of 161
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006409
Page 22 of 161
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006410
Page 23 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006411
Page 24 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006412
Page 25 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006413
Page 26 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006414
Page 27 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006415
Page 28 of 161
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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: [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006416
Page 29 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006417
Page 30 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006418
Page 31 of 161
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006419
Page 32 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006420
Page 33 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006421
Page 34 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006422
Page 35 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006423
Page 36 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006424
Page 37 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006425
Page 38 of 161
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unplanned Assessments
1.Assessments
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006426
Page 39 of 161
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#CategoryAE Iden
tifierAdverse Ev
entStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Right ankle
fracture Nov/15/202
0 10:00 NO
End Date Time:
Jan/21/2021 15:00
 Repeating
Pages
 2.ADVERSE
EVENT 2  fall from a b
icycle Nov/15/202
0 10:00 NO
End Date Time:
Nov/15/2020 10:01
 Repeating
Pages
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006427
Page 40 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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)[Right ankle fracture]
4.Start Date Time: Nov/15/2020 10:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/21/2021 15:00
6.Toxicity Grade: 3
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006428
Page 41 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
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:
[bike fall]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006429
Page 42 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021137954]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006430
Page 43 of 161
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[fall from a bicycle]
4.Start Date Time: Nov/15/2020 10:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/15/2020 10:01
6.Toxicity Grade: 2
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006431
Page 44 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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:
[fall from a bicycle]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006432
Page 45 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006433
Page 46 of 161
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006434
Page 47 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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[ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006435
Page 48 of 161
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006436
Page 49 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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: //
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006437
Page 50 of 161
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006438
Page 51 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006439
Page 52 of 161
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006440
Page 53 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006441
Page 54 of 161
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006442
Page 55 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006443
Page 56 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006444
Page 57 of 161
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006445
Page 58 of 161
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006446
Page 59 of 161
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006447
Page 60 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006448
Page 61 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006449
Page 62 of 161
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006450
Page 63 of 161
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/8/2021
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006451
Page 64 of 161
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWCZ1]
5.bSample ID [BRVGR5]
5.cSample ID [BRVGPG]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006452
Page 65 of 161
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPXWMK]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006453
Page 66 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006454
Page 67 of 161
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/18/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006455
Page 68 of 161
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/18/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/18/2021
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 [BRMDDB]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006456
Page 69 of 161
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/03/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK4
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006457
Page 70 of 161
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/03/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
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 [BP1Z7J]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006458
Page 71 of 161
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006459
Page 72 of 161
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006460
Page 73 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/3/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006461
Page 74 of 161
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006462
Page 75 of 161
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006463
Page 76 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/13/2020
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006464
Page 77 of 161
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006465
Page 78 of 161
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006466
Page 79 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-27-2020 08:40:46
(UTC-03:00) City of Buenos AiresNot Applicable
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006467
Page 80 of 161
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Agustin
Morato
Cabral N/A Mar-04-2021 14:33:02 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-04-2021 12:13:50 (UTC-03:00)
City of Buenos AiresBOOK Signed
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 Feb-19-2021 15:40:03 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006468
Page 81 of 161
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
N/A
 Approved Feb-16-2021 11:53:29 (UTC-03:00)
City of Buenos AiresBOOK Signed
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 Feb-08-2021 14:51:38 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-15-2020 10:36:21 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006469
Page 82 of 161
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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-13-2020 17:19:32 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria
Beretta Approved Nov-10-2020 11:43:23 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006470
Page 83 of 161
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, MariaBeretta, 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.
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006471
Page 84 of 161
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-27-2020
08:39:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-27-2020
08:39:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006472
Page 85 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-27-2020
08:39:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Con
sent Obtained
Sep/25/2020Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006473
Page 86 of 161
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-25-2020
17:30:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
44442021Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-25-2020
17:30:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1974Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-27-2020
08:40:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-27-2020
08:40:03ACV0PFEINFP6000  Data Entry:
HISPANIC OR LAInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006474
Page 87 of 161
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresTINO(A) OR OF S
PANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-27-2020
08:40:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006475
Page 88 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-27-2020
08:40:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006476
Page 89 of 161
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-27-2020
08:41:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-27-2020
08:41:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-27-2020
08:41:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006477
Page 90 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Sep-27-2020
08:48:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Ventricula
r extrasyst
ole
Start Date
:Mar/3/201
5
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-27-2020
08:48:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-27-2020
08:48:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Ventricular extrasy
stoleInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006478
Page 91 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.a Start Date:
Date Location User Value Reason
Sep-27-2020
08:48:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/3/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-27-2020
08:48:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-27-2020
08:49:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:2
Medic
al Hist
ory Te
rm:Surgical ablati
on for ventric
ular extrasysto
le
Start D
ate:Apr/3/2015Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006479
Page 92 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Ongoi
ng:NO
End Date:
Apr/3/2015
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006480
Page 93 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.b Line/MH Number:
Date Location User Value Reason
Sep-27-2020
08:49:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-27-2020
08:49:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Surgical ablation fo
r ventricular extras
ystoleInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-27-2020
08:49:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Apr/3/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-27-2020
08:49:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006481
Page 94 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Apr/3/2015
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006482
Page 95 of 161
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-27-2020
08:50:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
The subject is NOT
known to be HIV P
OSITIVEInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006483
Page 96 of 161
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Sep-27-2020
08:51:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-27-2020
08:51:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
81.7Initial Entry
3. Unit:
Date Location User Value Reason
Sep-27-2020
08:51:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-27-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006484
Page 97 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
08:51:34
(UTC-03:00) City
of Buenos Aires173.0
5. Unit:
Date Location User Value Reason
Sep-27-2020
08:51:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-27-2020
08:51:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.3Initial Entry
7.a
Date Location User Value Reason
Sep-27-2020
08:51:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperat
ure:37.3
Temperat
ure Unit:CInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006485
Page 98 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Temperat
ure Locat
ion::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-27-2020
08:51:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-27-2020
08:51:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
37.3Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-27-2020
08:51:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006486
Page 99 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-27-2020
08:51:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006487
Page 100 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-27-2020
08:52:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-27-2020
08:52:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
100399Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006488
Page 101 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-27-2020
08:55:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-27-2020
08:55:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-27-2020
10:58:20
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-27-2020
08:55:59
(UTC-03:00)
City of BuenosACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006489
Page 102 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Aires are entered.
Please review
and correct as
appropriate.
Sep-27-2020
08:55:59
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-27-2020
10:58:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BKPG5
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-27-2020
10:58:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BKPG5NInitial Entry
5.b
Date Location User Value Reason
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006490
Page 103 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-27-2020
11:12:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BRVS2
KInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-27-2020
11:12:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRVS2KInitial Entry
5.c
Date Location User Value Reason
Sep-27-2020
11:53:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Sample ID
:BRVS2
CInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-27-2020
11:53:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
BRVS2CInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006491
Page 104 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-27-2020
08:58:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-27-2020
08:58:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-27-2020
10:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-27-2020
08:58:17
(UTC-03:00)
City of BuenosACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006492
Page 105 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Aires are entered.
Please review
and correct as
appropriate.
Sep-27-2020
08:58:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-27-2020
10:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample I
D:BPWSB
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-27-2020
10:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BPWSBVInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006493
Page 106 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-27-2020
08:56:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-27-2020
08:56:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-27-2020
08:56:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-27-2020
08:56:46ACV0PFEINFP6000  Data Entry:
Sep/25/2020 18:43Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006494
Page 107 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Sep-27-2020
08:56:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-27-2020
08:56:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-27-2020
08:56:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-27-2020
08:56:46ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006495
Page 108 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-27-2020
08:56:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006496
Page 109 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-27-2020
08:58:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTE
D FOR THIS SUB
JECTInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1006497
Page 110 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020
17:32:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006498
Page 111 of 161
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Oct-15-2020
17:33:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2.a
Date Location User Value Reason
Oct-15-2020
17:33:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:37.2
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-15-2020
17:33:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006499
Page 112 of 161
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
2.a Temperature:
Date Location User Value Reason
Oct-15-2020
17:33:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
37.2Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-15-2020
17:33:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-15-2020
17:33:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006500
Page 113 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020
17:07:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020
17:07:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
17:07:52
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-15-2020
17:07:41
(UTC-03:00)
City of BuenosACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006501
Page 114 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Aires are entered.
Please review
and correct as
appropriate.
Oct-15-2020
17:07:41
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Alan Colombo Data Entry:
YES
Date of Collectio
n:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020
17:07:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BKNZG
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020
17:07:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BKNZGMInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006502
Page 115 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-15-2020
17:33:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-15-2020
17:33:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-15-2020
17:33:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-15-2020
17:33:27ACV0PFEINFP6000  Data Entry:
Oct/15/2020 13:43Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006503
Page 116 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Oct-15-2020
17:33:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-15-2020
17:33:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-15-2020
17:33:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-15-2020
17:33:27ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006504
Page 117 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-15-2020
17:33:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006505
Page 118 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-13-2020
17:19:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/13/2020Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006506
Page 119 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020
17:19:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020
17:19:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-14-2020
10:34:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-13-2020
21:50:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1006507
Page 120 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Nov-13-2020
17:19:51
(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.
Nov-13-2020
17:19:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/13/2020Initial Entry
5.a
Date Location User Value Reason
Nov-14-2020
10:34:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BRVR4
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-14-2020
10:34:12
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
BRVR49Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006508
Page 121 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
5.b
Date Location User Value Reason
Nov-14-2020
12:09:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPTBB
6Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-14-2020
12:09:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTBB6Initial Entry
5.c
Date Location User Value Reason
Nov-14-2020
13:37:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Sample I
D:BRVSH
TInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006509
Page 122 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.c Sample ID
Date Location User Value Reason
Nov-14-2020
13:37:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
BRVSHTInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006510
Page 123 of 161
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Feb-09-2021
10:42:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006511
Page 124 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Feb-09-2021
14:56:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1006512
Page 125 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Feb-09-2021
10:42:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-09-2021
10:42:29
(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
Feb-09-2021
10:42:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Right ankle fractureInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-09-2021 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1006513
Page 126 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
10:42:29
(UTC-03:00) City
of Buenos AiresNov/15/2020 10:00
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-09-2021
10:42:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/21/2021 15:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-09-2021
10:42:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1006514
Page 127 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-26-2021
00:12:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Feb-22-2021
11:11:32
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Answere
dPlease clarify
the request, in
the FU on
17FEB21 the
following was
sent: "I clarify
that during the
hospitalization
no COVID test
was performed."
Feb-22-2021
10:03:36
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Reissued
:OpenedClinical - Thank
you; however
the 17Feb21
SAE update did
not include a
statement about
COVID testing
in hospital
Feb-17-2021
16:08:27
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Answere
dIt is clarified
that during the
hospitalization
no COVID test
was performed.
Adverse event
follow-up form
is sent to the
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006515
Page 128 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
sponsor with
such
clarification.
Feb-17-2021
01:06:46
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Reissued
:OpenedClinical - Thank
you; however
the 11Feb21
SAE update did
not include a
statement about
COVID testing
in hospital
Feb-11-2021
17:35:50
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Answere
dA follow-up
form for the
serious adverse
event is sent
where it is
clarified that a
test for Covid
was not
performed
because the
adverse event is
not associated
with Covid
disease, in
addition the
patient did not
present
symptoms of
Covid disease.
Feb-10-2021 ACV0PFEINFP6000  auto query Query 1: Deleted Close Auto
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006516
Page 129 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
23:10:53
(UTC-03:00)
City of Buenos
Aires(autoquery) Query
Feb-10-2021
15:05:26
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Opened Clinical COVID
test status
(yes/no) during
Hosp/surgery
was not
reported in the
SAE. Please
submit a
follow-up SAE
form
[#2021137954]
to document if
COVID testing
was performed
(YES/NO or
info not
available) and if
yes, the date
and results.
Feb-09-2021
10:42:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eFor AE Right
ankle fracture:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006517
Page 130 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
blank.
Feb-09-2021
10:42:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious ev
ent associated wi
th congenital an
omaly or birth d
efect?
NO
Did this serious
event result in de
ath?
NO
Did this serious
event require or
prolong hospitali
zation?
YES
Did this serious
event result in pe
rsistent or signifi
cant disability/in
capacity?
NO
Is this serious evInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1006518
Page 131 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
ent life threateni
ng?
NO
Other medically
important seriou
s event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-09-2021
10:42:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-09-2021
10:42:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006519
Page 132 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
bike fall
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-09-2021
10:42:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-09-2021
10:42:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-09-2021
10:42:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006520
Page 133 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-09-2021
10:42:29
(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
Feb-09-2021
10:42:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-10-2021
23:10:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2021137954Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1006521
Page 134 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Feb-09-2021
14:56:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-09-2021
14:56:50
(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
Feb-09-2021
14:56:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
fall from a bicycleInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1006522
Page 135 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-09-2021
14:56:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/15/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-09-2021
14:56:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/15/2020 10:0
1Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-09-2021
14:56:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1006523
Page 136 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Feb-09-2021
14:56:50
(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
Feb-09-2021
14:56:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-09-2021
14:56:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
fall from a bicy
cleInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1006524
Page 137 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-09-2021
14:56:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-09-2021
14:56:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-09-2021
14:56:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-09-2021
14:56:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVED WITH SEQ
UELAEInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1006525
Page 138 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-09-2021
14:56:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1006526
Page 139 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-13-2020
17:20:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-13-2020
17:20:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-13-2020
17:20:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006527
Page 140 of 161
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-08-2021
14:51:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/8/2021Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006528
Page 141 of 161
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-08-2021
14:51:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Feb/8/2021Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006529
Page 142 of 161
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-08-2021
14:52:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-08-2021
14:52:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-09-2021
11:37:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-09-2021
07:43:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006530
Page 143 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Feb-08-2021
14:52:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-08-2021
14:52:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/8/2021Initial Entry
5.a
Date Location User Value Reason
Feb-09-2021
11:37:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPWCZ
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-09-2021
11:37:29
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
BPWCZ1Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006531
Page 144 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
5.b
Date Location User Value Reason
Feb-09-2021
13:52:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRVGR
5Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-09-2021
13:52:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRVGR5Initial Entry
5.c
Date Location User Value Reason
Feb-09-2021
14:23:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRVGP
GInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006532
Page 145 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.c Sample ID
Date Location User Value Reason
Feb-09-2021
14:23:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRVGPGInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006533
Page 146 of 161
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-08-2021
16:36:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-08-2021
16:36:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-09-2021
12:50:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-09-2021
07:43:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006534
Page 147 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Feb-08-2021
16:36:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-08-2021
16:36:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/8/2021Initial Entry
5.a
Date Location User Value Reason
Feb-09-2021
12:50:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPXW
MKInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-09-2021
12:50:25
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
BPXWMKInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006535
Page 148 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006536
Page 149 of 161
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/18/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-19-2021
15:40:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/18/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-19-2021
15:40:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SSWAB_WEEK2Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006537
Page 150 of 161
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/18/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-19-2021
15:40:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-19-2021
15:40:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-19-2021
15:40:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-19-2021
15:40:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006538
Page 151 of 161
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/18/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Feb-19-2021
15:40:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Feb/18/2021Initial Entry
5.a
Date Location User Value Reason
Feb-19-2021
15:40:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRMDD
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-19-2021
15:40:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRMDDBInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006539
Page 152 of 161
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/03/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021
14:33:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Mar/3/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Mar-04-2021
14:33:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
SSWAB_WEEK4Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006540
Page 153 of 161
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/03/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-04-2021
14:33:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-04-2021
14:33:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-04-2021
14:33:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-04-2021
14:33:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006541
Page 154 of 161
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/03/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Mar-04-2021
14:33:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
YES
Date of Collection
:
Mar/3/2021Initial Entry
5.a
Date Location User Value Reason
Mar-04-2021
14:33:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Sample ID
:BP1Z7
JInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-04-2021
14:33:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
BP1Z7JInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006542
Page 155 of 161
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-03-2021
11:26:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/3/2021Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1006543
Page 156 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-03-2021
11:29:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-03-2021
11:29:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Mar-03-2021
11:29:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willin
g to return for Vacc
ination 3
Participant is:
eligible and NO
T confirmed to h
ave received onl
y placebo at VacInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1006544
Page 157 of 161
***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, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
cination 1/2
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006545
Page 158 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-03-2021
11:29:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/3/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-03-2021
11:29:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1006546
Page 159 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-13-2020
17:20:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-27-2020
08:52:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-27-2020
08:41:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-13-2020
17:20:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/13/2020Initial Entry
Sep-27-2020
08:52:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006547
Page 160 of 161
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-27-2020
08:41:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006548
Page 161 of 161
***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, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020
11:43:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Maria Beretta Data Entry:
Click Here to EnableInitial Entry
090177e196ae2e6a\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006549