125742 S1 M5 CRF c4591001 4444 44441473

Document text

Page 1 of 223
***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: 44441473 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
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003998
Page 2 of 223
***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: 44441473 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/22/2020
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003999
Page 3 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Demography
1.Subject ID [44441473]
2.Birth Date: /1944
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004000
Page 4 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004001
Page 5 of 223
***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: 44441473 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
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004002
Page 6 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004003
Page 7 of 223
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 44441473 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:[Arterial Hypertension]
Start Date: Mar/3/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypercholesterolemia]
Start Date: Mar/3/2005
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Anterior descending coronary artery obstruction]
Start Date: Feb/7/1999
Ongoing: NO
End Date:
Feb/7/1999
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004004
Page 8 of 223
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Anterior descending coronary artery stenosis]
Start Date: Mar/14/2020
Ongoing: NO
End Date:
Mar/14/2020
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Biliary lithiasis]
Start Date: May/16/1993
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Basal cell carcinoma]
Start Date: Mar/1/2018
Ongoing: NO
End Date:
Mar/1/2018
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004005
Page 9 of 223
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[smoking]
Start Date: Oct/1/1959
Ongoing: NO
End Date:
Feb/7/1999
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Benign prostatic hyperplasia]
Start Date: Mar/1/2010
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[low back pain]
Start Date: Feb/1/2005
Ongoing: NO
End Date:
Feb/1/2021
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004006
Page 10 of 223
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[surgical treatment for basal cell carcinoma]
Start Date: Mar/1/2018
Ongoing: NO
End Date:
Mar/1/2018
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004007
Page 11 of 223
***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: 44441473 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
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004008
Page 12 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
2.Weight: [85.0]
3.Unit: kg
4.Height: [173.0]
5.Unit: cm
6.Body Mass Index: [28.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004009
Page 13 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/22/2020
2.Randomization Number: [263915]
3.Randomization Group: [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004010
Page 14 of 223
***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: 44441473 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/22/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPXHS4]
5.bSample ID [BRVL9R]
5.cSample ID [BRVLB2]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004011
Page 15 of 223
***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: 44441473 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/22/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWTBK]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004012
Page 16 of 223
***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: 44441473 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/22/2020 17:57
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
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004013
Page 17 of 223
***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: 44441473 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
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004014
Page 18 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004015
Page 19 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Oct/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004016
Page 20 of 223
***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: 44441473 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/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 [BP1V7S]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004017
Page 21 of 223
***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: 44441473 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/13/2020 13:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004018
Page 22 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004019
Page 23 of 223
***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: 44441473 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/12/2020
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 [BNTRC6]
5.bSample ID [BP1PX8]
5.cSample ID [BNTR6N]
5.dSample ID [BPTB64]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004020
Page 24 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004021
Page 25 of 223
***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: 44441473 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 [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004022
Page 26 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004023
Page 27 of 223
***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: 44441473 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 [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004024
Page 28 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004025
Page 29 of 223
***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: 44441473 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 [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004026
Page 30 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/23/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004027
Page 31 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/23/2020
2.Date of First Symptom
Started:Nov/22/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/18/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004028
Page 32 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Dysphonia]
5.bSymptoms - Other Text: [Asthenia]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004029
Page 33 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
 1.Nov/23/
2020 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004030
Page 34 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/23/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASOPHARYNX
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004031
Page 35 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
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: 44441473 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_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[Sample collected by team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004032
Page 36 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: 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: 44441473 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:
Nov/23/2020
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 [BPW86H]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004033
Page 37 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004034
Page 38 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004035
Page 39 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004036
Page 40 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004037
Page 41 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?YES
Respiratory Illness Diagnosis:
[PHARYNGITIS]
Date of Diagnosis:
Nov/23/2020
3.Toxicity Grade: 1
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004038
Page 42 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004039
Page 43 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004040
Page 44 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004041
Page 45 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004042
Page 46 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004043
Page 47 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004044
Page 48 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004045
Page 49 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004046
Page 50 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004047
Page 51 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004048
Page 52 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004049
Page 53 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: OXYGENATION PARAMETERS
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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004050
Page 54 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004051
Page 55 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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.Start Date: //
6.Ongoing?
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004052
Page 56 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004053
Page 57 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004054
Page 58 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/28/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/28/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004055
Page 59 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/28/2020Form: 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: 44441473 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:
Dec/28/2020
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 [BRVNKS]
5.bSample ID [BRVNK1]
5.cSample ID [BPW8FY]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004056
Page 60 of 223
***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: 44441473 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:
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004057
Page 61 of 223
***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: 44441473 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 [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004058
Page 62 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004059
Page 63 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unplanned Assessments
1.Assessments
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004060
Page 64 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# CategoryAE Id
entifie
rAdverse Eve
ntStart Da
teIs the Adverse Ev
ent Still OngoingForm Insta
nce
 1. DELETED ADVERS
E EVEN
T 1 Biliary colic  Nov/2/2
020 22:0
0 NO
End Date Time:
Nov/3/2020 07:
00
 Repeating
Pages
 2. ADVERS
E EVEN
T 2 Worsening of
biliary lithiasi
s Nov/2/2
020 22:0
0 NO
End Date Time:
Mar/3/2021 18:
00
 Repeating
Pages
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004061
Page 65 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Biliary colic ]
4.Start Date Time: Nov/2/2020 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/3/2020 07:00
6.Toxicity Grade: 1
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004062
Page 66 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[Biliary lithiasis ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004063
Page 67 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004064
Page 68 of 223
***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: 44441473 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)[Worsening of biliary lithiasis]
4.Start Date Time: Nov/2/2020 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/3/2021 18:00
6.Toxicity Grade: 3
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004065
Page 69 of 223
***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: 44441473 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:
[History of gallstones]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004066
Page 70 of 223
***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: 44441473 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[2021191154]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004067
Page 71 of 223
***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: 44441473 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
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004068
Page 72 of 223
***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: 44441473 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[ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004069
Page 73 of 223
***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: 44441473 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
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004070
Page 74 of 223
***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: 44441473 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: //
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004071
Page 75 of 223
***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: 44441473 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
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004072
Page 76 of 223
***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: 44441473 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?
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004073
Page 77 of 223
***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: 44441473 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
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004074
Page 78 of 223
***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: 44441473 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?
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004075
Page 79 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004076
Page 80 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004077
Page 81 of 223
***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: 44441473 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/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004078
Page 82 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004079
Page 83 of 223
***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: 44441473 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:
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004080
Page 84 of 223
***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: 44441473 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?
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004081
Page 85 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004082
Page 86 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004083
Page 87 of 223
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004084
Page 88 of 223
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004085
Page 89 of 223
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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 [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004086
Page 90 of 223
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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 [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004087
Page 91 of 223
***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: 44441473 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: [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004088
Page 92 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004089
Page 93 of 223
***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, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004090
Page 94 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/18/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004091
Page 95 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004092
Page 96 of 223
***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: 44441473 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: [ ]
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004093
Page 97 of 223
***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: 44441473 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/12/2020
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004094
Page 98 of 223
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004095
Page 99 of 223
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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
Name Signature
MeaningDate Type Action
 Approved Mar-11-2021 15:19:46 (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.
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004096
Page 100 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-23-2020 10:47:56 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004097
Page 101 of 223
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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
Name Signature
MeaningDate Type Action
 Approved Mar-11-2021 15:19:46 (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-20-2021 16:13:42 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-21-2021 11:24:12 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004098
Page 102 of 223
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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 Dec-02-2020 14:28:41 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-25-2020 18:31:14 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004099
Page 103 of 223
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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-24-2020 20:13:01 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-14-2020 12:18:04 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004100
Page 104 of 223
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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 17:50:57 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-13-2020 09:37:23 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004101
Page 105 of 223
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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-12-2020 12:51:46 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-10-2020 11:38:35 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004102
Page 106 of 223
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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.
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004103
Page 107 of 223
***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: 44441473 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-23-2020
10:46:44
(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-23-2020
10:46:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004104
Page 108 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-23-2020
10:47:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/22/2020Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004105
Page 109 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-22-2020
17:06:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
44441473Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-22-2020
17:05:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1944Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-23-2020
10:47:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-23-2020
10:47:11ACV0PFEINFP6000  Data Entry:
HISPANIC OR LATIInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004106
Page 110 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresNO(A) OR OF SPAN
ISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-23-2020
10:47:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004107
Page 111 of 223
***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: 44441473 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-23-2020
10:47:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004108
Page 112 of 223
***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: 44441473 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-23-2020
10:48:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-23-2020
10:48:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-23-2020
10:48:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004109
Page 113 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Sep-23-2020
10:48:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Arterial H
ypertensio
n
Start Date
:Mar/3/20
05
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-23-2020
10:48:29
(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-23-2020
10:48:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Arterial HypertensionInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004110
Page 114 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.a Start Date:
Date Location User Value Reason
Sep-23-2020
10:48:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/3/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-23-2020
10:48:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-23-2020
10:48:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:Hyperchol
esterolemi
a
Start Date
:Mar/3/200
5
Ongoing: YESInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004111
Page 115 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.b Line/MH Number:
Date Location User Value Reason
Sep-23-2020
10:48:47
(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-23-2020
10:48:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
HypercholesterolemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-23-2020
10:48:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/3/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-23-2020
10:48:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004112
Page 116 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.c
Date Location User Value Reason
Nov-13-2020
08:32:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:3
Medic
al Hist
ory Te
rm:Anterior desce
nding coronar
y artery obstru
ction
Start
Date:Feb/7/1999
Ongoi
ng:NO
End Date:
Feb/7/1999Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004113
Page 117 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.c Line/MH Number:
Date Location User Value Reason
Nov-13-2020
08:32:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-13-2020
08:32:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Anterior descending c
oronary artery obstruc
tionInitial Entry
1.c Start Date:
Date Location User Value Reason
Nov-13-2020
08:32:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/7/1999Initial Entry
1.c Ongoing:
Date Location User Value Reason
Nov-13-2020
08:32:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004114
Page 118 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb/7/1999
1.d
Date Location User Value Reason
Nov-13-2020
08:33:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:4
Medic
al Hist
ory Te
rm:Anterior desce
nding coronar
y artery stenos
is
Start
Date:Mar/14/2020
Ongoi
ng:NO
End Date:
Mar/14/202
0Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004115
Page 119 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.d Line/MH Number:
Date Location User Value Reason
Nov-13-2020
08:33:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-13-2020
08:33:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Anterior descending c
oronary artery stenosi
sInitial Entry
1.d Start Date:
Date Location User Value Reason
Nov-13-2020
08:33:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/14/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Nov-13-2020
08:33:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004116
Page 120 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Mar/14/2020
1.e
Date Location User Value Reason
Nov-13-2020
08:33:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:Biliary l
ithiasis
Start Date: May/16/
1993
Ongoing: YESInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004117
Page 121 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.e Line/MH Number:
Date Location User Value Reason
Nov-13-2020
08:33:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-13-2020
08:33:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Biliary lithiasisInitial Entry
1.e Start Date:
Date Location User Value Reason
Nov-13-2020
08:33:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
May/16/1993Initial Entry
1.e Ongoing:
Date Location User Value Reason
Nov-13-2020
08:33:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004118
Page 122 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.f
Date Location User Value Reason
Mar-05-2021
10:08:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical H
istory Ter
m:Basal cell c
arcinoma
Start Date
:Mar/1/201
8
Ongoing: NO
End Date
:
Mar/1/2
018Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004119
Page 123 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.f Line/MH Number:
Date Location User Value Reason
Mar-05-2021
10:08:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-09-2021
17:27:59
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Mar-09-2021
12:22:46
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answe
redChanged data
per query
Mar-08-2021
12:29:55
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opene
dClinQuery:
Basal Cell
Carcinoma is
noted on
01Mar2018.
However, there
is no
corresponding
treatment.
Please confirm
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1004120
Page 124 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
the treatment
and update the
CRF as
appropriate.
Mar-05-2021
10:08:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Basal cell carcin
omaInitial Entry
1.f Start Date:
Date Location User Value Reason
Mar-05-2021
10:08:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Mar/1/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Mar-05-2021
10:08:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Mar/1/2018Initial Entry
1.g
Date Location User Value Reason
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004121
Page 125 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Mar-05-2021
10:09:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:7
Medical His
tory Term:smoking
Start Date: Oct/1/19
59
Ongoing: NO
End Da
te:
Feb/7
/1999Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004122
Page 126 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.g Line/MH Number:
Date Location User Value Reason
Mar-05-2021
10:09:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-05-2021
10:09:28
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
smokingInitial Entry
1.g Start Date:
Date Location User Value Reason
Mar-05-2021
10:09:28
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/1/1959Initial Entry
1.g Ongoing:
Date Location User Value Reason
Mar-05-2021
10:09:28ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004123
Page 127 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00)
City of Buenos
AiresEnd Date:
Feb/7/1999
1.h
Date Location User Value Reason
Mar-05-2021
10:10:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical
History T
erm:Benign pro
static hyper
plasia
Start Dat
e:Mar/1/2010
Ongoing: YESInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1004124
Page 128 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.h Line/MH Number:
Date Location User Value Reason
Mar-05-2021
10:10:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-05-2021
10:10:08
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Benign prostatic h
yperplasiaInitial Entry
1.h Start Date:
Date Location User Value Reason
Mar-05-2021
10:10:08
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Mar/1/2010Initial Entry
1.h Ongoing:
Date Location User Value Reason
Mar-05-2021
10:10:08ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004125
Page 129 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00)
City of Buenos
Aires
1.i
Date Location User Value Reason
Mar-05-2021
10:10:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:9
Medical His
tory Term:low back
pain
Start Date: Feb/1/20
05
Ongoing: NO
End Da
te:
Feb/1
/2021Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1004126
Page 130 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.i Line/MH Number:
Date Location User Value Reason
Mar-05-2021
10:10:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-05-2021
10:10:50
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
low back painInitial Entry
1.i Start Date:
Date Location User Value Reason
Mar-05-2021
10:10:50
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Feb/1/2005Initial Entry
1.i Ongoing:
Date Location User Value Reason
Mar-05-2021
10:10:50ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004127
Page 131 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00)
City of Buenos
AiresEnd Date:
Feb/1/2021
1.j
Date Location User Value Reason
Mar-09-2021
12:22:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Line/
MH N
umbe
r:10
Medic
al His
tory T
erm:surgical treat
ment for bas
al cell carcin
oma
Start
Date:Mar/1/2018
Ongoi
ng:NO
End Date:
Mar/1/20
18Transcription
Error
Mar-09-2021
12:22:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/
MH N
umbe
r:10Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004128
Page 132 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Medic
al His
tory T
erm:surgical treat
ment for bas
al cell carcin
oma
Start
Date:Mar/1/2019
Ongoi
ng:NO
End Date:
Mar/1/20
18
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004129
Page 133 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Mar-09-2021
12:22:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-09-2021
12:22:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
surgical treatment for
basal cell carcinomaInitial Entry
1.j Start Date:
Date Location User Value Reason
Mar-09-2021
12:22:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/1/2018Transcription
Error
Mar-09-2021
12:22:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/1/2019Initial Entry
1.j Ongoing:
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004130
Page 134 of 223
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Mar-09-2021
12:22:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-09-2021
12:22:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For Term
surgical
treatment for
basal cell
carcinoma
End Date is
prior to Start
Date.
Mar-09-2021
12:22:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Mar/1/2018Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004131
Page 135 of 223
***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: 44441473 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-23-2020
10:48:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
The subject is NOT k
nown to be HIV POSI
TIVEInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004132
Page 136 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020
10:49:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-23-2020
10:49:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
85.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-23-2020
10:49:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-23-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1004133
Page 137 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
10:49:09
(UTC-03:00) City
of Buenos Aires173.0
5. Unit:
Date Location User Value Reason
Sep-23-2020
10:49:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-23-2020
10:49:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.4Initial Entry
7.a
Date Location User Value Reason
Sep-23-2020
10:49:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.1
Temperatu
re Unit:CInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004134
Page 138 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-23-2020
10:49:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-23-2020
10:49:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-23-2020
10:49:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004135
Page 139 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-23-2020
10:49:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004136
Page 140 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-23-2020
10:49:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-23-2020
10:49:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
263915Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004137
Page 141 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020
10:49:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020
10:49:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020
13:28:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-23-2020
10:49:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004138
Page 142 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Sep-23-2020
10:49:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020
13:28:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPXHS
4Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-23-2020
13:28:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPXHS4Initial Entry
5.b
Date Location User Value Reason
Sep-23-2020
13:44:23
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Sample I BRVL9Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004139
Page 143 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires D: R
5.b Sample ID
Date Location User Value Reason
Sep-23-2020
13:44:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRVL9RInitial Entry
5.c
Date Location User Value Reason
Sep-23-2020
16:36:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BRVLB
2Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-23-2020
16:36:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BRVLB2Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1004140
Page 144 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020
10:49:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020
10:49:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020
14:57:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-23-2020
10:49:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004141
Page 145 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Sep-23-2020
10:49:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020
14:57:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPWTB
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-23-2020
14:57:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPWTBKInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004142
Page 146 of 223
***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: 44441473 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-23-2020
10:50:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020
10:50:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020
10:50:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-23-2020
10:50:52ACV0PFEINFP6000  Data Entry:
Sep/22/2020 17:57Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004143
Page 147 of 223
***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: 44441473 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-23-2020
10:50:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-23-2020
10:50:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-23-2020
10:50:52
(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-23-2020
10:50:52ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004144
Page 148 of 223
***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: 44441473 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-23-2020
10:50:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004145
Page 149 of 223
***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: 44441473 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-23-2020
10:50:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004146
Page 150 of 223
***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: 44441473 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-14-2020
16:05:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004147
Page 151 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Oct-14-2020
16:05:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
2.a
Date Location User Value Reason
Oct-14-2020
16:05:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.6
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-14-2020
16:05:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004148
Page 152 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
2.a Temperature:
Date Location User Value Reason
Oct-14-2020
16:05:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-14-2020
16:05:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-14-2020
16:05:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004149
Page 153 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020
17:32:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020
17:32:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020
17:32:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-13-2020
17:32:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004150
Page 154 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Oct-13-2020
17:32:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020
17:32:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP1V7
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-13-2020
17:32:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP1V7SInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004151
Page 155 of 223
***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: 44441473 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-14-2020
16:06:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-14-2020
16:06:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-14-2020
16:06:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-14-2020
16:06:17ACV0PFEINFP6000  Data Entry:
Oct/13/2020 13:20Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004152
Page 156 of 223
***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: 44441473 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-14-2020
16:06:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-14-2020
16:06:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Oct-14-2020
16:06:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-14-2020
16:06:17ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004153
Page 157 of 223
***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: 44441473 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-14-2020
16:06:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004154
Page 158 of 223
***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: 44441473 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-12-2020
13:39:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004155
Page 159 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-12-2020
13:39:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020
13:39:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-12-2020
16:47:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-12-2020
13:47:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004156
Page 160 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Nov-12-2020
13:39:19
(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-12-2020
13:39:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
Nov-12-2020
16:47:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BNTRC
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-12-2020
16:47:58ACV0PFEINFP6000  Alan Colombo Data Entry:
BNTRC6Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1004157
Page 161 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
5.b
Date Location User Value Reason
Nov-12-2020
18:44:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BP1PX
8Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-12-2020
18:44:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BP1PX8Initial Entry
5.c
Date Location User Value Reason
Nov-12-2020
18:57:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BNTR6
NInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1004158
Page 162 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.c Sample ID
Date Location User Value Reason
Nov-12-2020
18:57:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BNTR6NInitial Entry
5.d
Date Location User Value Reason
Nov-13-2020
17:57:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPTB6
4Transcription
Error
(DELETED)
Nov-13-2020
17:50:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPTB6
4Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1004159
Page 163 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.d Sample ID
Date Location User Value Reason
Nov-13-2020
17:57:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTB64Transcription
Error
(DELETED)
Nov-13-2020
17:50:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTB64Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004160
Page 164 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 44441473 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-24-2020
20:16:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Nov-24-2020
20:12:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
missing. Please
review and
update as
appropriate.
Nov-24-2020
20:12:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in
both Nasal
Swab Self and
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004161
Page 165 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nasal Swab
are missing.
Please review
and update as
appropriate.
Nov-24-2020
20:12:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/23/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-24-2020
20:12:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004162
Page 166 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/23/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/22/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-22-2020
15:32:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symp
tom Resolved:
Dec/18/2020New
Information
Dec-02-2020
14:28:41
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
YESNew
Information
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004163
Page 167 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symp
tom Resolved:
Nov/23/2020Initial Entry
4.a
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEVE
R
Symptom Pre
sent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-24-2020
20:14:20ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1004164
Page 168 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
4.b
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED
COUGH
Sympt
om Pre
sent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASE
D COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1004165
Page 169 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symp
toms:NEW OR INC
REASED SH
ORTNESS OF
BREATH
Symp
tom P
resen
t:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASE
D SHORTNESS OF B
REATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004166
Page 170 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHIL
LS
Symptom Pr
esent:NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE PA
INInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004167
Page 171 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sympt
om Pr
esent:NO
4.e Symptoms:
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASE
D MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pre
sent:NOInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004168
Page 172 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.f Symptoms:
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THROA
T
Sympt
om Pr
esent:YESInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004169
Page 173 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.g Symptoms:
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASE
D SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARR
HEA
Symptom P
resent:NOInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004170
Page 174 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.h Symptoms:
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMIT
ING
Symptom P
resent:NOInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004171
Page 175 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.i Symptoms:
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-24-2020
20:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Nov-24-2020
20:15:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms -
Other:Dysph
oniaInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Nov-24-2020
20:15:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
DysphoniaInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004172
Page 176 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.b
Date Location User Value Reason
Dec-02-2020
14:29:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms -
Other:Asthe
niaInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Dec-02-2020
14:29:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
AstheniaInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004173
Page 177 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Nov-24-2020
20:15:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004174
Page 178 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-24-2020
20:15:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/23/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-24-2020
20:15:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SWABBED MATERI
ALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-24-2020
20:15:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-24-2020
20:15:30ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004175
Page 179 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresP SYNDROME CORO
NAVIRUS 2
5. Device Type:
Date Location User Value Reason
Nov-24-2020
20:15:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGN
OSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-24-2020
20:15:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ATILA BIOSYSTEM
S IAMP COVID-19 D
ETECTION KITInitial Entry
7. Test Result:
Date Location User Value Reason
Nov-24-2020
20:15:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004176
Page 180 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - 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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-24-2020
20:16:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-24-2020
20:16:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-24-2020
20:16:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004177
Page 181 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - 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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nov-24-2020
20:16:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample collected by te
am physicianInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004178
Page 182 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: 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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-24-2020
20:16:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-24-2020
20:16:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-25-2020
08:39:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-25-2020
07:32:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004179
Page 183 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: 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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Nov-24-2020
20:16:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-24-2020
20:16:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/23/2020Initial Entry
5.a
Date Location User Value Reason
Nov-25-2020
08:39:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPW86
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-25-2020
08:39:02
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
BPW86HInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004180
Page 184 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: 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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004181
Page 185 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pract
itioner:SPEC
IALIS
T
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004182
Page 186 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pr
actitioner:EMERG
ENCY
ROOM
Occurrenc
e of Visits o
r Contacts:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Nov-24-2020
20:17:06ACV0PFEINFP6000  Data Entry:
Type of P PRIMARInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1004183
Page 187 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Airesractitione
r:Y CARE
PHYSICI
AN
Occurren
ce of Visit
s or Cont
acts:NO
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE PH
YSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:URGE
NT C
AREInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1004184
Page 188 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Occurrence
of Visits or
Contacts:NO
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of P
ractitione
r:TELEPH
ONE CO
NSULTA
TIONInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004185
Page 189 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Occurren
ce of Visit
s or Cont
acts:NO
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONS
ULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:OT
HE
R
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004186
Page 190 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Nov-24-2020
20:17:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004187
Page 191 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/23/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Nov-24-2020
20:17:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-
19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Nov-24-2020
20:17:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness
Diagnosis:
PHARYNGITIS
Date of Diagnosis:
Nov/23/2020Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-24-2020
20:17:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004188
Page 192 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/28/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-28-2020
14:30:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/28/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-28-2020
14:30:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004189
Page 193 of 223
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/28/2020Form: 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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-28-2020
14:30:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-28-2020
14:30:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-28-2020
16:29:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-28-2020
14:30:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004190
Page 194 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/28/2020Form: 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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Dec-28-2020
14:30:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/28/2020Initial Entry
5.a
Date Location User Value Reason
Dec-28-2020
16:29:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRVNK
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-28-2020
16:29:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRVNKSInitial Entry
5.b
Date Location User Value Reason
Dec-28-2020
16:33:25
(UTC-03:00) CityACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I BRVNKInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1004191
Page 195 of 223
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/28/2020Form: 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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires D: 1
5.b Sample ID
Date Location User Value Reason
Dec-28-2020
16:33:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BRVNK1Initial Entry
5.c
Date Location User Value Reason
Dec-28-2020
16:38:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BPW8F
YInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-28-2020
16:38:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPW8FYInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1004192
Page 196 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Feb-25-2021
16:25:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Deleted Transcription
Error
Nov-12-2020
12:51:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1004193
Page 197 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Feb-20-2021
16:13:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004194
Page 198 of 223
***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, Deleted, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Nov-12-2020
12:51:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-12-2020
12:51:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-12-2020
12:51:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Biliary colicInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004195
Page 199 of 223
***Confidential***
Nov-12-2020
12:51:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/2/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-12-2020
12:51:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/3/2020 07:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-12-2020
12:51:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-12-2020
12:51:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1004196
Page 200 of 223
***Confidential***
Nov-12-2020
12:51:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-12-2020
12:51:46
(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:
Biliary lithiasisInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-12-2020
12:51:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-12-2020
12:51:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-12-2020
12:51:46ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1004197
Page 201 of 223
***Confidential***
(UTC-03:00) City
of Buenos Aires
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-12-2020
12:51:46
(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
Nov-12-2020
12:51:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1004198
Page 202 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Feb-20-2021
16:13:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-20-2021
16:13:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-01-2021
14:52:14
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Mar-01-2021
14:52:05
(UTC-03:00)ACV0PFEINFP6000  Query 3: Closed Response
satisfies query
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004199
Page 203 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
City of Buenos
Aires
Mar-01-2021
14:51:55
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Closed Response
satisfies query
Feb-26-2021
10:35:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-25-2021
13:21:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answer
edI clarify that
there is not stop
date for SAE
'Worsening of
biliary lithiasis'
because this
event is ongoing,
althought
abdominal pain
improved after
surgery.
Feb-25-2021
13:20:02
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Answer
edI clarify that
thepatient
remained
hospitalized from
17 until 19 FEB
2021. FU SAE
form was sent
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1004200
Page 204 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
with this
information.
Feb-25-2021
13:19:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Answer
edI clarify that
when the subject
experienced
abiliary colic on
02Nov20 hewas
seen at
physician ́soffice,
but not atthe ER.
FU SAE form
was sent with
this information.
Feb-25-2021
13:18:30
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Answer
edFU SAE form
was sent with
this information.
Feb-23-2021
10:46:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Opened Clinical - please
submit the dates
of
Hospitalization
(it appears Feb
18-20) to the
SAE report in the
SAE event
section
Feb-23-2021
10:45:46
(UTC-03:00)ACV0PFEINFP6000  Query 3: Opened Clinical Please
clarify in a SAE
followup report
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004201
Page 205 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
City of Buenos
Airesif the subject was
seen in the ER or
MD office when
he experience
biliary colic on
02Nov20
Feb-23-2021
10:44:13
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Opened Clinical - Please
submit the
updated event
term 'worsening
of biliary
lithiasis' to the
SAE
(#2021191154)
report in a safety
update
Feb-23-2021
09:41:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Reissue
d:OpenedClinquery: Thank
you. I see that
there is the AE of
'Biliary colic'
which began on
the same day. I
assume that
referred to
symptoms (pain).
Is there a stop
date for
'Worsening of
biliary lithiasis'?
Thanks.
Feb-22-2021 ACV0PFEINFP6000  auto query Query 1: Answer Changed
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1004202
Page 206 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
14:28:25
(UTC-03:00)
City of Buenos
Aires(autoquery) ed Information
Feb-22-2021
14:28:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Worsening of bili
ary lithiasisChanged
Information
Feb-22-2021
10:12:28
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened Clinquery: Please
modify the term
as 'vesicular
lithiasis' codes to
the bladder rather
than gallbladder.
For medical
history you have
biliary lithiasis
so perhaps
'Worsening of
biliary lithiasis'.
Feb-20-2021
16:13:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Worsening of ves
icular lithiasisInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004203
Page 207 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-20-2021
16:13:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/2/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021
17:22:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Mar/3/2021 18:00New
Information
Feb-20-2021
16:13:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-20-2021
16:13:42
(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;
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004204
Page 208 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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
Mar-01-2021
14:39:26
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Closed Query closed;
will follow for
requested
COVID test
information.
Feb-25-2021
13:17:46
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Answere
dFU SAE form
was sent with
this
information.
Feb-24-2021
05:42:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Feb-23-2021
10:42:51
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Opened Clinical COVID
test status
(yes/no) during
Hosp was not
reported in the
SAE. Please
submit a
follow-up SAE
form
[#2021191154)
to document if
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004205
Page 209 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
COVID testing
was performed
(YES/NO or
info not
available) and if
yes, the date
and results.
Feb-22-2021
14:28:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidat
eFor AE
Worsening of
biliary lithiasis:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Feb-22-2021
00:49:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Deleted Query can be
addressed
internally
Feb-20-2021
16:13:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eFor AE
Worsening of
vesicular
lithiasis:
Response to "Is
the adverse
event serious?"
is 'Yes' but
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004206
Page 210 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
"Serious
Adverse Event
Number" is
blank.
Feb-20-2021
16:13:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious ev
ent associated wi
th congenital ano
maly or birth def
ect?
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?Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004207
Page 211 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
NO
Is this serious ev
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-20-2021
16:13:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-20-2021
16:13:42
(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:Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004208
Page 212 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
OTHER
If Other, specify:
History of gallst
ones
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-20-2021
16:13:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-20-2021
16:13:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-20-2021
16:13:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004209
Page 213 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Mar-12-2021
12:37:54
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Quer
y 1:
Close
dSDB updated
Mar-11-2021
06:57:22
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Quer
y 1:
Reiss
ued:C
andid
atePending SDB update
Mar-10-2021
14:48:10
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Quer
y 1:
Answ
eredFollow-up form is sent to the
sponsor updating bullet 17. Where it
is confirmed that the result of the
adverse event is considered
recovered. SAE end date: MAR 03,
2021, 6:00 p.m.
Mar-10-2021
08:43:50
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Quer
y 1:
Open
edSAE
RECON:AER#2021191154,outcome
was reported as
Recovering/Resolving to Safety DB
however, recorded as
RECOVERED/RESOLVED on AE
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004210
Page 214 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Mar-04-2021
17:22:03
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entr
y:
REC
OVE
RED/
RES
OLV
EDNew Information
Feb-20-2021
16:13:42
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entr
y:
REC
OVE
RIN
G/RE
SOL
VIN
GInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-20-2021
16:13:42
(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
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004211
Page 215 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-24-2021
05:42:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2021191154Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004212
Page 216 of 223
***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: 44441473 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-12-2020
13:39:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-12-2020
13:39:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-12-2020
13:39:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004213
Page 217 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021
15:26:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004214
Page 218 of 223
***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, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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
Jan-19-2021
15:27:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-19-2021
15:27:10
(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.
Jan-19-2021
15:27:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willin
g to return for Vacci
nation 3
Participant is:
eligible and NO
T confirmed to h
ave received onl
y placebo at VacInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004215
Page 219 of 223
***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, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
cination 1/2
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004216
Page 220 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-19-2021
15:27:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-19-2021
15:27:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1004217
Page 221 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-12-2020
13:39:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-23-2020
10:49:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-23-2020
10:48:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-12-2020
13:39:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/12/2020Initial Entry
Sep-23-2020
10:49:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/22/2020Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004218
Page 222 of 223
***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: 44441473 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-23-2020
10:48:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/22/2020Initial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1004219
Page 223 of 223
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441473 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
11:38:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to Enabl
eInitial Entry
090177e196ae2e6c\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1004220