125742 S1 M5 CRF c4591001 1231 12315126

Document text

Page 1 of 219
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887411
Page 2 of 219
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/29/2020
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887412
Page 3 of 219
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Demography
1.Subject ID [12315126]
2.Birth Date: /1952
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887413
Page 4 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/29/2020
2.Erroneous Visit
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887414
Page 5 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887415
Page 6 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/29/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887416
Page 7 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Irritable colon]
Start Date: Jan/1/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Smoking]
Start Date: Jan/1/1970
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Skin carcinoma]
Start Date: Jan/1/2015
Ongoing: NO
End Date:
Jan/1/2018
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887417
Page 8 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Congenital degenerative myopia]
Start Date: /1952
Ongoing: YES
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887418
Page 9 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Aug/29/2020
2.Weight: [59.0]
3.Unit: kg
4.Height: [158.0]
5.Unit: cm
6.Body Mass Index: [23.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887419
Page 10 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887420
Page 11 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/29/2020
2.Randomization Number: [245686]
3.Randomization Group: [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887421
Page 12 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/29/2020
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 [BPTT62]
5.bSample ID [BPTT63]
5.cSample ID [BPTT64]
5.dSample ID [BNTXR6]
5.eSample ID [BNTXR7]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887422
Page 13 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/29/2020
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 [BPWTPL]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887423
Page 14 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/29/2020 11:25
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
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887424
Page 15 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887425
Page 16 of 219
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887426
Page 17 of 219
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887427
Page 18 of 219
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/17/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887428
Page 19 of 219
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/17/2020
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 [BPWB71]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887429
Page 20 of 219
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/17/2020 17:32
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
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887430
Page 21 of 219
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887431
Page 22 of 219
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BNTSCW]
5.bSample ID [BNTSDS]
5.cSample ID [BPTHL3]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887432
Page 23 of 219
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/22/2021
2.Erroneous Visit
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887433
Page 24 of 219
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/22/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS1PPG]
5.bSample ID [BP1X0D]
5.cSample ID [BS1PRH]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887434
Page 25 of 219
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887435
Page 26 of 219
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887436
Page 27 of 219
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887437
Page 28 of 219
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887438
Page 29 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887439
Page 30 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/5/2020
2.Date of First Symptom
Started:Oct/3/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/10/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
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
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887440
Page 31 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887441
Page 32 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
 1.Oct/5/2
020 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887442
Page 33 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/5/2020
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: [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887443
Page 34 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_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 a team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887444
Page 35 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPXJTC]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887445
Page 36 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887446
Page 37 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887447
Page 38 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887448
Page 39 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887449
Page 40 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?NO
3.Toxicity Grade: 1
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887450
Page 41 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887451
Page 42 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887452
Page 43 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887453
Page 44 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887454
Page 45 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#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
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887455
Page 46 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887456
Page 47 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887457
Page 48 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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:[ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887458
Page 49 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887459
Page 50 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887460
Page 51 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887461
Page 52 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887462
Page 53 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887463
Page 54 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887464
Page 55 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887465
Page 56 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887466
Page 57 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/05/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887467
Page 58 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/05/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/5/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWDSR]
5.bSample ID [BJ5NM5]
5.cSample ID [BJ5NL9]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887468
Page 59 of 219
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887469
Page 60 of 219
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unplanned Assessments
1.Assessments
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887470
Page 61 of 219
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887471
Page 62 of 219
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887472
Page 63 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887473
Page 64 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887474
Page 65 of 219
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887475
Page 66 of 219
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887476
Page 67 of 219
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887477
Page 68 of 219
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887478
Page 69 of 219
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887479
Page 70 of 219
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887480
Page 71 of 219
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887481
Page 72 of 219
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887482
Page 73 of 219
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887483
Page 74 of 219
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887484
Page 75 of 219
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887485
Page 76 of 219
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887486
Page 77 of 219
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  In situ squamous
cell carcinoma Jan/15/202
1 08:00 YES  Repeating
Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887487
Page 78 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[In situ squamous cell carcinoma]
4.Start Date Time: Jan/15/2021 08:00
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887488
Page 79 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).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?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887489
Page 80 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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:
[Risk factors (previous history of skin cancer, smoking,
sun exposure)]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT 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[2021320159]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887490
Page 81 of 219
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887491
Page 82 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887492
Page 83 of 219
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887493
Page 84 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887494
Page 85 of 219
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887495
Page 86 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887496
Page 87 of 219
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887497
Page 88 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887498
Page 89 of 219
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887499
Page 90 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887500
Page 91 of 219
***Confidential***
 
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887501
Page 92 of 219
***Confidential***
 
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887502
Page 93 of 219
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/29/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887503
Page 94 of 219
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887504
Page 95 of 219
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887505
Page 96 of 219
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/20/2020
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887506
Page 97 of 219
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887507
Page 98 of 219
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-24-2021 17:00:44 (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.
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887508
Page 99 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-29-2020 18:05:52
(UTC-03:00) City of Buenos AiresNot Applicable
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887509
Page 100 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-29-2020 18:11:11
(UTC-03:00) City of Buenos AiresNot Applicable
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887510
Page 101 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Aug-29-2020 18:11:11 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887511
Page 102 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Aug-29-2020 18:11:11 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887512
Page 103 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Aug-29-2020 18:11:11 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887513
Page 104 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Aug-29-2020 18:11:11 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887514
Page 105 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
5Aug-29-2020 18:11:11 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887515
Page 106 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6.aAug-29-2020 18:11:11 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887516
Page 107 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6.aAug-29-2020 18:11:11 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887517
Page 108 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6.aAug-29-2020 18:11:11 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887518
Page 109 of 219
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-24-2021 17:00:44 (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 Mar-22-2021 17:02:37 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-01-2021 17:53:54 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887519
Page 110 of 219
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-29-2021 15:53:15 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-15-2020 18:17:21 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887520
Page 111 of 219
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, , verify that all case report form pages
accurately display the results of the examinations, tests, evaluations and treatments performed on
this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Nov-15-2020 12:44:30 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-06-2020 19:05:00 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887521
Page 112 of 219
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Nov-06-2020 10:43:36 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Nov-05-2020 21:41:57 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887522
Page 113 of 219
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Nov-05-2020 14:56:38 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-26-2020 18:29:32 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887523
Page 114 of 219
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887524
Page 115 of 219
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-29-2020
18:05:16
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-29-2020
18:05:16
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887525
Page 116 of 219
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-29-2020
18:05:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Co
nsent Obtained
Aug/29/2020Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887526
Page 117 of 219
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-29-2020
10:17:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12315126Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-29-2020
10:17:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1952Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-29-2020
18:05:30
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887527
Page 118 of 219
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-29-2020
18:05:30
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LA
TINO(A) OR OF
SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-29-2020
18:05:30
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887528
Page 119 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-29-2020
18:05:46
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/29/2020Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887529
Page 120 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-29-2020
18:06:03
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-29-2020
18:06:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-29-2020
18:06:03
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887530
Page 121 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.a
Date Location User Value Reason
Aug-29-2020
18:06:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Irritable
colon
Start Date: Jan/1/2
000
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-29-2020
18:06:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-29-2020
18:06:39
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Data Entry:
Irritable colonInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887531
Page 122 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aires
1.a Start Date:
Date Location User Value Reason
Aug-29-2020
18:06:39
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Jan/1/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-29-2020
18:06:39
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-29-2020
18:07:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:Smoki
ng
Start Date: Jan/1/
1970Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887532
Page 123 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Ongoing: YES
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887533
Page 124 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.b Line/MH Number:
Date Location User Value Reason
Aug-29-2020
18:07:35
(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
Aug-29-2020
18:07:35
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
SmokingInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-29-2020
18:07:35
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Jan/1/1970Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887534
Page 125 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-29-2020
18:07:35
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-29-2020
18:08:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Skin carc
inoma
Start Date: Jan/1/20
15
Ongoing: NO
End Da
te:
Jan/1/
2018Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887535
Page 126 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.c Line/MH Number:
Date Location User Value Reason
Aug-29-2020
18:08:09
(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
Aug-29-2020
18:08:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Skin carcinomaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-29-2020
18:08:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Jan/1/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887536
Page 127 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-29-2020
18:08:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/1/2018Initial Entry
1.d
Date Location User Value Reason
Aug-29-2020
18:09:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History
Term:Congenital
degenerativ
e myopia
Start Da
te:/1952
Ongoing
:YESInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887537
Page 128 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.d Line/MH Number:
Date Location User Value Reason
Aug-29-2020
18:09:27
(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
Aug-29-2020
18:09:27
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Congenital degene
rative myopiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-29-2020
18:09:27
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
/1952Initial Entry
1.d Ongoing:
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887538
Page 129 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-29-2020
18:09:27
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887539
Page 130 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Aug-29-2020
18:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/29/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-29-2020
18:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
59.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-29-2020
18:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887540
Page 131 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Aug-29-2020
18:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
158.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-29-2020
18:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-29-2020
18:09:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.6Initial Entry
7.a
Date Location User Value Reason
Aug-29-2020
18:09:49
(UTC-03:00)ACV0PFEINFP6000  Data Entry:
Record I 1Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887541
Page 132 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
City of Buenos
Airesdentifier:
:
Temperat
ure:36.6
Temperat
ure Unit:C
Temperat
ure Locat
ion::ORAL
CAVI
TY
7.a Record Identifier:
Date Location User Value Reason
Aug-29-2020
18:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-29-2020
18:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
36.6Initial Entry
7.a Unit:
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887542
Page 133 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Aug-29-2020
18:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-29-2020
18:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887543
Page 134 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-29-2020
18:11:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-29-2020
18:11:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-29-2020
18:11:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887544
Page 135 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Aug-29-2020
18:11:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-29-2020
18:11:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-29-2020
18:11:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sponsor-
Defined I
dentifier:Not A
pplica
ble
Test:: Not A
pplica
ble
Result:: Not A
pplica
bleInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887545
Page 136 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Not Done:
:Not A
pplica
ble
6.a Sponsor ID:
Date Location User Value Reason
Aug-29-2020
18:11:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Aug-29-2020
18:11:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Aug-29-2020
18:11:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887546
Page 137 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
6.a Not Done:
Date Location User Value Reason
Aug-29-2020
18:11:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887547
Page 138 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-29-2020
18:11:33
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/29/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-29-2020
18:11:33
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
245686Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887548
Page 139 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-29-2020
18:11:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-29-2020
18:11:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020
12:03:32
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-29-2020
18:11:39
(UTC-03:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887549
Page 140 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
City of Buenos
Airesno barcodes
are entered.
Please review
and correct as
appropriate.
Aug-29-2020
18:11:39
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Aug/29/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020
12:03:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPTT6
2Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020
12:03:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTT62Initial Entry
5.b
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887550
Page 141 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Aug-31-2020
12:03:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPTT6
3Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-31-2020
12:03:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTT63Initial Entry
5.c
Date Location User Value Reason
Aug-31-2020
12:03:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPTT6
4Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-31-2020
12:03:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTT64Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887551
Page 142 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.d
Date Location User Value Reason
Aug-31-2020
13:32:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
Sample I
D:BNTXR
6Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-31-2020
13:32:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
BNTXR6Initial Entry
5.e
Date Location User Value Reason
Aug-31-2020
13:32:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
Sample I
D:BNTXR
7Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887552
Page 143 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.e Sample ID
Date Location User Value Reason
Aug-31-2020
13:32:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
BNTXR7Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887553
Page 144 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-29-2020
18:11:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-29-2020
18:11:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-30-2020
13:59:34
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-29-2020
18:11:46
(UTC-03:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887554
Page 145 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
City of Buenos
Airesno barcodes
are entered.
Please review
and correct as
appropriate.
Aug-29-2020
18:11:46
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Aug/29/2020Initial Entry
5.a
Date Location User Value Reason
Aug-30-2020
13:59:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPWT
PLInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-30-2020
13:59:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPWTPLInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887555
Page 146 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-29-2020
18:12:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-29-2020
18:12:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-29-2020
18:12:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887556
Page 147 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-29-2020
18:12:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/29/2020 11:2
5Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-29-2020
18:12:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-29-2020
18:12:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-29-2020
18:12:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887557
Page 148 of 219
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-29-2020
18:12:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-29-2020
18:12:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887558
Page 149 of 219
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-29-2020
18:12:10
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGE
NICITY E-DIAR
Y NOT COLLEC
TED FOR THIS S
UBJECTInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887559
Page 150 of 219
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020
09:04:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-13-2020
12:06:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answer
edcov ill visit
triggered on
oct 5
Oct-07-2020
08:39:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened As per Illness
ediary records,
subject
reported "Yes"
for the
question
"Have you
experienced
any of the
following?”
for the
COVID-19
symptoms or
diagnosis on
05OCT2020.
But there is no
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887560
Page 151 of 219
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
COVID Illness
visit reported
in the
database.
Please clarify.
Sep-17-2020
18:55:34
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887561
Page 152 of 219
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020
18:55:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020
18:55:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record I
dentifier:
:1
Temperat
ure:37.1
Temperat
ure Unit:C
Temperat
ure Locat
ion::ORAL
CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887562
Page 153 of 219
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-17-2020
18:55:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-17-2020
18:55:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
37.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-17-2020
18:55:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-17-2020
18:55:40
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887563
Page 154 of 219
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aires
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887564
Page 155 of 219
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-17-2020
18:55:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-17-2020
18:55:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-17-2020
18:55:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887565
Page 156 of 219
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-17-2020
18:55:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-17-2020
18:55:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-15-2020
12:44:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor
-Define
d Identi
fier:113
Test:: Choriogo
nadotropi
n Beta_P
X113
Result::
Not Don
e::NOT DO
NETranscription
Error
Sep-17-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887566
Page 157 of 219
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
18:55:48
(UTC-03:00) City
of Buenos Aires(autocalc) Sponsor
-Define
d Identi
fier:113
Test:: Choriogo
nadotropi
n Beta_P
X113
Result:: NEGATI
VE
Not Don
e::
6.a Sponsor ID:
Date Location User Value Reason
Sep-17-2020
18:55:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-17-2020
18:55:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropi
n Beta_PX113Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887567
Page 158 of 219
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
6.a Result:
Date Location User Value Reason
Nov-15-2020
12:44:30
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry: Transcription
Error
Sep-17-2020
18:55:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
6.a Not Done:
Date Location User Value Reason
Nov-15-2020
12:44:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONETranscription
Error
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887568
Page 159 of 219
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020
18:55:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020
18:55:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020
19:45:10
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-17-2020
18:55:55
(UTC-03:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887569
Page 160 of 219
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
City of Buenos
Airesno barcodes
are entered.
Please review
and correct as
appropriate.
Sep-17-2020
18:55:55
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
19:45:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BPWB7
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
19:45:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPWB71Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887570
Page 161 of 219
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-17-2020
18:56:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020
18:56:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020
18:56:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887571
Page 162 of 219
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-17-2020
18:56:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020 17:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020
18:56:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-17-2020
18:56:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-17-2020
18:56:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887572
Page 163 of 219
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-17-2020
18:56:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-17-2020
18:56:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887573
Page 164 of 219
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020
18:19:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887574
Page 165 of 219
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020
18:19:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020
18:19:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020
18:53:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-20-2020
18:19:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887575
Page 166 of 219
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
are entered.
Please review
and correct as
appropriate.
Oct-20-2020
18:19:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020
18:53:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BNTSC
WInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020
18:53:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTSCWInitial Entry
5.b
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887576
Page 167 of 219
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-21-2020
09:05:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BNTSD
SInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020
09:05:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTSDSInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020
09:48:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPTHL
3Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020
09:48:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTHL3Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887577
Page 168 of 219
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-22-2021
17:02:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/22/2021Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887578
Page 169 of 219
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-22-2021
17:02:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-22-2021
17:02:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-23-2021
10:51:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-22-2021
17:02:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887579
Page 170 of 219
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
are entered.
Please review
and correct as
appropriate.
Mar-22-2021
17:02:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/22/2021Initial Entry
5.a
Date Location User Value Reason
Mar-23-2021
10:51:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BS1PP
GInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-23-2021
10:51:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS1PPGInitial Entry
5.b
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887580
Page 171 of 219
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Mar-23-2021
10:55:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BP1X0
DInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-23-2021
10:55:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BP1X0DInitial Entry
5.c
Date Location User Value Reason
Mar-23-2021
13:01:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BS1PR
HInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-23-2021
13:01:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BS1PRHInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887581
Page 172 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020
11:14:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Oct-07-2020
11:10:33
(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.
Oct-07-2020
11:10:33
(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
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887582
Page 173 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Swab Self and
Nasal Swab
are missing.
Please review
and update as
appropriate.
Oct-07-2020
11:10:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-07-2020
11:10:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887583
Page 174 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/3/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-14-2020
10:11:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Sympt
om Resolved:
Oct/10/2020New
Information
Oct-07-2020
11:12:15ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887584
Page 175 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City
of Buenos Aires
4.a
Date Location User Value Reason
Oct-07-2020
11:12:15
(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
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887585
Page 176 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED
COUGH
Sympt
om Pre
sent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-07-2020
11:12:15
(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
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Oct-07-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0887586
Page 177 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
11:12:15
(UTC-03:00) City
of Buenos AiresSymp
toms:NEW OR INC
REASED SH
ORTNESS OF
BREATH
Symp
tom P
resen
t:NO
4.c Symptoms:
Date Location User Value Reason
Oct-07-2020
11:12:15
(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
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-07-2020
11:12:15ACV0PFEINFP6000  Data Entry:
Symptoms: CHILInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887587
Page 178 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City
of Buenos AiresLS
Symptom Pr
esent:NO
4.d Symptoms:
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE PA
INInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887588
Page 179 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sympt
om Pr
esent:NO
4.e Symptoms:
Date Location User Value Reason
Oct-07-2020
11:12:15
(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
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pre
sent:NOInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887589
Page 180 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4.f Symptoms:
Date Location User Value Reason
Oct-07-2020
11:12:15
(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
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THROA
T
Sympt
om Pr
esent:NOInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887590
Page 181 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4.g Symptoms:
Date Location User Value Reason
Oct-07-2020
11:12:15
(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
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARR
HEA
Symptom P
resent:NOInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887591
Page 182 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4.h Symptoms:
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMIT
ING
Symptom P
resent:NOInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887592
Page 183 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4.i Symptoms:
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-07-2020
11:12:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887593
Page 184 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Oct-07-2020
11:13:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887594
Page 185 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-07-2020
11:13:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-10-2020
06:47:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Sandip
Namdeorao
SuryawanshiQuery 1: Closed Response
satisfies
query
Oct-09-2020
12:27:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Answered Data item #3
updated
Oct-08-2020
07:20:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: The
response for
Data item#3
is missing.
Kindly
review and
update.
Oct-07-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0887595
Page 186 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
11:13:45
(UTC-03:00) City
of Buenos AiresSWABBED MATE
RIAL
3. Specimen Collection Location:
Date Location User Value Reason
Oct-09-2020
12:26:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-07-2020
11:13:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Oct-07-2020
11:13:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGN
OSTIC TESTInitial Entry
6. Trade Name:
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887596
Page 187 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Oct-07-2020
11:13:45
(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
Oct-07-2020
11:13:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887597
Page 188 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020
11:14:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020
11:14:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020
11:14:09
(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
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887598
Page 189 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-07-2020
11:14:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample collected by a
team physicianInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887599
Page 190 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020
11:14:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020
11:14:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020
19:23:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-07-2020
11:14:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887600
Page 191 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
are entered.
Please review
and correct as
appropriate.
Oct-07-2020
11:14:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020
19:23:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPXJT
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020
19:23:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPXJTCInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887601
Page 192 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.a
Date Location User Value Reason
Oct-07-2020
11:16:03
(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
Oct-07-2020
11:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-07-2020
11:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887602
Page 193 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.b
Date Location User Value Reason
Oct-07-2020
11:16:03
(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
Oct-07-2020
11:16:03
(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
Oct-07-2020
11:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887603
Page 194 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-07-2020
11:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of P
ractitione
r:PRIMAR
Y CARE
PHYSICI
AN
Occurren
ce of Visit
s or Cont
acts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-07-2020
11:16:03
(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
Oct-07-2020
11:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887604
Page 195 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-07-2020
11:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:URGE
NT C
ARE
Occurrence
of Visits or
Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-07-2020
11:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-07-2020
11:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-07-2020
11:16:03
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Type of P
ractitioneTELEPH
ONE COInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887605
Page 196 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
of Buenos Aires r: NSULTA
TION
Occurren
ce of Visit
s or Cont
acts:NO
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-07-2020
11:16:03
(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
Oct-07-2020
11:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-07-2020
11:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:OT
HE
RInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887606
Page 197 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Occurrence of
Visits or Conta
cts:NO
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-07-2020
11:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-07-2020
11:16:03
(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
Oct-07-2020
11:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887607
Page 198 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-07-2020
11:15:48
(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
Oct-07-2020
11:15:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-07-2020
11:15:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887608
Page 199 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/05/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020
14:56:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/5/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-05-2020
14:56:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887609
Page 200 of 219
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/05/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-05-2020
14:56:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-05-2020
14:56:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020
10:43:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-05-2020
20:21:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: 'Sample
Collected?' is
Yes, however,
no barcodes
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887610
Page 201 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/05/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
are entered.
Please review
and correct as
appropriate.
Nov-05-2020
14:56:46
(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-05-2020
14:56:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
Nov-06-2020
10:43:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPWDS
RInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887611
Page 202 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/05/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Nov-06-2020
10:43:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPWDSRInitial Entry
5.b
Date Location User Value Reason
Nov-06-2020
10:57:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BJ5NM
5Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-06-2020
10:57:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BJ5NM5Initial Entry
5.c
Date Location User Value Reason
Nov-06-2020
11:19:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BJ5NL
9Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887612
Page 203 of 219
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/05/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.c Sample ID
Date Location User Value Reason
Nov-06-2020
11:19:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BJ5NL9Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887613
Page 204 of 219
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-20-2020
18:19:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-20-2020
18:19:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-20-2020
18:19:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887614
Page 205 of 219
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-29-2021
15:53:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/29/2021Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887615
Page 206 of 219
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-29-2021
15:53:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-29-2021
15:53:30
(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-29-2021
15:53:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willin
g to return for Vacci
nation 3
Participant is:
eligible and NOT
confirmed to hav
e received only pInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887616
Page 207 of 219
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
lacebo at Vaccina
tion 1/2
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887617
Page 208 of 219
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887618
Page 209 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category:
Date Location User Value Reason
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-23-2021
13:35:47
(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
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
In situ squamous cell c
arcinomaInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887619
Page 210 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/15/2021 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887620
Page 211 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Mar-24-2021
06:23:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE In situ
squamous cell
carcinoma:
Response to
"Is the adverse
event
serious?" is
'Yes' but
"Serious
Adverse Event
Number" is
blank.
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event
associated with con
genital anomaly or
birth defect?
NO
Did this serious eve
nt result in death?
NO
Did this serious eveInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887621
Page 212 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
nt require or prolon
g hospitalization?
NO
Did this serious eve
nt result in persisten
t or significant disab
ility/incapacity?
NO
Is this serious event
life threatening?
NO
Other medically im
portant serious even
t
YES
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
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887622
Page 213 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:
Risk factors (pre
vious history of s
kin cancer, smok
ing, sun exposur
e)Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887623
Page 214 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/N
OT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-23-2021
13:35:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887624
Page 215 of 219
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Mar-24-2021
06:23:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2021320159Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887625
Page 216 of 219
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-29-2021
15:53:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/29/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-29-2021
15:53:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887626
Page 217 of 219
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-20-2020
18:19:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-29-2020
18:11:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-29-2020
18:06:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-20-2020
18:19:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
Aug-29-2020
18:11:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/29/2020Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887627
Page 218 of 219
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-29-2020
18:06:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/29/2020Initial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887628
Page 219 of 219
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12315126 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-26-2020
18:29:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f08\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887629