125742 S1 M5 CRF c4591001 1231 12314335

Document text

Page 1 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882625
Page 2 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/26/2020
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882626
Page 3 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Demography
1.Subject ID [12314335]
2.Birth Date: /1955
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882627
Page 4 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882628
Page 5 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882629
Page 6 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/26/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882630
Page 7 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Supraventricular extrasystoles]
Start Date: Apr/20/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Type 2 diabetes]
Start Date: Jun/13/2018
Ongoing: YES
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882631
Page 8 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
2.Weight: [116.65]
3.Unit: kg
4.Height: [182.0]
5.Unit: cm
6.Body Mass Index: [35.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882632
Page 9 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/26/2020
2.Randomization Number: [242304]
3.Randomization Group: [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882633
Page 10 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BPTF59]
5.bSample ID [BPTF5B]
5.cSample ID [BPTF5C]
5.dSample ID [BNV2FG]
5.eSample ID [BNV2FH]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882634
Page 11 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BPT9WS]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882635
Page 12 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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/26/2020 18:50
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
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882636
Page 13 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882637
Page 14 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882638
Page 15 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882639
Page 16 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
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 [BP2FLT]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882640
Page 17 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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/14/2020 12:14
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
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882641
Page 18 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882642
Page 19 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLBX82]
5.bSample ID [BPW65T]
5.cSample ID [BLBX8H]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882643
Page 20 of 116
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882644
Page 21 of 116
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882645
Page 22 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882646
Page 23 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882647
Page 24 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882648
Page 25 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882649
Page 26 of 116
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882650
Page 27 of 116
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882651
Page 28 of 116
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882652
Page 29 of 116
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882653
Page 30 of 116
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882654
Page 31 of 116
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882655
Page 32 of 116
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882656
Page 33 of 116
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882657
Page 34 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882658
Page 35 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Unplanned Assessments
1.Assessments
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882659
Page 36 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882660
Page 37 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882661
Page 38 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882662
Page 39 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882663
Page 40 of 116
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still
ongoing?
6.Toxicity Grade:
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882664
Page 41 of 116
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with
Study Treatment:
11.Was a Concomitant
Medication given?
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882665
Page 42 of 116
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
12.Was a Non-Drug Treatment
given?
13.What was the outcome of
this adverse event?:
14.Did the adverse event cause
the subject to be
discontinued from the
study?
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882666
Page 43 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882667
Page 44 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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[ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882668
Page 45 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882669
Page 46 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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: //
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882670
Page 47 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882671
Page 48 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882672
Page 49 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882673
Page 50 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882674
Page 51 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882675
Page 52 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882676
Page 53 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882677
Page 54 of 116
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882678
Page 55 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882679
Page 56 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882680
Page 57 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882681
Page 58 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882682
Page 59 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882683
Page 60 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882684
Page 61 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882685
Page 62 of 116
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/16/2021
2.Erroneous Visit
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882686
Page 63 of 116
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882687
Page 64 of 116
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/16/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882688
Page 65 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882689
Page 66 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882690
Page 67 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/16/2020
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882691
Page 68 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882692
Page 69 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Jan-21-2021 08:29:01 (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.
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882693
Page 70 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormAug-27-2020 08:37:13 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882694
Page 71 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 Jan-21-2021 08:29:01 (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 Jan-17-2021 18:57:11 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-21-2020 18:29:00 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882695
Page 72 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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.
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882696
Page 73 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-27-2020
08:36:09
(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-27-2020
08:36:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882697
Page 74 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-27-2020
08:36:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Aug/26/2020Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882698
Page 75 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-26-2020
17:36:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12314335Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-26-2020
17:35:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1955Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020
08:36:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020
08:36:32ACV0PFEINFP6000  Data Entry:
HISPANIC OR LATIInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882699
Page 76 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos AiresNO(A) OR OF SPANI
SH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-27-2020
08:36:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882700
Page 77 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020
08:37:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882701
Page 78 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-27-2020
08:38:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020
08:38:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020
08:38:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882702
Page 79 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.a
Date Location User Value Reason
Aug-27-2020
08:39:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical
History T
erm:Supraventri
cular extras
ystoles
Start Dat
e:Apr/20/201
6
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-27-2020
08:39:02
(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-27-2020
08:39:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Supraventricular extra
systolesInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882703
Page 80 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.a Start Date:
Date Location User Value Reason
Aug-27-2020
08:39:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Apr/20/2016Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-27-2020
08:39:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-27-2020
08:39:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Type 2 d
iabetes
Start Date: Jun/13/2
018
Ongoing: YESInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882704
Page 81 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.b Line/MH Number:
Date Location User Value Reason
Aug-27-2020
08:39:36
(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-27-2020
08:39:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type 2 diabetesInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-27-2020
08:39:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jun/13/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-27-2020
08:39:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882705
Page 82 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020
08:40:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-27-2020
08:40:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
116.65Initial Entry
3. Unit:
Date Location User Value Reason
Aug-27-2020
08:40:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-27-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0882706
Page 83 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
08:40:06
(UTC-03:00) City
of Buenos Aires182.0
5. Unit:
Date Location User Value Reason
Aug-27-2020
08:40:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-27-2020
08:40:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35.2Initial Entry
7.a
Date Location User Value Reason
Aug-27-2020
08:40:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:37.2
Temperatu
re Unit:CInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882707
Page 84 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-27-2020
08:40:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-27-2020
08:40:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
37.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-27-2020
08:40:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882708
Page 85 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-27-2020
08:40:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882709
Page 86 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-27-2020
08:40:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-27-2020
08:40:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
242304Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882710
Page 87 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020
08:40:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020
08:40:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
11:56:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-27-2020
12:48:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882711
Page 88 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Aug-27-2020
08:40:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-27-2020
08:40:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
11:56:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPTF5
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
11:56:09ACV0PFEINFP6000  Data Entry:
BPTF59Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882712
Page 89 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos Aires
5.b
Date Location User Value Reason
Aug-28-2020
11:56:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPTF5
BInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020
11:56:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTF5BInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020
11:56:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPTF5
CInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882713
Page 90 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.c Sample ID
Date Location User Value Reason
Aug-28-2020
11:56:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTF5CInitial Entry
5.d
Date Location User Value Reason
Aug-28-2020
19:31:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BNV2F
GInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-28-2020
19:31:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BNV2FGInitial Entry
5.e
Date Location User Value Reason
Aug-28-2020
19:31:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BNV2F
HInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882714
Page 91 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.e Sample ID
Date Location User Value Reason
Aug-28-2020
19:31:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BNV2FHInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882715
Page 92 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020
08:40:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020
08:40:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020
08:47:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-27-2020
08:40:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882716
Page 93 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Aug-27-2020
08:40:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020
08:47:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPT9W
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020
08:47:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPT9WSInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882717
Page 94 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-27-2020
08:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020
08:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020
08:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-27-2020
08:41:01ACV0PFEINFP6000  Data Entry:
Aug/26/2020 18:50Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882718
Page 95 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020
08:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020
08:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-27-2020
08:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-27-2020
08:41:01ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882719
Page 96 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos AiresCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-27-2020
08:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882720
Page 97 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-27-2020
08:41:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882721
Page 98 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020
12:07:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882722
Page 99 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020
12:07:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020
12:07:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.9
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020
12:07:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882723
Page 100 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.a Temperature:
Date Location User Value Reason
Sep-18-2020
12:07:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020
12:07:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020
12:07:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882724
Page 101 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-14-2020
16:13:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-14-2020
16:13:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020
17:38:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-14-2020
16:13:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882725
Page 102 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Sep-14-2020
16:13:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020
17:38:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP2FL
TInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-14-2020
17:38:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP2FLTInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882726
Page 103 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020
12:07:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020
12:07:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020
12:07:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020
12:07:49ACV0PFEINFP6000  Data Entry:
Sep/14/2020 12:14Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882727
Page 104 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020
12:07:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020
12:07:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020
12:07:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020
12:07:49ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882728
Page 105 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos AiresCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-18-2020
12:07:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882729
Page 106 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020
10:25:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882730
Page 107 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020
10:25:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020
10:25:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020
13:34:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-16-2020
10:25:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882731
Page 108 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Oct-16-2020
10:25:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020
13:34:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLBX8
2Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-16-2020
13:34:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLBX82Initial Entry
5.b
Date Location User Value Reason
Oct-16-2020
15:04:05
(UTC-03:00) CityACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I BPW65Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882732
Page 109 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
of Buenos Aires D: T
5.b Sample ID
Date Location User Value Reason
Oct-16-2020
15:04:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPW65TInitial Entry
5.c
Date Location User Value Reason
Oct-16-2020
16:04:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BLBX8
HInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-16-2020
16:04:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLBX8HInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882733
Page 110 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-16-2020
10:25:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020
10:25:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020
10:25:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882734
Page 111 of 116
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-17-2021
18:57:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/16/2021Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882735
Page 112 of 116
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-17-2021
18:57:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing t
o return for Vaccinatio
n 3
Participant is:
eligible and NOT c
onfirmed to have re
ceived only placeb
o at Vaccination 1/
2Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882736
Page 113 of 116
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-17-2021
18:57:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/16/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-17-2021
18:57:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882737
Page 114 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-16-2020
10:25:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-27-2020
08:40:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-27-2020
08:38:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-16-2020
10:25:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/16/2020Initial Entry
Aug-27-2020
08:40:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882738
Page 115 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-27-2020
08:38:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882739
Page 116 of 116
***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: 12314335 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020
18:28:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196d6f286\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882740