125742 S1 M5 CRF c4591001 1231 12315498

Document text

Page 1 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889815
Page 2 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/30/2020
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889816
Page 3 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Demography
1.Subject ID [12315498]
2.Birth Date: /1964
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889817
Page 4 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/30/2020
2.Erroneous Visit
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889818
Page 5 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889819
Page 6 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889820
Page 7 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889821
Page 8 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Aug/30/2020
2.Weight: [95.0]
3.Unit: kg
4.Height: [177.0]
5.Unit: cm
6.Body Mass Index: [30.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889822
Page 9 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/30/2020
2.Randomization Number: [74489]
3.Randomization Group: [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889823
Page 10 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/30/2020
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 [BNV3CF]
5.bSample ID [BNV3CG]
5.cSample ID [BPTD99]
5.dSample ID [BPTD9B]
5.eSample ID [BPTD9C]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889824
Page 11 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/30/2020
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 [BP25KW]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889825
Page 12 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/30/2020 12:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889826
Page 13 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889827
Page 14 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/19/2020
2.Erroneous Visit
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889828
Page 15 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Sep/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889829
Page 16 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/19/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWDZG]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889830
Page 17 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/19/2020 11:56
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
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889831
Page 18 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889832
Page 19 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNTWDT]
5.bSample ID [BPW5R4]
5.cSample ID [BNTWDG]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889833
Page 20 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889834
Page 21 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889835
Page 22 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889836
Page 23 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889837
Page 24 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889838
Page 25 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889839
Page 26 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889840
Page 27 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889841
Page 28 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889842
Page 29 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unplanned Assessments
1.Assessments
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889843
Page 30 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889844
Page 31 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889845
Page 32 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889846
Page 33 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889847
Page 34 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889848
Page 35 of 159
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889849
Page 36 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vaccination
1.Was there a temporary delay
of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889850
Page 37 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889851
Page 38 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889852
Page 39 of 159
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/16/2021
2.Erroneous Visit
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889853
Page 40 of 159
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response -
Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889854
Page 41 of 159
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889855
Page 42 of 159
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/26/2021
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889856
Page 43 of 159
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889857
Page 44 of 159
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/26/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889858
Page 45 of 159
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRYW7Y]
5.bSample ID [BRYW59]
5.cSample ID [BPW6DB]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889859
Page 46 of 159
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWFDV]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889860
Page 47 of 159
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/26/2021 11:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889861
Page 48 of 159
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889862
Page 49 of 159
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/17/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHXH88]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889863
Page 50 of 159
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/17/2021 11:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889864
Page 51 of 159
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/17/2021
2.Erroneous Visit
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889865
Page 52 of 159
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/17/2021
3.Comments: [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889866
Page 53 of 159
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889867
Page 54 of 159
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889868
Page 55 of 159
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889869
Page 56 of 159
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889870
Page 57 of 159
***Confidential***
 
Header Text: C4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/17/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889871
Page 58 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#CategoryAE Ident
ifierAdverse E
ventStart DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Nephrolith
iasis Dec/5/2020
22:00 NO
End Date Time:
Jan/21/2021 UNK:UN
K
 Repeating
Pages
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889872
Page 59 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Nephrolithiasis]
4.Start Date Time: Dec/5/2020 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/21/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889873
Page 60 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889874
Page 61 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020489306]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889875
Page 62 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication Er
rors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889876
Page 63 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889877
Page 64 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889878
Page 65 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade
or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889879
Page 66 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889880
Page 67 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade
or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889881
Page 68 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Catego
ryTreatment Iden
tifierCon Non-Drug Treatments Pr
e-specifiedTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889882
Page 69 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889883
Page 70 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889884
Page 71 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889885
Page 72 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/16/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889886
Page 73 of 159
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date
:Not Applicable
//Comments
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889887
Page 74 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889888
Page 75 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/22/2020
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889889
Page 76 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889890
Page 77 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Fernando
Polack Approved Mar-18-2021 11:26:56 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889891
Page 78 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-30-2020 14:43:05 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889892
Page 79 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-30-2020 14:43:33 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889893
Page 80 of 159
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormJan-26-2021 12:20:13 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889894
Page 81 of 159
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormJan-19-2021 15:36:44 (UTC-03:00)
City of Buenos AiresSantiago
CorradettiNot Applicable
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889895
Page 82 of 159
***Confidential***
Header Text: C4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Jan-19-2021 15:36:44 (UTC-03:00)
City of Buenos AiresSantiago
CorradettiNot Applicable
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889896
Page 83 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Fernando
Polack Approved Mar-18-2021 11:26:56 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
 N/A Mar-17-2021 14:10:57 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Yanina
Rivera Approved Feb-18-2021 15:08:33 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889897
Page 84 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, YaninaRivera, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
 N/A Feb-17-2021 12:30:09 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-29-2021 15:00:47 (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.
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889898
Page 85 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
 N/A Jan-26-2021 12:19:52 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-21-2021 16:21:04 (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 Dec-10-2020 13:58:42 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-26-2020 19:56:31 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (6)
(b) 
(6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889899
Page 86 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889900
Page 87 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-30-2020
14:42:22
(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-30-2020
14:42:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889901
Page 88 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-30-2020
14:42:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Aug/30/2020Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889902
Page 89 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-30-2020
12:08:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12315498Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-30-2020
12:08:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1964Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-30-2020
14:42:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-30-2020
14:42:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATIN
O(A) OR OF SPANISH
ORIGINInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889903
Page 90 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-30-2020
14:42:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889904
Page 91 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-30-2020
14:42:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/30/2020Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889905
Page 92 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-30-2020
14:43:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-30-2020
14:43:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-30-2020
14:43:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889906
Page 93 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Aug-30-2020
14:44:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-30-2020
14:44:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
95.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-30-2020
14:44:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-30-2020
14:44:07
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
177.0Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889907
Page 94 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
of Buenos Aires
5. Unit:
Date Location User Value Reason
Aug-30-2020
14:44:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-30-2020
14:44:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.3Initial Entry
7.a
Date Location User Value Reason
Aug-30-2020
14:44:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Iden
tifier::1
Temperature
:36.9
Temperature
Unit:C
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889908
Page 95 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Aug-30-2020
14:44:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-30-2020
14:44:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-30-2020
14:44:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-30-2020
14:44:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889909
Page 96 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-30-2020
14:44:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-30-2020
14:44:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
74489Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889910
Page 97 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-30-2020
14:44:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-30-2020
14:44:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020
17:28:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-30-2020
14:44:30
(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
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889911
Page 98 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
appropriate.
Aug-30-2020
14:44:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/30/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020
17:28:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID
:BNV3C
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020
17:28:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BNV3CFInitial Entry
5.b
Date Location User Value Reason
Aug-31-2020
17:28:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID
:BNV3C
GInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889912
Page 99 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.b Sample ID
Date Location User Value Reason
Aug-31-2020
17:28:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BNV3CGInitial Entry
5.c
Date Location User Value Reason
Aug-31-2020
18:30:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BPTD99Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-31-2020
18:30:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPTD99Initial Entry
5.d
Date Location User Value Reason
Aug-31-2020
18:30:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID
:BPTD9
BInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889913
Page 100 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.d Sample ID
Date Location User Value Reason
Aug-31-2020
18:30:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPTD9BInitial Entry
5.e
Date Location User Value Reason
Aug-31-2020
18:30:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID
:BPTD9
CInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-31-2020
18:30:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPTD9CInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889914
Page 101 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-30-2020
14:44:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-30-2020
14:44:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020
09:34:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-30-2020
14:44:37
(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
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889915
Page 102 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
appropriate.
Aug-30-2020
14:44:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/30/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020
09:34:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP25KWInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020
09:34:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP25KWInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889916
Page 103 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-30-2020
14:44:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-30-2020
14:44:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-30-2020
14:44:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-30-2020
14:44:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/30/2020 12:52Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889917
Page 104 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5. Anatomical Location:
Date Location User Value Reason
Aug-30-2020
14:44:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-30-2020
14:44:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-30-2020
14:44:58
(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-30-2020
14:44:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEC
IFIED OBSERVATION
PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889918
Page 105 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
investigational product administration?
Date Location User Value Reason
Aug-30-2020
14:44:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889919
Page 106 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-30-2020
14:45:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICI
TY E-DIARY NOT CO
LLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889920
Page 107 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-19-2020
14:21:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/19/2020Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889921
Page 108 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Sep-19-2020
14:21:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/19/2020Initial Entry
2.a
Date Location User Value Reason
Sep-19-2020
14:21:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Record Ide
ntifier::1
Temperatur
e:36.9
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-19-2020
14:21:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
1Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889922
Page 109 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
2.a Temperature:
Date Location User Value Reason
Sep-19-2020
14:21:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-19-2020
14:21:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-19-2020
14:21:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
ORAL CAVITYInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889923
Page 110 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-19-2020
14:21:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-19-2020
14:21:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-19-2020
14:36:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-19-2020
14:21:32
(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
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889924
Page 111 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
appropriate.
Sep-19-2020
14:21:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Date of Collection:
Sep/19/2020Initial Entry
5.a
Date Location User Value Reason
Sep-19-2020
14:36:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPWDZ
GInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-19-2020
14:36:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPWDZGInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889925
Page 112 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-19-2020
14:21:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-19-2020
14:21:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-19-2020
14:21:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-19-2020
14:21:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/19/2020 11:56Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889926
Page 113 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5. Anatomical Location:
Date Location User Value Reason
Sep-19-2020
14:21:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-19-2020
14:21:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-19-2020
14:21:49
(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-19-2020
14:21:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEC
IFIED OBSERVATION
PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889927
Page 114 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
investigational product administration?
Date Location User Value Reason
Sep-19-2020
14:21:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889928
Page 115 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-22-2020
12:11:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889929
Page 116 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020
12:11:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020
12:11:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020
14:48:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-22-2020
12:11:50
(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
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889930
Page 117 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
appropriate.
Oct-22-2020
12:11:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020
14:48:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BNTWD
TInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-22-2020
14:48:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTWDTInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020
15:03:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPW5R4Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889931
Page 118 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.b Sample ID
Date Location User Value Reason
Oct-22-2020
15:03:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPW5R4Initial Entry
5.c
Date Location User Value Reason
Oct-22-2020
15:16:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BNTWD
GInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020
15:16:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTWDGInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889932
Page 119 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-23-2020
11:19:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-23-2020
11:19:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-23-2020
11:19:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889933
Page 120 of 159
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-16-2021
20:17:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/16/2021Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889934
Page 121 of 159
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-16-2021
20:19:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-16-2021
20:18:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-16-2021
20:18:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing t
o return for Vaccinatio
n 3
Participant is:
eligible per local/n
ational recommend
ations and confirm
ed to have received
only placebo at VacInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889935
Page 122 of 159
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
cination 1/2
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889936
Page 123 of 159
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-26-2021
12:19:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/26/2021Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889937
Page 124 of 159
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-26-2021
12:20:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Jan/26/2021Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889938
Page 125 of 159
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-26-2021
12:20:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/26/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-26-2021
12:20:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-26-2021
12:20:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889939
Page 126 of 159
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-26-2021
12:20:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-26-2021
12:20:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021
08:44:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-27-2021
08:07:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889940
Page 127 of 159
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
appropriate.
Jan-26-2021
12:20:58
(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.
Jan-26-2021
12:20:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/26/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021
08:44:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BRYW7
YInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-27-2021
08:44:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRYW7YInitial Entry
5.b
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889941
Page 128 of 159
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Jan-27-2021
10:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BRYW5
9Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-27-2021
10:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRYW59Initial Entry
5.c
Date Location User Value Reason
Jan-27-2021
10:31:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPW6D
BInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-27-2021
10:31:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPW6DBInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889942
Page 129 of 159
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-26-2021
12:21:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-26-2021
12:21:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021
11:19:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-27-2021
08:07:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889943
Page 130 of 159
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
appropriate.
Jan-26-2021
12:21:08
(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.
Jan-26-2021
12:21:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/26/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021
11:19:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPWFD
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-27-2021
11:19:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPWFDVInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889944
Page 131 of 159
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-26-2021
12:21:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-26-2021
12:21:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-26-2021
12:21:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-26-2021
12:21:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/26/2021 11:22Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889945
Page 132 of 159
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5. Anatomical Location:
Date Location User Value Reason
Jan-26-2021
12:21:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-26-2021
12:21:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Jan-26-2021
12:21:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-26-2021
12:21:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889946
Page 133 of 159
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Jan-26-2021
12:21:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-26-2021
12:21:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Jan-26-2021
12:21:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889947
Page 134 of 159
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-17-2021
12:30:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/17/2021Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889948
Page 135 of 159
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-17-2021
12:30:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-17-2021
12:30:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-18-2021
09:51:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-18-2021
09:43:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889949
Page 136 of 159
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
appropriate.
Feb-17-2021
12:30:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
appropriate.
Feb-17-2021
12:30:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/17/2021Initial Entry
5.a
Date Location User Value Reason
Feb-18-2021
09:51:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID
:BHXH8
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-18-2021
09:51:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BHXH88Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889950
Page 137 of 159
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-17-2021
12:30:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-17-2021
12:30:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-17-2021
12:30:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-17-2021
12:30:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/17/2021 11:25Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889951
Page 138 of 159
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5. Anatomical Location:
Date Location User Value Reason
Feb-17-2021
12:30:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-17-2021
12:30:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Feb-17-2021
12:30:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-17-2021
12:30:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889952
Page 139 of 159
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Feb-17-2021
12:30:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-17-2021
12:30:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-17-2021
12:30:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889953
Page 140 of 159
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-17-2021
14:10:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/17/2021Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889954
Page 141 of 159
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-17-2021
14:11:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-17-2021
14:11:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Mar/17/2021Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889955
Page 142 of 159
***Confidential***
 
Header Text: C4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-17-2021
14:12:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/17/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-17-2021
14:12:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREAT
MENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-17-2021
14:12:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889956
Page 143 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Dec-10-2020
13:58:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889957
Page 144 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category:
Date Location User Value Reason
Dec-10-2020
13:58:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-10-2020
13:58:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-12-2020
10:18:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NephrolithiasisNew
Information
Dec-10-2020
13:58:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
DiverticulitisInitial Entry
4. Start Date Time:
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889958
Page 145 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Dec-10-2020
13:58:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/5/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-27-2021
10:42:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/21/2021 UNK:U
NKNew
Information
Dec-10-2020
13:58:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-10-2020
13:58:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889959
Page 146 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical
event (i.e. may jeopardize subject and may require medical/surgical intervention to prevent above
outcomes).
Date Location User Value Reason
Dec-17-2020
14:59:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Dec-16-2020
17:53:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Answered On 12/12/2020 a
follow-up form
for the adverse
event was sent.
Dec-15-2020
23:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Reissued:O
penedClinical – Thank
you. If NO
hospital COVID
test was
performed is
known, please
submit this
information on a
follow-up SAE
form, as
pertinent
information for
this trial.
Dec-12-2020
10:23:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Answered Covid test was
not performed
because the
adverse event is
not associated
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889960
Page 147 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
with Covid
disease, in
addition the
patient did not
present
symptoms of
Covid disease.
Thank you.
Dec-11-2020
15:18:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Opened Clinical COVID
test status
(yes/no) during
Hosp was not
reported in the
SAE. Please
submit a
follow-up SAE
form
[#2020489306]
to document if
COVID testing
was performed
(YES/NO or
info not
available) and if
yes, the date and
results.
Dec-11-2020
07:35:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-10-2020
13:58:42
(UTC-03:00) CityACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Diverticulitis:
Response to "Is
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889961
Page 148 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
of Buenos Aires the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Dec-10-2020
13:58:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious even
t associated with c
ongenital anomaly
or birth defect?
NO
Did this serious ev
ent result in death?
NO
Did this serious ev
ent require or prolo
ng hospitalization?
YES
Did this serious ev
ent result in persist
ent or significant d
isability/incapacity
?
NOInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889962
Page 149 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Is this serious even
t life threatening?
NO
Other medically i
mportant serious e
vent
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-10-2020
13:58:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-10-2020
13:58:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study
treatment(s), this event
is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889963
Page 150 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-10-2020
13:58:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-10-2020
13:58:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-10-2020
13:58:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Jan-27-2021
10:42:53
(UTC-03:00)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Clo
sedClose Auto Query
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889964
Page 151 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
City of
Buenos
Aires
Jan-27-2021
10:42:53
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
REC
OVE
RED/
RESO
LVE
DNew Information
Jan-27-2021
10:42:42
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
2: Op
enedFor AE Nephrolithiasis: Response to
"What was the outcome of this
adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Dec-18-2020
11:43:12
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: Del
etedNew Information
Dec-18-2020
11:43:12
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
REC
OVE
RING
/RES
OLVINew Information
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889965
Page 152 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
NG
Dec-18-2020
10:00:06
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: Rei
ssued:
Candi
datepending SDB update
Dec-17-2020
10:38:26
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: An
swere
dThe SAE is still ongoing. The FUP
form will be submited.
Dec-17-2020
09:19:52
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: Op
enedSAE
RECON:AER#2020489306,outcome
was reported as
Recovering/Resolving to Safety DB
however, recorded as NOT
RECOVERED/NOT RESOLVED
on AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Dec-10-2020
13:58:42
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
NOT
REC
OVE
RED/
NOT
RESOInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889966
Page 153 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
LVE
D
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-10-2020
13:58:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-11-2020
07:35:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2020489306Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889967
Page 154 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-16-2021
20:19:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/16/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-16-2021
20:19:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY
FOR ADDITIONAL V
ACCINATIONInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889968
Page 155 of 159
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Jan-20-2021
02:19:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Jan-19-2021
15:36:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Santiago
CorradettiQuery 1: Answered Changed data
per query
Jan-19-2021
15:36:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Santiago
CorradettiData Entry:
Not ApplicableInitial Entry
Jan-19-2021
03:28:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: Kindly
consider to
update this
form if require
else mark as
Not applicable
by selecting
form level
comment.
Thank you.
Jan-16-2021
20:18:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry: Transcription
Error
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889969
Page 156 of 159
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - 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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Jan-16-2021
20:18:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/16/2021Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889970
Page 157 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-23-2020
11:19:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-30-2020
14:44:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOM
IZEDInitial Entry
Aug-30-2020
14:43:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-23-2020
11:19:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
Aug-30-2020
14:44:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/30/2020Initial Entry
Aug-30-2020
14:43:17ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/30/2020Initial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889971
Page 158 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City
of Buenos Aires
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889972
Page 159 of 159
***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: 12315498 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-26-2020
19:56:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2eed\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889973