Document text
Page 1 of 153
***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: 12315653 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
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891343
Page 2 of 153
***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: 12315653 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/31/2020
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891344
Page 3 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Demography
1.Subject ID [12315653]
2.Birth Date: /1959
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0891345
Page 4 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891346
Page 5 of 153
***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: 12315653 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
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891347
Page 6 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891348
Page 7 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[arterial hypertension]
Start Date: Jan/1/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[GLAUCOMA ]
Start Date: Jul/1/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[OBESITY]
Start Date: Jul/1/2005
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[RIGHT DEAF]
Start Date: Jul/1/1960
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[ISOLATED HEMATOCHESIS]
Start Date: Aug/15/2020
Ongoing: YES
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891349
Page 8 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Glaucoma in both eyes]
Start Date: Jul/1/2017
Ongoing: YES
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891350
Page 9 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [128.0]
3.Unit: kg
4.Height: [179.0]
5.Unit: cm
6.Body Mass Index: [39.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891351
Page 10 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [247431]
3.Randomization Group: [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891352
Page 11 of 153
***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: 12315653 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/31/2020
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 [BP266S]
5.bSample ID [BP266T]
5.cSample ID [BP266V]
5.dSample ID [BNTWYR]
5.eSample ID [BNTWYS]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891353
Page 12 of 153
***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: 12315653 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/31/2020
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 [BP25SH]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891354
Page 13 of 153
***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: 12315653 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/31/2020 17:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891355
Page 14 of 153
***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: 12315653 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
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891356
Page 15 of 153
***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: 12315653 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
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891357
Page 16 of 153
***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: 12315653 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: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891358
Page 17 of 153
***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: 12315653 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 [BPWF1R]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891359
Page 18 of 153
***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: 12315653 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 15:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891360
Page 19 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/14/2020
2.Erroneous Visit
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891361
Page 20 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/14/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRVRBD]
5.bSample ID [BRVR9Z]
5.cSample ID [BPXJ8B]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891362
Page 21 of 153
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12315653 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:
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891363
Page 22 of 153
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12315653 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: [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891364
Page 23 of 153
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12315653 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 [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891365
Page 24 of 153
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12315653 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 [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891366
Page 25 of 153
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12315653 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?
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891367
Page 26 of 153
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12315653 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:
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891368
Page 27 of 153
***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: 12315653 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:
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891369
Page 28 of 153
***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: 12315653 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 [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891370
Page 29 of 153
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit 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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891371
Page 30 of 153
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: 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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unplanned Assessments
1.Assessments
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891372
Page 31 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891373
Page 32 of 153
***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: 12315653 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: [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891374
Page 33 of 153
***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: 12315653 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:
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891375
Page 34 of 153
***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: 12315653 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 [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891376
Page 35 of 153
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled 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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891377
Page 36 of 153
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 12315653 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:
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891378
Page 37 of 153
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 12315653 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?
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891379
Page 38 of 153
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891380
Page 39 of 153
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891381
Page 40 of 153
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891382
Page 41 of 153
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 12315653 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
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891383
Page 42 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891384
Page 43 of 153
***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: 12315653 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
Feb/3/2021
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891385
Page 44 of 153
***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: 12315653 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
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891386
Page 45 of 153
***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: 12315653 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 :Feb/3/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891387
Page 46 of 153
***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: 12315653 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:
Feb/3/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWC4F]
5.bSample ID [BS43C7]
5.cSample ID [BS43MN]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891388
Page 47 of 153
***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: 12315653 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/3/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWCMZ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891389
Page 48 of 153
***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: 12315653 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/3/2021 14:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891390
Page 49 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891391
Page 50 of 153
***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: 12315653 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/24/2021
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 [BR28JK]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891392
Page 51 of 153
***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: 12315653 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/24/2021 17:28
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891393
Page 52 of 153
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/25/2021
2.Erroneous Visit
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891394
Page 53 of 153
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 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/25/2021
3.Comments: [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891395
Page 54 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891396
Page 55 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891397
Page 56 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891398
Page 57 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891399
Page 58 of 153
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 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/25/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891400
Page 59 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#CategoryAE Identifie
rAdverse Event Start DateIs the Adverse Event Still Ongoi
ngForm Instance
1.ADVERSE EVEN
T 1 Ischemic stroke
Oct/12/2020 17:0
0 NO
End Date Time:
Oct/16/2020 17:30
Repeating Pages
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891401
Page 60 of 153
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 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)[Ischemic stroke]
4.Start Date Time: Oct/12/2020 17:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/16/2020 17:30
6.Toxicity Grade: 2
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]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891402
Page 61 of 153
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
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[2020404742]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891403
Page 62 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891404
Page 63 of 153
***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: 12315653 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[ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891405
Page 64 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891406
Page 65 of 153
***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: 12315653 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: //
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891407
Page 66 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891408
Page 67 of 153
***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: 12315653 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?
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891409
Page 68 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891410
Page 69 of 153
***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: 12315653 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?
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891411
Page 70 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891412
Page 71 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891413
Page 72 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/29/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891414
Page 73 of 153
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891415
Page 74 of 153
***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: 12315653 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: [ ]
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891416
Page 75 of 153
***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: 12315653 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 Nov/14/2020
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891417
Page 76 of 153
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 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
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891418
Page 77 of 153
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891419
Page 78 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-31-2020 18:23:51 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891420
Page 79 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormFeb-03-2021 16:04:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0891421
Page 80 of 153
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-25-2021 15:37:33 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-06-2021 09:26:56 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-25-2021 10:51:48 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-05-2021 07:57:45 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-03-2021 16:03:55 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0891422
Page 81 of 153
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
N/A
Approved Feb-01-2021 17:57:55 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-29-2021 13:36:53 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando Polack Approved Nov-16-2020 12:06:29 (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 Nov-16-2020 09:22:41 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Santiago
Corradetti Approved Nov-15-2020 15:31:13 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0891423
Page 82 of 153
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, SantiagoCorradetti, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-14-2020 11:52:11 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-13-2020 18:49:37 (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 Nov-13-2020 12:25:15 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-11-2020 18:51:53 (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.
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0891424
Page 83 of 153
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
N/A Nov-11-2020 13:56:24 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-10-2020 10:38:35 (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 Nov-08-2020 10:40:06 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-06-2020 15:45:17 (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.
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0891425
Page 84 of 153
***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: 12315653 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-31-2020 18:22:52
(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-31-2020 18:22:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0891426
Page 85 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-31-2020 18:23:00
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/31/2020Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0891427
Page 86 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020 16:43:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12315653Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020 16:43:36
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1959Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020 18:23:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020 18:23:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR OF SP
ANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-31-2020 18:23:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0891428
Page 87 of 153
***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: 12315653 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-31-2020 18:23:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0891429
Page 88 of 153
***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: 12315653 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-31-2020 18:24:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020 18:24:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020 18:24:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0891430
Page 89 of 153
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.a
Date Location User Value Reason
Aug-31-2020 18:24:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:arterial hypertens
ion
Start Date: Jan/1/2005
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-31-2020 18:24:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 18:24:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
arterial hypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-31-2020 18:24:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Jan/1/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-31-2020 18:24:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0891431
Page 90 of 153
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Nov-09-2020 17:14:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Number: 2
Medical History Te
rm:GLAUCOM
A
Start Date: Jul/1/2017
Ongoing: YESTranscription Error
(DELETED)
Nov-09-2020 09:42:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana Estrada Data Entry:
Line/MH Number: 2
Medical History Te
rm:GLAUCOM
A
Start Date: Jul/1/2017
Ongoing: YESInitial Entry
Nov-09-2020 09:40:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana Estrada Data Entry:
Line/MH Number: 2
Medical History Te
rm:GLAUCOM
A
Start Date: Jul/1/2017
Ongoing:New Information
Nov-08-2020 10:40:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:GLAUCOM
A
Start Date:
Ongoing:Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0891432
Page 91 of 153
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.b Line/MH Number:
Date Location User Value Reason
Nov-09-2020 17:14:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Transcription Error
(DELETED)
Nov-08-2020 10:40:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-09-2020 17:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-09-2020 17:14:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
GLAUCOMATranscription Error
(DELETED)
Nov-09-2020 17:13:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered medhx duplicated,
duplication will be
deleted. thank you
Nov-09-2020 16:24:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINQUERY: Term
GLAUCOMA
appears to be a
duplicated on the
medhx CRF. Please
verify and update the
CRF as appropriate,
else clarify. If
verified, please retain
the entry that
specifies which
eye(s).
Nov-08-2020 10:40:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
GLAUCOMAInitial Entry
1.b Start Date:
Date Location User Value Reason
Nov-10-2020 04:00:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0891433
Page 92 of 153
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Nov-09-2020 17:14:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jul/1/2017Transcription Error
(DELETED)
Nov-09-2020 09:40:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Nov-09-2020 09:40:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana Estrada Data Entry:
Jul/1/2017New Information
Nov-09-2020 06:00:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: Please update
start date and ongoing
field or else clarify.
Thank you.
1.b Ongoing:
Date Location User Value Reason
Nov-09-2020 17:14:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESTranscription Error
(DELETED)
Nov-09-2020 09:42:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana Estrada Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Nov-09-2020 09:42:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana
EstradaData Entry:
Line/MH Number: 3
Medical History Term: OBESITY
Start Date: Jul/1/2005
Ongoing: YESInitial Entry
Nov-09-2020 09:40:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana
EstradaData Entry:
Line/MH Number: 3
Medical History Term: OBESITY
Start Date: Jul/1/2005
Ongoing:New Information
Nov-08-2020 10:40:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term: OBESITY
Start Date:
Ongoing:Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0891434
Page 93 of 153
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.c Line/MH Number:
Date Location User Value Reason
Nov-08-2020 10:40:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-08-2020 10:40:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBESITYInitial Entry
1.c Start Date:
Date Location User Value Reason
Nov-10-2020 02:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Closed as data
entered.
Nov-09-2020 09:40:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Nov-09-2020 09:40:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana Estrada Data Entry:
Jul/1/2005New Information
Nov-09-2020 06:00:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: Please update
start date and ongoing
field or else clarify.
Thank you.
1.c Ongoing:
Date Location User Value Reason
Nov-09-2020 09:42:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana
EstradaData Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Nov-09-2020 09:42:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana
EstradaData Entry:
Line/MH Number: 4Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891435
Page 94 of 153
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Medical History Ter
m:RIGHT DEA
F
Start Date: Jul/1/1960
Ongoing: YES
Nov-09-2020 09:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana
EstradaData Entry:
Line/MH Number: 4
Medical History Ter
m:RIGHT DEA
F
Start Date: Jul/1/1960
Ongoing:New Information
Nov-08-2020 10:40:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:RIGHT DEA
F
Start Date:
Ongoing:Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891436
Page 95 of 153
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.d Line/MH Number:
Date Location User Value Reason
Nov-08-2020 10:40:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-08-2020 10:40:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RIGHT DEAFInitial Entry
1.d Start Date:
Date Location User Value Reason
Nov-10-2020 02:26:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Closed as data
entered.
Nov-09-2020 09:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Nov-09-2020 09:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana Estrada Data Entry:
Jul/1/1960New Information
Nov-09-2020 06:00:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Amol Shinde Query 1: Opened DM: Please update
start date and ongoing
field or else clarify.
Thank you.
1.d Ongoing:
Date Location User Value Reason
Nov-09-2020 09:42:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana
EstradaData Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Nov-09-2020 09:42:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana
EstradaData Entry:
Line/MH Num
ber:5Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891437
Page 96 of 153
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Medical Histor
y Term:ISOLATED HEMA
TOCHESIS
Start Date: Aug/15/2020
Ongoing: YES
Nov-09-2020 09:42:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana
EstradaData Entry:
Line/MH Num
ber:5
Medical Histor
y Term:ISOLATED HEMA
TOCHESIS
Start Date: Aug/15/2020
Ongoing:New Information
Nov-08-2020 10:41:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:ISOLATED HEMA
TOCHESIS
Start Date:
Ongoing:Initial Entry
1.e Line/MH Number:
Date Location User Value Reason
Nov-08-2020 10:41:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-08-2020 10:41:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ISOLATED HEMATOCHESISInitial Entry
1.e Start Date:
Date Location User Value Reason
Nov-10-2020 02:26:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Closed as data
entered.
Nov-09-2020 09:42:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891438
Page 97 of 153
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.e Start Date:
Date Location User Value Reason
Nov-09-2020 09:42:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana
EstradaData Entry:
Aug/15/2020New Information
Nov-09-2020 06:00:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: Please update
start date and ongoing
field or else clarify.
Thank you.
1.e Ongoing:
Date Location User Value Reason
Nov-09-2020 09:42:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana
EstradaData Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Nov-09-2020 12:26:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:Glaucoma in both
eyes
Start Date: Jul/1/2017
Ongoing: YESInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891439
Page 98 of 153
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.f Line/MH Number:
Date Location User Value Reason
Nov-09-2020 12:26:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-09-2020 12:26:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Glaucoma in both eyesInitial Entry
1.f Start Date:
Date Location User Value Reason
Nov-09-2020 12:26:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Jul/1/2017Initial Entry
1.f Ongoing:
Date Location User Value Reason
Nov-09-2020 12:26:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891440
Page 99 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 18:25:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020 18:25:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
128.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020 18:25:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-31-2020 18:25:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
179.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-31-2020 18:25:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0891441
Page 100 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-31-2020 18:25:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
39.9Initial Entry
7.a
Date Location User Value Reason
Aug-31-2020 18:25:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.4
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 18:25:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-31-2020 18:25:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-31-2020 18:25:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-31-2020 18:25:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0891442
Page 101 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-31-2020 18:25:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-31-2020 18:25:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
247431Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0891443
Page 102 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 18:25:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 18:25:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 10:16:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-01-2020 04:49:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-31-2020 18:25:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-31-2020 18:25:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 10:16:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP266SInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891444
Page 103 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 10:16:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP266SInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020 10:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP266TInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020 10:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP266TInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020 10:17:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP266VInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020 10:17:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP266VInitial Entry
5.d
Date Location User Value Reason
Sep-01-2020 11:51:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNTWYRInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891445
Page 104 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.d Sample ID
Date Location User Value Reason
Sep-01-2020 11:51:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BNTWYRInitial Entry
5.e
Date Location User Value Reason
Sep-01-2020 11:51:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNTWYSInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-01-2020 11:51:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BNTWYSInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891446
Page 105 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 18:25:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 18:25:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 13:04:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-01-2020 04:49:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-31-2020 18:25:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-31-2020 18:25:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 13:04:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP25SHInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891447
Page 106 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 13:04:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP25SHInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891448
Page 107 of 153
***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: 12315653 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-31-2020 18:26:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 18:26:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 18:26:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020 18:26:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020 17:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 18:26:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020 18:26:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0891449
Page 108 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
7. Route:
Date Location User Value Reason
Aug-31-2020 18:26:09
(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-31-2020 18:26:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-31-2020 18:26:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0891450
Page 109 of 153
***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: 12315653 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-31-2020 18:26:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0891451
Page 110 of 153
***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: 12315653 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 17:07:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0891452
Page 111 of 153
***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: 12315653 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 17:07:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020Initial Entry
2.a
Date Location User Value Reason
Sep-19-2020 17:07:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.1
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-19-2020 17:07:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-19-2020 17:07:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-19-2020 17:07:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-19-2020 17:07:17
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0891453
Page 112 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891454
Page 113 of 153
***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: 12315653 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 17:07:29
(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 17:07:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-21-2020 09:27:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-20-2020 03:04:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-19-2020 17:07:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-19-2020 17:07:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/19/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0891455
Page 114 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-21-2020 09:27:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPWF1RInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-21-2020 09:27:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPWF1RInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891456
Page 115 of 153
***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: 12315653 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 17:08:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-19-2020 17:08:04
(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 17:08:04
(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 17:08:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020 15:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-19-2020 17:08:04
(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 17:08:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0891457
Page 116 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Sep-19-2020 17:08:04
(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 17:08:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-19-2020 17:08:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0891458
Page 117 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-15-2020
12:36:32
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
3: Clo
sedResponse satisfies query
Nov-15-2020
10:43:44
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Tatiana Estrada Query
3: Ans
wereddate of visit is correct. subject
is out of window as he was
hospitalized between V2 and
V3 due to a stroke
Nov-15-2020
03:45:12
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
3: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 21 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately.
Nov-14-2020
11:52:24
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query
2: Del
etedClose Auto Query
Nov-14-2020
11:52:11
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query
2: Can
didateErroneous Visit is marked, but
date of visit is entered. Please
check whether other
assessments are performed at
this visit.
Nov-14-2020
11:52:11
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data
Entry
:
Nov/1
4/202
0Initial Entry
Nov-12-2020
16:11:41
(UTC-03:00)
City ofACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0891459
Page 118 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
Nov-12-2020
15:14:38
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
1: Ans
weredYes, V3 is planned for
November 14th. thanks
Nov-12-2020
12:32:59
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
1: Op
enedCLINQUERY: Please clarify if
V3 is planned to occur, or if it
will be skipped. Thank you.
2. Erroneous Visit
Date Location User Value Reason
Nov-14-2020 11:52:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Nov-13-2020 12:25:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0891460
Page 119 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-14-2020 11:52:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-14-2020 11:52:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-14-2020 13:35:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-14-2020 11:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-14-2020 11:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/14/2020Initial Entry
5.a
Date Location User Value Reason
Nov-14-2020 13:35:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRVRBDInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891461
Page 120 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Nov-14-2020 13:35:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRVRBDInitial Entry
5.b
Date Location User Value Reason
Nov-16-2020 09:22:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRVR9ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-16-2020 09:22:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRVR9ZInitial Entry
5.c
Date Location User Value Reason
Nov-16-2020 10:42:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPXJ8BInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-16-2020 10:42:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPXJ8BInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891462
Page 121 of 153
***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: 12315653 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
Nov-14-2020 11:52:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Nov/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-14-2020 11:52:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-14-2020 11:52:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891463
Page 122 of 153
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-29-2021 13:36:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891464
Page 123 of 153
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-29-2021 13:37:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-29-2021 13:37:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Jan-29-2021 13:37:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing to return for Va
ccination 3
Participant is:
eligible per local/national recomm
endations and confirmed to have r
eceived only placebo at Vaccinatio
n 1/2Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891465
Page 124 of 153
***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: 12315653 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-03-2021 16:03:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Feb/3/2021Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0891466
Page 125 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-03-2021 16:04:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/3/2021Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0891467
Page 126 of 153
***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: 12315653 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
Feb-03-2021 16:05:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Feb/3/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-03-2021 16:05:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-03-2021 16:05:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0891468
Page 127 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-03-2021 16:05:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-03-2021 16:05:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-04-2021 15:42:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-04-2021 06:32:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-03-2021 16:05:21
(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-03-2021 16:05:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/3/2021Initial Entry
5.a
Date Location User Value Reason
Feb-04-2021 15:42:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPWC4FInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0891469
Page 128 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a Sample ID
Date Location User Value Reason
Feb-04-2021 15:42:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPWC4FInitial Entry
5.b
Date Location User Value Reason
Feb-04-2021 17:10:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BS43C7Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-04-2021 17:10:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BS43C7Initial Entry
5.c
Date Location User Value Reason
Feb-04-2021 18:15:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BS43MNInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-04-2021 18:15:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BS43MNInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891470
Page 129 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-03-2021 16:05:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-03-2021 16:05:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-04-2021 09:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-04-2021 06:32:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-03-2021 16:05:35
(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-03-2021 16:05:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/3/2021Initial Entry
5.a
Date Location User Value Reason
Feb-04-2021 09:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPWCMZInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891471
Page 130 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a Sample ID
Date Location User Value Reason
Feb-04-2021 09:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPWCMZInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891472
Page 131 of 153
***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: 12315653 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-03-2021 16:06:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-03-2021 16:06:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-03-2021 16:06:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-03-2021 16:06:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Feb/3/2021 14:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-03-2021 16:06:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-03-2021 16:06:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0891473
Page 132 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
7. Route:
Date Location User Value Reason
Feb-03-2021 16:06:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-03-2021 16:06:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-03-2021 16:06:05
(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-03-2021 16:06:05
(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-03-2021 16:06:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0891474
Page 133 of 153
***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: 12315653 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-25-2021 10:51:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/24/2021Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891475
Page 134 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-25-2021 10:52:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-25-2021 10:52:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-25-2021 11:53:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-25-2021 10:52:17
(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-25-2021 10:52:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/24/2021Initial Entry
5.a
Date Location User Value Reason
Feb-25-2021 11:53:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR28JKInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891476
Page 135 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Feb-25-2021 11:53:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR28JKInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891477
Page 136 of 153
***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: 12315653 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-25-2021 10:52:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-25-2021 10:52:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-25-2021 10:52:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-25-2021 10:52:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/24/2021 17:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-25-2021 10:52:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-25-2021 10:52:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891478
Page 137 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
7. Route:
Date Location User Value Reason
Feb-25-2021 10:52:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-25-2021 10:52:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-25-2021 10:52:53
(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-25-2021 10:52:53
(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-25-2021 10:52:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891479
Page 138 of 153
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 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-25-2021 15:37:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/25/2021Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891480
Page 139 of 153
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-25-2021 15:38:37
(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-25-2021 15:38:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Mar/25/2021Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891481
Page 140 of 153
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 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-25-2021 15:39:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/25/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-25-2021 15:39:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-25-2021 15:39:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891482
Page 141 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Oct-17-2020 15:06:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891483
Page 142 of 153
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category:
Date Location User Value Reason
Oct-17-2020 15:06:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-17-2020 15:06:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-09-2020 15:11:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-09-2020 14:14:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The adverse event still
continues as imaging
studies and neurology
control are pending (in
Nov and Dec). It was
the symptoms that
gave way, not the
event itself. Thank
you.
Nov-09-2020 06:51:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Clinical - SAE
(#2020404742)
received the event end
date in Narrative;
however, it was not
entered under EVENT
in the end date box.
Please update with the
end date under the
stroke Event, and
submit a safety f/u
Nov-06-2020 12:18:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Candidate Clinical - SAE
(#2020404742)
received the event end
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891484
Page 143 of 153
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
date in Narrative;
however, it was not
entered under EVENT
in the end date box.
Please update with the
end date under the
stroke Event, and
submit a safety f/u
Oct-17-2020 15:06:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Ischemic strokeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 07:19:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Onset date updated in
SDB to 12Oct2020.
Issue resolved
Oct-26-2020 07:33:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Candidate SAE RECON: Pending
SDB update and PSSR
review
Oct-25-2020 16:14:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered I confirm the follow-up
SAE form was sent on
23OCT2020. Thank
you.
Oct-23-2020 07:38:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 1: In the
latest SAE listing, the
onset date is still
13Oct2020. Per
narrative of the case
'On 13Oct2020 17:00,
the subject experienced
ischemic stroke'. Please
confirm if follow up
AEM form was sent
Oct-22-2020 01:20:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Candidate SAE RECON: To
check next SAE listing
Oct-21-2020 10:22:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The correct Onset Date
is 12OCT2020. A
follow-up SAE form
was sent.
Oct-20-2020 06:21:09
(UTC-03:00) City ofACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020404742
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891485
Page 144 of 153
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
Oct-17-2020 15:06:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/12/2020 17:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-11-2020 13:56:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/16/2020 17:30New Information
Nov-06-2020 15:44:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESTranscription Error
Nov-03-2020 15:17:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/16/2020 UNK:UNKNew Information
Nov-02-2020 12:49:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESTranscription Error
Nov-02-2020 12:04:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/16/2020 UNK:UNKNew Information
Oct-17-2020 15:06:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-17-2020 15:06:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0891486
Page 145 of 153
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 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
Oct-28-2020 01:22:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Oct-27-2020 15:38:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered During hospitalization,
the patient underwent a
SARS-COV-2 RT-PCR
test. On OCT 17, 2020
the results were
obtained: negative.
This information was
not included in the
epicrisis of
hospitalization. Serious
adverse event
follow-up form is sent.
Oct-23-2020 15:52:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened Clinical COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020404742] to
provide whether
COVID testing was
performed (yes/no) and
if yes, the results.
Oct-20-2020 06:17:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-19-2020 08:43:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE RECON:Ischemic
stroke(Onset
date:12Oct2020) is not
reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891487
Page 146 of 153
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-17-2020 15:06:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Ischemic
stroke: Response to "Is
the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-17-2020 15:06:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated wit
h congenital anomaly or birth defe
ct?
NO
Did this serious event result in deat
h?
NO
Did this serious event require or pr
olong hospitalization?
YES
Did this serious event result in pers
istent or significant disability/incap
acity?
NO
Is this serious event life threatenin
g?
NO
Other medically important serious
event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-17-2020 15:06:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891488
Page 147 of 153
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-17-2020 15:06:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-17-2020 15:06:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-17-2020 15:06:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-17-2020 15:06:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-11-2020 13:56:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 7: Closed Close Auto Query
Nov-11-2020 13:56:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-11-2020 13:56:24
(UTC-03:00) City ofACV0PFEINFP6000 auto query
(autoquery)Query 7: Opened For AE Ischemic stroke:
Response to "What was the
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0891489
Page 148 of 153
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires outcome of this adverse
event?" is
'Recovering/Resolving' but
AE End Date/Time is
present.
Nov-07-2020 12:59:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 5: Closed Response satisfies query
Nov-06-2020 15:44:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 6: Closed Close Auto Query
Nov-06-2020 15:44:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 6: Opened For AE Ischemic stroke:
Response to "What was the
outcome of this adverse
event?" is
'Recovering/Resolving' but
AE End Date/Time is
present.
Nov-06-2020 15:44:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 5: Answered On 2-11-2020, a serious
adverse event follow-up
form was sent with the
clarification that the
neurological symptoms
resolved on OCT 16, 2020.
Nov-06-2020 15:44:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGOn 2-11-2020, a serious
adverse event follow-up
form was sent with the
clarification that the
neurological symptoms
resolved on OCT 16, 2020.
Nov-06-2020 12:53:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 5: Opened SAE
RECON:AER#2020404742
,outcome was updated to
RECOVERED/RESOLVED
on AE CRF while reported
as Recovering/resolving in
Safety database. Please
submit a follow up form to
update outcome in Safety
database.
Nov-04-2020 19:15:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Closed Response satisfies query
Nov-04-2020 17:48:30 ACV0PFEINFP6000 Query 4: Answered follow up form was sent.
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0891490
Page 149 of 153
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City of
Buenos Airesthank you
Nov-04-2020 04:03:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed corrected query text
Nov-04-2020 04:03:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Opened SAE
RECON:AER#2020404742
,outcome was updated to
RECOVERED/RESOLVED
on AE CRF while reported
as Recovering/resolving in
Safety database. Please
confirm correct outcome. If
safety update is required,
please submit a follow-up
form.
Nov-04-2020 03:59:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened SAE
RECON:AER#2020385783
,outcome was updated to
RECOVERED/RESOLVED
on AE CRF while reported
as Recovering/resolving in
Safety database. Please
confirm correct outcome. If
safety update is required,
please submit a follow-up
form.
Nov-03-2020 16:13:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies query
Nov-03-2020 15:18:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered Changed data per query
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0891491
Page 150 of 153
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-03-2020 13:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened CLINQUERY: For AE
Ischemic stroke:
Response to "What was
the outcome of this
adverse event?" is
'Recovered/Resolved'
but AE is reported as
ONGOOING. Please
reconcile.
Nov-02-2020 12:05:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-02-2020 12:05:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-02-2020 12:04:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Ischemic stroke:
Response to "What was
the outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-17-2020 15:06:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-17-2020 15:06:58
(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
Oct-20-2020 06:17:19
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
2020404742Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891492
Page 151 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-29-2021 13:37:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-29-2021 13:37:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR ADDIT
IONAL VACCINATIONInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891493
Page 152 of 153
***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: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-14-2020 11:52:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-31-2020 18:25:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-31-2020 18:24:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-14-2020 11:52:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/14/2020Initial Entry
Aug-31-2020 18:25:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
Aug-31-2020 18:24:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891494
Page 153 of 153
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315653 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-06-2020 15:43:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2e67\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891495