125742 S1 M5 CRF c4591001 4444 44441385

Document text

Page 1 of 166
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment
5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003368
Page 2 of 166
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/22/2020
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003369
Page 3 of 166
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Demography
1.Subject ID [44441385]
2.Birth Date: /1951
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003370
Page 4 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003371
Page 5 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003372
Page 6 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003373
Page 7 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Resolved prostate cancer]
Start Date: Mar/1/2012
Ongoing: NO
End Date:
Dec/1/2012
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: Sep/22/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Horton migraine]
Start Date: Feb/1/1980
Ongoing: YES
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003374
Page 8 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003375
Page 9 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
2.Weight: [81.0]
3.Unit: kg
4.Height: [170.0]
5.Unit: cm
6.Body Mass Index: [28.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003376
Page 10 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/22/2020
2.Randomization Number: [263528]
3.Randomization Group: [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003377
Page 11 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRVM6H]
5.bSample ID [BRVM65]
5.cSample ID [BHXGY8]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003378
Page 12 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWBT6]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003379
Page 13 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/22/2020 13:47
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
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003380
Page 14 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003381
Page 15 of 166
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003382
Page 16 of 166
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Oct/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003383
Page 17 of 166
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1V6L]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003384
Page 18 of 166
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/13/2020 11:48
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
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003385
Page 19 of 166
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003386
Page 20 of 166
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
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 [BPTCBS]
5.bSample ID [BJ5NTL]
5.cSample ID [BJ5NTD]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003387
Page 21 of 166
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003388
Page 22 of 166
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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: [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003389
Page 23 of 166
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003390
Page 24 of 166
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003391
Page 25 of 166
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003392
Page 26 of 166
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003393
Page 27 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003394
Page 28 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003395
Page 29 of 166
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003396
Page 30 of 166
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003397
Page 31 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003398
Page 32 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unplanned Assessments
1.Assessments
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003399
Page 33 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Ischemic myocardiopath
y worsening Feb/5/2021 1
2:00 NO
End Date Time:
Mar/9/2021 19:00
 Repeating
Pages
 2.ADVERSE E
VENT 2  Severe Aortic Stenosis  Jan/27/2021
12:00 NO
End Date Time:
Mar/9/2021 19:00
 Repeating
Pages
 3.ADVERSE E
VENT 3  Abdominal Aortic Aneur
ysm Feb/8/2021 1
0:50 NO
End Date Time:
Feb/26/2021 16:30
 Repeating
Pages
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003400
Page 34 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Ischemic myocardiopathy worsening]
4.Start Date Time: Feb/5/2021 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/9/2021 19:00
6.Toxicity Grade: 3
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
YES
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003401
Page 35 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021161548]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003402
Page 36 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Severe Aortic Stenosis]
4.Start Date Time: Jan/27/2021 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/9/2021 19:00
6.Toxicity Grade: 3
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
YES
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003403
Page 37 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021161580]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003404
Page 38 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Abdominal Aortic Aneurysm]
4.Start Date Time: Feb/8/2021 10:50
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/26/2021 16:30
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003405
Page 39 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
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[ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003406
Page 40 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003407
Page 41 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003408
Page 42 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003409
Page 43 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003410
Page 44 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003411
Page 45 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003412
Page 46 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003413
Page 47 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003414
Page 48 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003415
Page 49 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003416
Page 50 of 166
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/11/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003417
Page 51 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003418
Page 52 of 166
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003419
Page 53 of 166
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003420
Page 54 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003421
Page 55 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003422
Page 56 of 166
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003423
Page 57 of 166
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003424
Page 58 of 166
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003425
Page 59 of 166
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/29/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003426
Page 60 of 166
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003427
Page 61 of 166
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003428
Page 62 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003429
Page 63 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/3/2021
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003430
Page 64 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003431
Page 65 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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: [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003432
Page 66 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
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 [BPWC4C]
5.bSample ID [BS43C5]
5.cSample ID [BS43ML]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003433
Page 67 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
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 [BPWCMV]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003434
Page 68 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/3/2021 15:14
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
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003435
Page 69 of 166
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003436
Page 70 of 166
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/8/2021
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 [BR233Y]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003437
Page 71 of 166
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/8/2021 10:30
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
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003438
Page 72 of 166
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003439
Page 73 of 166
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003440
Page 74 of 166
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003441
Page 75 of 166
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003442
Page 76 of 166
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003443
Page 77 of 166
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003444
Page 78 of 166
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003445
Page 79 of 166
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/11/2020
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003446
Page 80 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003447
Page 81 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003448
Page 82 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-23-2020 08:13:11 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003449
Page 83 of 166
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormFeb-03-2021 16:08:41 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003450
Page 84 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-16-2021 22:22:26 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-16-2021 12:46:55 (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 Feb-14-2021 18:42:35 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Gonzalo Perez
Marc Approved Feb-06-2021 10:15:28 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) 
(6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003451
Page 85 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, GonzaloPerez, 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 14:21:46 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-12-2020 09:43:17 (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.
 N/A Nov-11-2020 12:21:06 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-10-2020 11:54:26 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003452
Page 86 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003453
Page 87 of 166
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-23-2020 08:09:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-23-2020 08:09:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003454
Page 88 of 166
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-23-2020 08:11:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Sep/22/2020Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003455
Page 89 of 166
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-22-2020 14:34:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
44441385Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-22-2020 14:34:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1951Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-23-2020 08:11:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-23-2020 08:11:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-23-2020 08:11:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003456
Page 90 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-23-2020 08:12:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003457
Page 91 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-23-2020 08:13:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-23-2020 08:13:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-23-2020 08:13:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003458
Page 92 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Sep-23-2020 08:16:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:Resolved prosta
te cancer
Start Date: Mar/1/2012
Ongoing: NO
End Date:
Dec/1/2012Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-23-2020 08:16:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 08:16:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Resolved prostate cancerInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-23-2020 08:16:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/1/2012Initial Entry
1.a Ongoing:
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003459
Page 93 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Sep-23-2020 08:16:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/1/2012Initial Entry
1.b
Date Location User Value Reason
Sep-23-2020 08:17:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Hypercholeste
rolemia
Start Date: Sep/22/2019
Ongoing: YESInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003460
Page 94 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.b Line/MH Number:
Date Location User Value Reason
Sep-23-2020 08:17:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 08:17:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HypercholesterolemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-23-2020 08:17:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-23-2020 08:17:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-23-2020 08:18:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:Horton migr
aine
Start Date: Feb/1/1980
Ongoing: YESInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003461
Page 95 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.c Line/MH Number:
Date Location User Value Reason
Sep-23-2020 08:18:23
(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
Sep-23-2020 08:18:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Horton migraineInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-23-2020 08:18:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/1/1980Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-23-2020 08:18:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003462
Page 96 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-23-2020 08:18:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
The subject is NOT known to b
e HIV POSITIVEInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003463
Page 97 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020 08:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-23-2020 08:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
81.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-23-2020 08:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-23-2020 08:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
170.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-23-2020 08:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
090177e196ae2e6b\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)
FDA-CBER-2021-5683-1003464
Page 98 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Sep-23-2020 08:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.0Initial Entry
7.a
Date Location User Value Reason
Sep-23-2020 08:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 36.8
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-23-2020 08:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-23-2020 08:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-23-2020 08:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
090177e196ae2e6b\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)
FDA-CBER-2021-5683-1003465
Page 99 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Sep-23-2020 08:19:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003466
Page 100 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-23-2020 08:19:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-23-2020 08:19:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
263528Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003467
Page 101 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 08:19:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 08:19:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020 14:17:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 08:19:38
(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.
Sep-23-2020 08:19:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003468
Page 102 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-23-2020 14:17:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRVM6HInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 14:17:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRVM6HInitial Entry
5.b
Date Location User Value Reason
Sep-23-2020 14:43:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BRVM65Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-23-2020 14:43:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BRVM65Initial Entry
5.c
Date Location User Value Reason
Sep-23-2020 17:28:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BHXGY8Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-23-2020 17:28:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BHXGY8Initial Entry
090177e196ae2e6b\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) (4)
(b) (4)
FDA-CBER-2021-5683-1003469
Page 103 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 08:19:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 08:19:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020 08:36:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 08:19:51
(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-23-2020 08:19:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003470
Page 104 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-23-2020 08:36:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPWBT6Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 08:36:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPWBT6Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003471
Page 105 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-23-2020 08:20:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020 08:20:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020 08:20:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-23-2020 08:20:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020 13:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020 08:20:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003472
Page 106 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Sep-23-2020 08:20:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-23-2020 08:20:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-23-2020 08:20:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-23-2020 08:20:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003473
Page 107 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-23-2020 08:20:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003474
Page 108 of 166
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-13-2020 16:41:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003475
Page 109 of 166
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Oct-13-2020 16:42:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
2.a
Date Location User Value Reason
Oct-13-2020 16:42:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 36.7
Temperature Uni
t:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-13-2020 16:42:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-13-2020 16:42:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.7Initial Entry
2.a Unit:
090177e196ae2e6b\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)
FDA-CBER-2021-5683-1003476
Page 110 of 166
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Oct-13-2020 16:42:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-13-2020 16:42:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003477
Page 111 of 166
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020 13:34:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 13:34:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 13:34:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 13:34:29
(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.
Oct-13-2020 13:34:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003478
Page 112 of 166
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-13-2020 13:34:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP1V6LInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-13-2020 13:34:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP1V6LInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003479
Page 113 of 166
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-13-2020 16:45:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-13-2020 16:45:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-13-2020 16:45:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-13-2020 16:45:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/13/2020 11:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-13-2020 16:45:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003480
Page 114 of 166
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
6. Body Side:
Date Location User Value Reason
Oct-13-2020 16:45:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-13-2020 16:45:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-13-2020 16:45:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-13-2020 16:45:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003481
Page 115 of 166
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-11-2020 12:21:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/11/2020Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003482
Page 116 of 166
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020 12:21:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020 12:21:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-11-2020 16:25:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-11-2020 12:21:22
(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-11-2020 12:21:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003483
Page 117 of 166
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nov-11-2020 16:25:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPTCBSInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-11-2020 16:25:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPTCBSInitial Entry
5.b
Date Location User Value Reason
Nov-11-2020 16:43:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BJ5NTLInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-11-2020 16:43:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BJ5NTLInitial Entry
5.c
Date Location User Value Reason
Nov-11-2020 16:43:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BJ5NTDInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-11-2020 16:43:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BJ5NTDInitial Entry
090177e196ae2e6b\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) (4)
(b) (4)
FDA-CBER-2021-5683-1003484
Page 118 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1003485
Page 119 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Feb-14-2021 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1003486
Page 120 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003487
Page 121 of 166
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-02-2021
16:36:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Mar-02-2021
07:55:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed term matched in both
database
Feb-26-2021
12:47:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered In the SAE follow-up
form on 18FEB2021
the term was updated.
In it it says "The term
SAE was updated to
Worsening ischemic
cardiomyopathy
(vignette 10 was
updated)".
Feb-26-2021
05:35:35ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON: The
term was updated to
090177e196ae2e6b\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)
FDA-CBER-2021-5683-1003488
Page 122 of 166
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos Aires'ischemic cardiopathy
worsening' in Safety
database however
recorded as 'Ischemic
MYOCARDIOPATHY
worsening'in AE CRF.
Please confirm correct
term. If safety update
is required, please
submit a follow-up
form.
Feb-23-2021
12:08:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered This information was
previously reported
Feb-23-2021
12:07:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered FU sent with SAE
update term on
18FEB2021.
Feb-22-2021
15:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened Clinical Please report
surgery: AVR surgery
& myocardial
revascularization
surgery; Lt Int
mammary Art
(LIMA)-Diag branch
(Ant descending Art)
bypass & venous
bypass to Rt coronary
Art. Lt vent systolic
function intraop with
mild deterioration
Feb-22-2021
15:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINICAL Event
term is 'ischemic
myocardiopathy
worsening'; however,
SAE term in
'myocardial ischemia'.
Please review SAE
event term, harmonize
090177e196ae2e6b\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)
FDA-CBER-2021-5683-1003489
Page 123 of 166
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
reporting, and update
where appropriate
Feb-19-2021 11:36:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Ischemic myocardiopathy
worseningNew Information
Feb-14-2021
18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Ischemic cardiopathyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-02-2021 16:25:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-23-2021 12:10:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Yes, on 05Feb2021
present symptoms.
Feb-22-2021 15:19:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opened Clinical Thank you
for updated term;
does the start date
of 05Feb21 remain
in view of 16Jan21
SPECT with 5% of
LV ischemic.
Feb-19-2021 11:38:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered SAE form FU was
sent. SAE term is
updated.
Feb-17-2021 18:20:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Clinical Event of
ischemic
cardiomyopathy
start date is
05Feb21; however,
SAE reports
SPECT myocardial
scan on 16Jan21
revealed 5% of LV
090177e196ae2e6b\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)
FDA-CBER-2021-5683-1003490
Page 124 of 166
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
was ischemic.
Please review start
date, and update if
appropriate
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/5/2021 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 16:46:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Mar/9/2021 19:00New Information
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-02-2021 16:34:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
090177e196ae2e6b\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) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1003491
Page 125 of 166
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-23-2021 12:11:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered Both covid tests
were previously
reported in the
SAE form.
Feb-22-2021 15:28:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened Clinical Please
report negative
COVID test reports
on 05 and 07 Feb
2021 to this SAE
(#2021161548) as
well (from
#202161580)
Feb-16-2021 22:22:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Ischemic
cardiopathy:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event resul
t in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1003492
Page 126 of 166
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
YES
Did this serious event resul
t in persistent or significant
disability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important
serious event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1003493
Page 127 of 166
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021 16:45:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Feb-19-2021 11:36:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGNew Information
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-14-2021 18:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e6b\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)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1003494
Page 128 of 166
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-16-2021 22:22:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2021161548Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003495
Page 129 of 166
***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, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Feb-14-2021 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-14-2021 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-02-2021 16:24:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-24-2021 12:06:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered AE log CRF was
updated. Thank
you.
Feb-22-2021 14:52:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened Clinical On
review of the SAE
report for Aortic
Stenosis, an event
of Aortic
aneurysm was
reported [doppler
Echo 08Feb21],
yet it does not
appear in the CRF.
Please review for
safety and update
AE log CRF
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003496
Page 130 of 166
***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, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
accordingly (in
AE reporting
period)
Feb-22-2021 14:51:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed rewording
Feb-22-2021 14:47:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Clinical On
review of the SAE
report for Aortic
Stenosis, an event
of Aortic
aneurysm was
reported, yet it
does not appear in
the CRF. Please
review for safety
and update AE log
CRF accordingly
(in AE reporting
period)
Feb-14-2021 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Severe Aortic StenosisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-17-2021 18:05:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed error
Feb-17-2021 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Clinical SAE of
AS has start date
of 05Feb2021;
however, SAE lab
section states
ECHO on 27Jan21
reported severe
AS. Please review
start date of event,
090177e196ae2e6b\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)
FDA-CBER-2021-5683-1003497
Page 131 of 166
***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, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
and update if
applicable in both
AE/SAE report
Feb-14-2021 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/27/2021 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 17:04:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-11-2021 17:04:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Mar/9/2021 19:00Transcription Error
Mar-11-2021 16:46:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For Severe Aortic
Stenosis End Date
19/Mar/2021, is a
future date relative
to when it was
entered on 11/Mar
/2021. Please
correct.
Mar-11-2021 16:46:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Mar/19/2021 19:00New Information
Feb-14-2021 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2e6b\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)
FDA-CBER-2021-5683-1003498
Page 132 of 166
***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, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-14-2021 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; 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
Feb-16-2021 22:22:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-14-2021 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Severe
Aortic Stenosis:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Feb-14-2021 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result in
death?
NO
Did this serious event require
or prolong hospitalization?
YESInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1003499
Page 133 of 166
***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, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Did this serious event result in
persistent or significant disabi
lity/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-14-2021 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-14-2021 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1003500
Page 134 of 166
***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, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-14-2021 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-14-2021 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-14-2021 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-13-2021
12:04:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Answered FU was sent on 3/11 where the
status was updated to recovered.
Thanks.
Mar-12-2021
11:48:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Opened SAE RECON:AER#2021161580
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.
Mar-11-2021
16:46:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDNew Information
090177e196ae2e6b\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)
FDA-CBER-2021-5683-1003501
Page 135 of 166
***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, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-24-2021
16:42:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies query
Feb-24-2021
12:07:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-24-2021
12:07:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERING/RE
SOLVINGNew Information
Feb-24-2021
00:01:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#021161580,outcome
was reported as
Recovering/Resolving to Safety
DB however, recorded as NOT
RECOVERED/NOT RESOLVED
on AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Feb-14-2021
18:45:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-14-2021 18:45:24
(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
Feb-16-2021 22:22:41
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
2021161580Initial Entry
090177e196ae2e6b\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) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1003502
Page 136 of 166
***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, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003503
Page 137 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-26-2021 10:23:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-24-2021 10:12:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The aneurysm was
diagnosed in an
Echodoppler
performed on
08feb2021. At the
moment, no
intervention has
been performed for
this pathology, only
monitoring.
Feb-24-2021 08:24:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Clinquery: Was the
Abdominal Aortic
Aneurysm found on
ultrasound/
CT/MRI? No
surgery/treatment
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003504
Page 138 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
needed, just
monitoring? Thank
you.
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Abdominal Aortic Aneurys
mInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/8/2021 10:50Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-27-2021 10:21:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/26/2021 16:30New Information
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae2e6b\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)
FDA-CBER-2021-5683-1003505
Page 139 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2e6b\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)
FDA-CBER-2021-5683-1003506
Page 140 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-26-2021 20:39:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESNew Information
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-27-2021 10:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-27-2021 10:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Feb-27-2021 10:21:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Abdominal
Aortic Aneurysm:
Response to "What
was the outcome of
this adverse
event?" is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
090177e196ae2e6b\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)
FDA-CBER-2021-5683-1003507
Page 141 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-23-2021 16:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003508
Page 142 of 166
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-11-2020 12:21:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-11-2020 12:21:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-11-2020 12:21:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003509
Page 143 of 166
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-29-2021 14:21:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/29/2021Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003510
Page 144 of 166
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-29-2021 14:22:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-29-2021 14:21:54
(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 14:21:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible per local/national r
ecommendations and confi
rmed to have received only
placebo at Vaccination 1/2Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003511
Page 145 of 166
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-29-2021 14:22:03
(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 14:22:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATIO
NInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003512
Page 146 of 166
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021 16:08:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/3/2021Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003513
Page 147 of 166
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-03-2021 16:08:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Feb/3/2021Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003514
Page 148 of 166
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-03-2021 16:09:38
(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 16:09:38
(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 16:09:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003515
Page 149 of 166
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-03-2021 16:09:48
(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 16:09:48
(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 15:40:59
(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 16:09:48
(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 16:09:48 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1003516
Page 150 of 166
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresYES
Date of Collection:
Feb/3/2021
5.a
Date Location User Value Reason
Feb-04-2021 15:40:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPWC4CInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-04-2021 15:40:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPWC4CInitial Entry
5.b
Date Location User Value Reason
Feb-04-2021 17:09:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Sample ID: BS43C5Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-04-2021 17:09:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
BS43C5Initial Entry
5.c
Date Location User Value Reason
090177e196ae2e6b\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) (4)
FDA-CBER-2021-5683-1003517
Page 151 of 166
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-04-2021 18:14:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Sample ID: BS43MLInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-04-2021 18:14:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
BS43MLInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003518
Page 152 of 166
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-03-2021 16:09:56
(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 16:09:56
(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 09:33:09
(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 16:09:56
(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 16:09:56 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1003519
Page 153 of 166
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresYES
Date of Collection:
Feb/3/2021
5.a
Date Location User Value Reason
Feb-04-2021 09:33:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPWCMVInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-04-2021 09:33:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPWCMVInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003520
Page 154 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-03-2021 16:10:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-03-2021 16:10:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-03-2021 16:10:13
(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 16:10:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/3/2021 15:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-03-2021 16:10:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003521
Page 155 of 166
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Feb-03-2021 16:10:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-03-2021 16:10:13
(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 16:10:13
(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 16:10:13
(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 16:10:13
(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 16:10:13
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003522
Page 156 of 166
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003523
Page 157 of 166
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User ValueReason
Mar-11-2021
03:29:07
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: Clo
sedClosed per
SITE response,
added to PD
tracker for
Clinical
Review.
Mar-10-2021
11:54:33
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: An
swere
dThe visit took
place outside
the window for
medical
reasons of the
participant
(related to their
adverse event)
Mar-10-2021
07:18:10
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of
visit
V102_VAX4 is
out of window
for 10 days
from
V101_VAX3
Dose Date.
Please verify
and update.
Else, confirm
in query
response
appropriately.
Mar-08-2021
13:18:33
(UTC-03:00)
City of
BuenosACV0PFEINFP6000  Data
Entry
:
Mar/8
/2021Initial Entry
090177e196ae2e6b\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) (4)
FDA-CBER-2021-5683-1003524
Page 158 of 166
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Aires
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003525
Page 159 of 166
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021 13:18:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021 13:18:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-09-2021 11:53:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-09-2021 07:38:17
(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.
Mar-08-2021 13:18:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1003526
Page 160 of 166
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Mar-08-2021 13:18:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/8/2021Initial Entry
5.a
Date Location User Value Reason
Mar-09-2021 11:53:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR233YInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-09-2021 11:53:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR233YInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003527
Page 161 of 166
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-08-2021 13:19:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-08-2021 13:19:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-08-2021 13:19:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-08-2021 13:19:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/8/2021 10:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-08-2021 13:19:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003528
Page 162 of 166
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Mar-08-2021 13:19:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Mar-08-2021 13:19:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-08-2021 13:19:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-08-2021 13:19:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-08-2021 13:19:39
(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
Mar-08-2021 13:19:39
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003529
Page 163 of 166
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003530
Page 164 of 166
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-10-2021 09:39:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed V102 added
Mar-05-2021 05:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Candidate DM Requery 1:
As per response,
please reschedule
V102 and record
the visit details in
inform. Further,
please answer to
this query. Thank
you.
Mar-04-2021 16:28:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The visit will be
scheduled shortly.
Thanks
Mar-04-2021 03:53:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: V102
overdue based on
expected visit
window. Please
enter data or, if
visit will never
occur, mark Date
of Visit as Not
Done with form
level comment
Nov-11-2020 12:21:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-23-2020 08:19:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZE
DInitial Entry
Sep-23-2020 08:13:51 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae2e6b\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)
FDA-CBER-2021-5683-1003531
Page 165 of 166
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos Aires(autocalc) SCREENED
2. Subject Status Date
Date Location User Value Reason
Nov-11-2020 12:21:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/11/2020Initial Entry
Sep-23-2020 08:19:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/22/2020Initial Entry
Sep-23-2020 08:13:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/22/2020Initial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003532
Page 166 of 166
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44441385 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020 11:54:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2e6b\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003533