125742 S1 M5 CRF c4591001 4444 44442012

Document text

Page 1 of 119
***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: 44442012 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
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006270
Page 2 of 119
***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: 44442012 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/25/2020
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006271
Page 3 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Demography
1.Subject ID [44442012]
2.Birth Date: /1950
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006272
Page 4 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006273
Page 5 of 119
***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: 44442012 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
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006274
Page 6 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006275
Page 7 of 119
***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: 44442012 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:[depression]
Start Date: May/1/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[arterial hypertension]
Start Date: Jun/1/2016
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: Jun/1/2016
Ongoing: YES
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006276
Page 8 of 119
***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: 44442012 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
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006277
Page 9 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
2.Weight: [119.0]
3.Unit: kg
4.Height: [181.0]
5.Unit: cm
6.Body Mass Index: [36.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006278
Page 10 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/25/2020
2.Randomization Number: [265879]
3.Randomization Group: [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006279
Page 11 of 119
***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: 44442012 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/25/2020
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 [BRVS20]
5.bSample ID [BKPG5J]
5.cSample ID [BRVS27]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006280
Page 12 of 119
***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: 44442012 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/25/2020
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 [BPWSBD]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006281
Page 13 of 119
***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: 44442012 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/25/2020 17:30
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
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006282
Page 14 of 119
***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: 44442012 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
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006283
Page 15 of 119
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L 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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/9/2020
2.Erroneous Visit
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006284
Page 16 of 119
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Dec/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006285
Page 17 of 119
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 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:
Dec/9/2020
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 [BPWSXY]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006286
Page 18 of 119
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L 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: 44442012 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?YES
Date of First Delay:
Nov/1/2020
Reason(s) for Temporary Delay of Vaccination
RECENT SYSTEMIC CORTICOSTEROID TREATMENT
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Dec/9/2020 17:59
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
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006287
Page 19 of 119
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L 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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006288
Page 20 of 119
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[subject unable to attend, visit made by telephone contact]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006289
Page 21 of 119
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006290
Page 22 of 119
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 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 [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006291
Page 23 of 119
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006292
Page 24 of 119
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 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 [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006293
Page 25 of 119
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006294
Page 26 of 119
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 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 [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006295
Page 27 of 119
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 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:
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006296
Page 28 of 119
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 44442012 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: [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006297
Page 29 of 119
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 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 [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006298
Page 30 of 119
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 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 [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006299
Page 31 of 119
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 44442012 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?
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006300
Page 32 of 119
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 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:
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006301
Page 33 of 119
***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: 44442012 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:
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006302
Page 34 of 119
***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: 44442012 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 [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006303
Page 35 of 119
***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: 44442012 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:
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006304
Page 36 of 119
***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: 44442012 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 [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006305
Page 37 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006306
Page 38 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unplanned Assessments
1.Assessments
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006307
Page 39 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
 1.ADVERSE EVE
NT 1  Left peripheral facial p
alsy Oct/31/2020 08:
00 NO
End Date Time:
Nov/20/2020 08:00
 Repeating
Pages
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006308
Page 40 of 119
***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: 44442012 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)[Left peripheral facial palsy]
4.Start Date Time: Oct/31/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/20/2020 08:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006309
Page 41 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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[ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006310
Page 42 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006311
Page 43 of 119
***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: 44442012 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[ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006312
Page 44 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006313
Page 45 of 119
***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: 44442012 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: //
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006314
Page 46 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006315
Page 47 of 119
***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: 44442012 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?
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006316
Page 48 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006317
Page 49 of 119
***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: 44442012 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?
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006318
Page 50 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006319
Page 51 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006320
Page 52 of 119
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Mar/2/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006321
Page 53 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006322
Page 54 of 119
***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: 44442012 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:
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006323
Page 55 of 119
***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: 44442012 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?
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006324
Page 56 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006325
Page 57 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006326
Page 58 of 119
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - 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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006327
Page 59 of 119
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006328
Page 60 of 119
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 44442012 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 [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006329
Page 61 of 119
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 44442012 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 [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006330
Page 62 of 119
***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: 44442012 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: [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006331
Page 63 of 119
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006332
Page 64 of 119
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006333
Page 65 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/3/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006334
Page 66 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006335
Page 67 of 119
***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: 44442012 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: [ ]
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006336
Page 68 of 119
***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: 44442012 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 Mar/2/2021
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006337
Page 69 of 119
***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: 44442012 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
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006338
Page 70 of 119
***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: 44442012 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
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006339
Page 71 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-27-2020 09:29:51 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006340
Page 72 of 119
***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: 44442012 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 Mar-03-2021 12:07:37 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Gonzalo Perez
Marc Approved Jan-22-2021 17:20:55 (UTC-03:00) City of Buenos
AiresBOOK Signed
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.
Alan Colombo  N/A Dec-10-2020 15:30:01 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-25-2020 18:48:57 (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-20-2020 16:42:50 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006341
Page 73 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
N/A
 Approved Nov-13-2020 19:15:27 (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-12-2020 13:53:49 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-10-2020 12:28:23 (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.
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006342
Page 74 of 119
***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: 44442012 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-27-2020 09:27:28
(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-27-2020 09:27:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006343
Page 75 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-27-2020 09:27:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/25/2020Initial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006344
Page 76 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-25-2020 17:19:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
44442012Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-25-2020 17:19:00
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1950Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-27-2020 09:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-27-2020 09:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-27-2020 09:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006345
Page 77 of 119
***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: 44442012 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-12-2020 15:47:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-12-2020 10:45:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered subject has not a
rescheduled visit yet
Nov-12-2020 04:07:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened GPD Clinical: Please
clarify when the
subject will be
coming for Vax2,
thank you.
Nov-11-2020 09:55:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Candidate GPD Clinical: Please
clarify when the
subject will be
coming for Vax2,
thank you.
Sep-27-2020 09:28:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-1006346
Page 78 of 119
***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: 44442012 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-27-2020 09:30:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-27-2020 09:30:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-27-2020 09:30:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006347
Page 79 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Sep-27-2020 09:31:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term: depression
Start Date: May/1/2015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-27-2020 09:31:51
(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-27-2020 09:31:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
depressionInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-27-2020 09:31:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
May/1/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-27-2020 09:31:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-27-2020 09:33:20
(UTC-03:00) City of BuenosACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2Initial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006348
Page 80 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Aires Medical History Te
rm:arterial hypertens
ion
Start Date: Jun/1/2016
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Sep-27-2020 09:33:20
(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-27-2020 09:33:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
arterial hypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-27-2020 09:33:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jun/1/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-27-2020 09:33:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-27-2020 09:41:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Hypercholesterol
emia
Start Date: Jun/1/2016
Ongoing: YESInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006349
Page 81 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.c Line/MH Number:
Date Location User Value Reason
Sep-27-2020 09:41:07
(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-27-2020 09:41:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HypercholesterolemiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-27-2020 09:41:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jun/1/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-27-2020 09:41:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006350
Page 82 of 119
***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: 44442012 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-27-2020 09:41:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
The subject is NOT known to be HI
V POSITIVEInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006351
Page 83 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Sep-27-2020 09:42:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-27-2020 09:42:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
119.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-27-2020 09:43:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-27-2020 09:43:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
181.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-27-2020 09:43:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-27-2020 09:43:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
36.3Initial Entry
Sep-27-2020 09:42:11
(UTC-03:00) City of BuenosACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-1006352
Page 84 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Aires
7.a
Date Location User Value Reason
Sep-27-2020 09:43:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
Sep-27-2020 09:42:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature:
Temperature Unit:
Temperature Location::Initial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-27-2020 09:42:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-27-2020 09:43:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-27-2020 09:43:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-27-2020 09:43:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (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)
FDA-CBER-2021-5683-1006353
Page 85 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-27-2020 09:44:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-27-2020 09:44:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
265879Initial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006354
Page 86 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-27-2020 09:44:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-27-2020 09:44:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-27-2020 10:09:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-27-2020 09:44:51
(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-27-2020 09:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-27-2020 10:09:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRVS20Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006355
Page 87 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-27-2020 10:09:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRVS20Initial Entry
5.b
Date Location User Value Reason
Sep-27-2020 10:54:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BKPG5JInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-27-2020 10:54:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BKPG5JInitial Entry
5.c
Date Location User Value Reason
Sep-27-2020 11:49:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Sample ID: BRVS27Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-27-2020 11:49:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
BRVS27Initial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006356
Page 88 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-27-2020 09:45:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-27-2020 09:45:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-27-2020 09:59:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-27-2020 09:45:09
(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-27-2020 09:45:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-27-2020 09:59:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BPWSBDInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006357
Page 89 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-27-2020 09:59:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BPWSBDInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006358
Page 90 of 119
***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: 44442012 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-27-2020 09:46:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-27-2020 09:46:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-27-2020 09:46:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-27-2020 09:46:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/25/2020 17:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-27-2020 09:46:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-27-2020 09:46:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006359
Page 91 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Sep-27-2020 09:46:08
(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-27-2020 09:46:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-27-2020 09:46:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006360
Page 92 of 119
***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: 44442012 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-27-2020 09:46:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006361
Page 93 of 119
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User ValueReason
Feb-23-2021
12:25:11
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
4: Clo
sedResponse satisfies query
Feb-23-2021
09:30:38
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Query
4: Ans
weredthe visit has been cancelled
multiple times by the subject,
the surveillance team is
working to confirm with
subject to schedule the v3
visit, information will be
uploaded as soon as possible
Feb-22-2021
15:34:32
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Rivkah Rosen Query
4: Op
enedVisit
“V3_MONTH1_POSTVAX2”
was expected to occur on
“13-JAN-2021”. Please enter
data or confirm reason why
visit has not yet occurred. If
subject is no longer in the
trial, please complete the
Disposition Follow Up form.
Dec-16-2020
04:06:50
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
3: Clo
sedClosed as TDV updated
Dec-15-2020
12:26:05
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Santiago Corradetti Query
3: Ans
weredChanged data per query
Dec-15-2020
03:57:06
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Clo
sedanother query raised
Dec-15-2020
03:56:49
(UTC-03:00)ACV0PFEINFP6000  Query
3: Op
enedPDQ RQ1: As per your
response, please confirm
whether corresponding temp.
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006362
Page 94 of 119
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
City of
Buenos Airesdelay details can be updated
on Vaccination form (either
V1 or V2) as appropriate. Else
clarify.
Dec-15-2020
03:54:34
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Rei
ssued:
Opene
dPDQ RQ1: As per your
response, Visit was out of
window due to temporary
delay of vaccination. Thus,
please confirm whether
corresponding temp. delay
details can be updated on
Vaccination form (either V1
or V2) as appropriate. Else
clarify.
Dec-14-2020
10:51:35
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Ans
weredGood morning Subject had a
AE, facial paralysis that
resolved with cortico steroids
. Was a temporal delay Thnak
you
Dec-14-2020
02:34:31
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
2: Op
enedPDQ: Date of visit at
V2_VAX2_L is out of
window for 52 days from
V1_DAY1_VAX1_L Dose
Date. Please verify and
update. Else, confirm in query
response appropriately. 
Dec-11-2020
12:18:13
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Dec/9
/2020Initial Entry
Nov-30-2020
16:56:13
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Marjorie Buonanno Query
1: Clo
sedResponse satisfies query
Nov-30-2020
14:40:32
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Ans
weredAE form is already complete.
Per protocol due to dose and
duration of corticoids does not
meet criteria for prohibited
concomitant medication.
Thank you
Nov-30-2020
13:31:05ACV0PFEINFP6000  Marjorie Buonanno Query
1: ReiGPD Clin: Thank you for
your response, however
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006363
Page 95 of 119
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00)
City of
Buenos Airesssued:
Opene
dplease provide prohibited
concomitant medication and
document on the appropriate
Prohibited con drug page.
Also provide reason drug was
given and record as AE of
appropriate
Nov-25-2020
18:51:40
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Ans
weredSubject suffered temporary
delay for vaccine 2 due to
concomitant prohibited
medication until 9NOV2020.
Dose 2 will be scheduled once
28 days had passed from last
day of treatment
Nov-25-2020
17:59:37
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Marjorie Buonanno Query
1: Op
enedGPD Clin: Please confirm if
there was a temporary delay
for Vaccine 2 and provide
reason.
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006364
Page 96 of 119
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Dec-11-2020 12:19:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/9/2020Initial Entry
2.a
Date Location User Value Reason
Dec-11-2020 12:19:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-11-2020 12:19:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Dec-11-2020 12:19:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-11-2020 12:19:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Dec-11-2020 12:19:44 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-1006365
Page 97 of 119
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresORAL CAVITY
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1006366
Page 98 of 119
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-10-2020 15:30:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-10-2020 15:30:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-10-2020 15:30:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-10-2020 15:30:01
(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.
Dec-10-2020 15:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
YES
Date of Collection:
Dec/9/2020Initial Entry
5.a
Date Location User Value Reason
Dec-10-2020 15:30:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BPWSXYInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006367
Page 99 of 119
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Dec-10-2020 15:30:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPWSXYInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006368
Page 100 of 119
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L 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: 44442012 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
Jan-08-2021 10:37:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-15-2020 12:25:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Subject was originally
out of window due to
job issues; but on
1-NOV he started an
oral corticosteroid
treatment for a Facial
Paralysis that lasted
until 9-NOV (which
is the final reason of
the temporary delay).
Dec-15-2020 12:25:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Santiago
CorradettiData Entry:
YES
Date of First Delay:
Nov/1/2020
Reason(s) for Temporary Delay of
Vaccination
RECENT SYSTEMIC CORTIC
OSTEROID TREATMENTSubject was originally
out of window due to
job issues; but on
1-NOV he started an
oral corticosteroid
treatment for a Facial
Paralysis that lasted
until 9-NOV (which
is the final reason of
the temporary delay).
Dec-15-2020 07:34:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Juleen Gayed Query 1: Opened Clin: Vaccination 2 is
outside of window,
however temporary
delay response is
"No", please confirm
why the second
vaccination was
administered so late
after the first
vaccination?
Dec-11-2020 12:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006369
Page 101 of 119
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L 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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Dec-11-2020 12:20:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-11-2020 12:20:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-11-2020 12:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/9/2020 17:59Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-11-2020 12:20:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-11-2020 12:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Dec-11-2020 12:20:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-11-2020 12:20:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006370
Page 102 of 119
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L 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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Dec-11-2020 12:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006371
Page 103 of 119
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021 20:06:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-04-2021 11:13:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered done
Mar-04-2021 05:34:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: The treatment
period is defined as
1st vaccination visit
through the 1-month
post vaccination visit
after the 2nd
vaccination. Please
complete treatment
disposition CRF and
update date of EOT
to match date of visit
at visit 3.
Mar-03-2021 12:07:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/2/2021Initial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006372
Page 104 of 119
***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, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-03-2021 12:09:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-03-2021 12:09:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-03-2021 12:09:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Mar-03-2021 12:09:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
subject unable to attend, visit made
by telephone contactInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006373
Page 105 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Nov-03-2020 13:20:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006374
Page 106 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Nov-03-2020 13:20:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-03-2020 13:20:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-04-2020 16:10:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 5: Closed Response satisfies
query
Dec-04-2020 15:33:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 5: Answered Lyme titres were not
available. Thank you.
Dec-04-2020 12:46:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 6: Closed Response satisfies
query
Dec-04-2020 12:45:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 5: Reissued:Opened clin: Thank you. Pls
advise if Lyme titres
(antibodies) sent.
Dec-04-2020 12:24:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 6: Answered Since the
methylprednisone
treatment lasted 8
days, it does not
included in a
prohibited medication.
Thank you.
Dec-04-2020 12:17:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 5: Answered The subject received
acyclovir 800 mg per
day every 4 hours
since Nov,1 until
Nov,2. The Bell´s
palsy has a mild
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (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)
FDA-CBER-2021-5683-1006375
Page 107 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
sequelae and the
subject has no history
of blistering rash.
Thank you.
Dec-04-2020 11:28:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 6: Opened clin: please add the
methylprednisone
given to treat the facial
palsy to the prohibited
ConMed CRF. Thanks
Dec-04-2020 11:19:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 5: Opened clin: pls advise if
subject received
acyclovir or other
treatment in addition
to steroids and if has
any sequelae from the
Bell's. Did the subject
have Lyme titres sent
and do they have any
history of a 'blistering
rash' Thank you
Dec-04-2020 11:17:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 4: Closed reissued.
Dec-04-2020 11:02:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 4: Opened clin: pls advise which,
if any, medications
used for treatment and
advise if subject has
any sequelae from the
Bell's. Thank you.
Nov-24-2020 12:47:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Nov-24-2020 12:16:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Santiago
CorradettiQuery 3: Answered Subject had no history
of prior facial palsy.
Thank you.
Nov-24-2020 11:55:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Opened clinical: pls confirm
subject with no prior
hx Bell's/facial palsy.
Thanks
Nov-12-2020 13:53:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Left peripheral facial palsyNew Information
Nov-10-2020 12:22:34 ACV0PFEINFP6000  Query 2: Closed Response satisfies
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1006376
Page 108 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos Airesquery
Nov-10-2020 12:16:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered The volunteer has no
history of herpes virus
infection. Visit 2 has
not yet been made due
to personal problems
of the volunteer. When
done, the form will be
completed. Thank you
Nov-10-2020 10:56:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened clinical: pls advise if
pt has hx of herpes
simplex infections and
update MedHx CRF as
appropriate. Vax2 CRF
has not been
completed, pt not
listed as withdrawn,
pls advise if V2 CRF
inadvertently not
completed or reason
Vax 2 not given
Nov-05-2020 06:34:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Steven De
BeukelaerQuery 1: Closed Response satisfies
query
Nov-04-2020 16:19:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Subject didn´t have
any other associated
symptoms. thanks
Nov-04-2020 08:30:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Steven De
BeukelaerQuery 1: Opened GPDCLIN: while
cause of Bell's palsy is
often unknown, it can
be viral. Did subject
display any viral
infection flu-like
symptoms ?
Nov-03-2020 13:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
right peripheral facial palsyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-03-2020 13:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/31/2020 08:00Initial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (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) (4)
(b) (4)
FDA-CBER-2021-5683-1006377
Page 109 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-24-2020 13:45:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-24-2020 10:53:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Santiago
CorradettiQuery 2: Answered As a treatment for the
facial palsy, the
subject received oral
Meprednisone for a
week until 9-NOV.
Visit 2 will be
scheduled for 28-35
days from that date, as
the protocol demands
Nov-24-2020 05:44:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Balaji Prabu R Query 2: Opened GPD Clinical: please
clarify if the subject
received the second
vaccination, thank
you.
Nov-23-2020 10:41:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Candidate GPD Clinical: please
clarify if the subject
received the second
vaccination, thank
you.
Nov-20-2020 16:42:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/20/2020 08:00New Information
Nov-13-2020 12:11:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Juleen Gayed Query 1: Closed Response satisfies
query
Nov-12-2020 14:47:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESTranscription Error
Nov-12-2020 14:29:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Nov-12-2020 14:29:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina Davalli Data Entry:
NO
End Date Time:New Information
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006378
Page 110 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nov/9/2020 UNK:UNK
Nov-12-2020 12:30:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Juleen Gayed Query 1: Opened Clin: Please confirm
if this AE is still
ongoing?
Nov-03-2020 13:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-03-2020 13:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-03-2020 13:20:43
(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
Nov-03-2020 13:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-03-2020 13:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHERInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (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)
FDA-CBER-2021-5683-1006379
Page 111 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
If Other, specify:
Unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-03-2020 13:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-03-2020 13:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-03-2020 13:20:43
(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
Nov-20-2020 16:43:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-20-2020 16:43:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-20-2020 16:42:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE Left peripheral
facial palsy: Response
to "What was the
outcome of this
adverse event?" is 'Not
Recovered/Not
Resolved' but AE End
Date/Time is present.
Nov-12-2020 14:47:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006380
Page 112 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nov-12-2020 14:29:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Left peripheral
facial palsy: Response
to "What was the
outcome of this
adverse event?" is 'Not
Recovered/Not
Resolved' but AE End
Date/Time is present.
Nov-03-2020 13:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-03-2020 13:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006381
Page 113 of 119
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 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
Mar-04-2021 11:13:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/2/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-04-2021 11:13:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Mar-04-2021 11:13:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006382
Page 114 of 119
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-03-2021 17:52:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/3/2021Initial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006383
Page 115 of 119
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442012 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
Mar-03-2021 17:53:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-03-2021 17:53:02
(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.
Mar-03-2021 17:53:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing to return for Vac
cination 3
Participant is:
eligible and NOT confirmed to ha
ve received only placebo at Vaccin
ation 1/2Initial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006384
Page 116 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-03-2021 17:53:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/3/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-03-2021 17:53:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADDIT
IONAL VACCINATIONInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006385
Page 117 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-04-2021 11:13:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Mar-03-2021 12:12:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed V3 is added
Mar-02-2021 14:51:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Rivkah Rosen Query 1: Reissued:Candidate Check back week of
3/15 to see if Visit 3
has been completed.
Mar-02-2021 10:21:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Visit 3 is out of
window for personal
reasons of the
participant.
Information will be
updated when
available.
Mar-02-2021 02:46:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: Visit 3 is
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. If subject is
no longer in the trial,
complete the
Disposition FUP
form.
Sep-27-2020 09:44:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-27-2020 09:30:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006386
Page 118 of 119
***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: 44442012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Mar-04-2021 11:13:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Mar/2/2021Initial Entry
Sep-27-2020 09:44:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
Sep-27-2020 09:30:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006387
Page 119 of 119
***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: 44442012 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 12:27:00
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2ece\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-1006388