125742 S1 M5 CRF c4591001 4444 44441422

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
184
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 184
***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: 44441422 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
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003534
Page 2 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/22/2020
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003535
Page 3 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Demography
1.Subject ID [44441422]
2.Birth Date: /1955
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003536
Page 4 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003537
Page 5 of 184
***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: 44441422 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
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003538
Page 6 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003539
Page 7 of 184
***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: 44441422 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:[Arterial hypertension]
Start Date: Jun/2/2003
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypercholesterolemia]
Start Date: Jun/2/2003
Ongoing: YES
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003540
Page 8 of 184
***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: 44441422 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
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003541
Page 9 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
2.Weight: [99.0]
3.Unit: kg
4.Height: [175.0]
5.Unit: cm
6.Body Mass Index: [32.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003542
Page 10 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/22/2020
2.Randomization Number: [263646]
3.Randomization Group: [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003543
Page 11 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPXHP9]
5.bSample ID [BRVL6H]
5.cSample ID [BRVL65]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003544
Page 12 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWT8T]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003545
Page 13 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/22/2020 15:17
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003546
Page 14 of 184
***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: 44441422 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
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003547
Page 15 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003548
Page 16 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Oct/12/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003549
Page 17 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
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 [BPXX14]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003550
Page 18 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/12/2020 12:12
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003551
Page 19 of 184
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003552
Page 20 of 184
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTCC6]
5.bSample ID [BJ4DGB]
5.cSample ID [BJ5NV1]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003553
Page 21 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003554
Page 22 of 184
***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: 44441422 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 [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003555
Page 23 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003556
Page 24 of 184
***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: 44441422 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 [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003557
Page 25 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003558
Page 26 of 184
***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: 44441422 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 [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003559
Page 27 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003560
Page 28 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/15/2020
2.Date of First Symptom
Started:Dec/15/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/16/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003561
Page 29 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Abdominal pain]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003562
Page 30 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
 1.Dec/15/
2020 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003563
Page 31 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/15/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASOPHARYNX
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003564
Page 32 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
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: 44441422 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_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[Sample collected by team physician.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003565
Page 33 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: 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: 44441422 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/15/2020
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 [BPWT0F]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003566
Page 34 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003567
Page 35 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
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?NO
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003568
Page 36 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003569
Page 37 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003570
Page 38 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?YES
Respiratory Illness Diagnosis:
[acute diverticulitis]
Date of Diagnosis:
Dec/15/2020
3.Toxicity Grade: 1
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003571
Page 39 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003572
Page 40 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003573
Page 41 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003574
Page 42 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003575
Page 43 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003576
Page 44 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003577
Page 45 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003578
Page 46 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003579
Page 47 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003580
Page 48 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003581
Page 49 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003582
Page 50 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: OXYGENATION PARAMETERS
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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003583
Page 51 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003584
Page 52 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 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.Start Date: //
6.Ongoing?
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003585
Page 53 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003586
Page 54 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003587
Page 55 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/12/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003588
Page 56 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/12/2021Form: 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: 44441422 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:
Jan/12/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRYT2V]
5.bSample ID [BRYT36]
5.cSample ID [BPTBZD]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003589
Page 57 of 184
***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: 44441422 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:
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003590
Page 58 of 184
***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: 44441422 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 [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003591
Page 59 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003592
Page 60 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unplanned Assessments
1.Assessments
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003593
Page 61 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event S
till OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Pain in lef
t heel Sep/28/2020
10:00 NO
End Date Time:
Sep/28/2020 18:00
 Repeating
Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003594
Page 62 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 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)[Pain in left heel]
4.Start Date Time: Sep/28/2020 10:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/28/2020 18:00
6.Toxicity Grade: 1
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003595
Page 63 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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:
[spur background]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003596
Page 64 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003597
Page 65 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003598
Page 66 of 184
***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: 44441422 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[ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003599
Page 67 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003600
Page 68 of 184
***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: 44441422 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: //
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003601
Page 69 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003602
Page 70 of 184
***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: 44441422 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?
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003603
Page 71 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003604
Page 72 of 184
***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: 44441422 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?
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003605
Page 73 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003606
Page 74 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003607
Page 75 of 184
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/11/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003608
Page 76 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003609
Page 77 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 44441422 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:
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003610
Page 78 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 44441422 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?
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003611
Page 79 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003612
Page 80 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003613
Page 81 of 184
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003614
Page 82 of 184
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003615
Page 83 of 184
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 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 [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003616
Page 84 of 184
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 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 [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003617
Page 85 of 184
***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: 44441422 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: [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003618
Page 86 of 184
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003619
Page 87 of 184
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 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
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003620
Page 88 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/2/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003621
Page 89 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003622
Page 90 of 184
***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: 44441422 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: [ ]
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003623
Page 91 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/11/2020
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003624
Page 92 of 184
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 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
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003625
Page 93 of 184
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 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
Name Signature
MeaningDate Type Action
Gonzalo
Perez Marc Approved Feb-06-2021 10:19:19 (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.
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003626
Page 94 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-23-2020 08:39:32 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003627
Page 95 of 184
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 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
Name Signature
MeaningDate Type Action
Gonzalo
Perez Marc Approved Feb-06-2021 10:19:19 (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.
 N/A Feb-02-2021 12:44:32 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-21-2021 11:21:03 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003628
Page 96 of 184
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Dec-17-2020 12:57:01 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-12-2020 09:18:02 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003629
Page 97 of 184
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Nov-11-2020 13:21:36 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-10-2020 11:14:35 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003630
Page 98 of 184
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, , verify that all case report form pages
accurately display the results of the examinations, tests, evaluations and treatments performed on
this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003631
Page 99 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-23-2020
08:39:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-23-2020
08:39:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003632
Page 100 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-23-2020
08:39:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/22/2020Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003633
Page 101 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-22-2020
15:33:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
44441422Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-23-2020
08:38:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1955New
Information
Sep-22-2020
15:33:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1955Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-23-2020
08:38:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003634
Page 102 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Sep-23-2020
08:38:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATI
NO(A) OR OF SPAN
ISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-23-2020
08:38:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003635
Page 103 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-23-2020
08:39:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003636
Page 104 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-23-2020
08:39:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-23-2020
08:39:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-23-2020
08:39:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003637
Page 105 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Sep-23-2020
08:40:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:Arterial h
ypertensi
on
Start Date: Jun/2/200
3
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-23-2020
08:40:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020
08:40:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Arterial hypertensionInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003638
Page 106 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.a Start Date:
Date Location User Value Reason
Sep-23-2020
08:40:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jun/2/2003Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-23-2020
08:40:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-23-2020
08:41:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:Hypercho
lesterolem
ia
Start Date
:Jun/2/200
3
Ongoing: YESInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003639
Page 107 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.b Line/MH Number:
Date Location User Value Reason
Sep-23-2020
08:41:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020
08:41:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
HypercholesterolemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-23-2020
08:41:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jun/2/2003Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-23-2020
08:41:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003640
Page 108 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-23-2020
08:41:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
The subject is NOT k
nown to be HIV POSI
TIVEInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003641
Page 109 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020
08:41:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-23-2020
08:41:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
99.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-23-2020
08:41:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-23-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003642
Page 110 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
08:41:59
(UTC-03:00) City
of Buenos Aires175.0
5. Unit:
Date Location User Value Reason
Sep-23-2020
08:41:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-23-2020
08:41:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.3Initial Entry
7.a
Date Location User Value Reason
Sep-23-2020
08:41:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.5
Temperatu
re Unit:CInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003643
Page 111 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-23-2020
08:41:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-23-2020
08:41:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-23-2020
08:41:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003644
Page 112 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-23-2020
08:41:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003645
Page 113 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-23-2020
08:42:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-23-2020
08:42:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
263646Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003646
Page 114 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020
08:42:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020
08:42:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020
12:00:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-23-2020
08:42:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003647
Page 115 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Sep-23-2020
08:42:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020
12:00:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPXHP
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-23-2020
12:00:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPXHP9Initial Entry
5.b
Date Location User Value Reason
Sep-23-2020
13:25:01
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Sample I BRVL6Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003648
Page 116 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires D: H
5.b Sample ID
Date Location User Value Reason
Sep-23-2020
13:25:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRVL6HInitial Entry
5.c
Date Location User Value Reason
Sep-23-2020
14:56:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BRVL6
5Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-23-2020
14:56:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BRVL65Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003649
Page 117 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020
08:42:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020
08:42:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020
11:51:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-23-2020
08:42:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003650
Page 118 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Sep-23-2020
08:42:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020
11:51:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPWT8
TInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-23-2020
11:51:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPWT8TInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003651
Page 119 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-23-2020
08:42:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020
08:42:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020
08:42:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-23-2020
08:42:41ACV0PFEINFP6000  Data Entry:
Sep/22/2020 15:17Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003652
Page 120 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020
08:42:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-23-2020
08:42:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-23-2020
08:42:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-23-2020
08:42:41ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003653
Page 121 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-23-2020
08:42:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003654
Page 122 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-23-2020
08:42:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003655
Page 123 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-12-2020
19:09:41
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003656
Page 124 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Oct-12-2020
19:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
2.a
Date Location User Value Reason
Oct-12-2020
19:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record I
dentifier:
:1
Temperat
ure:36.6
Temperat
ure Unit:C
Temperat
ure Locat
ion::ORAL
CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-12-2020
19:09:49ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003657
Page 125 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00)
City of Buenos
Aires
2.a Temperature:
Date Location User Value Reason
Oct-12-2020
19:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-12-2020
19:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-12-2020
19:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003658
Page 126 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020
19:09:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020
19:09:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020
10:32:59
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-13-2020
07:56:56
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003659
Page 127 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Aires are entered.
Please review
and correct as
appropriate.
Oct-12-2020
19:09:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-12-2020
19:09:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020
10:32:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPXX1
4Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003660
Page 128 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-13-2020
10:32:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPXX14Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003661
Page 129 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-12-2020
19:10:07
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-12-2020
19:10:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-12-2020
19:10:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-12-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003662
Page 130 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
19:10:07
(UTC-03:00)
City of Buenos
AiresOct/12/2020 12:12
5. Anatomical Location:
Date Location User Value Reason
Oct-12-2020
19:10:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-12-2020
19:10:07
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-12-2020
19:10:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003663
Page 131 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Oct-12-2020
19:10:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-12-2020
19:10:07
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003664
Page 132 of 184
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-11-2020
13:21:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/11/2020Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003665
Page 133 of 184
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-11-2020
16:29:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-11-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003666
Page 134 of 184
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Nov-11-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
Nov-11-2020
16:29:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPTCC
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-11-2020
16:29:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTCC6Initial Entry
5.b
Date Location User Value Reason
Nov-11-2020
16:45:45
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Sample ID BJ4DGInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003667
Page 135 of 184
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires : B
5.b Sample ID
Date Location User Value Reason
Nov-11-2020
16:45:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BJ4DGBInitial Entry
5.c
Date Location User Value Reason
Nov-11-2020
16:51:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BJ5NV
1Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-11-2020
16:51:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BJ5NV1Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003668
Page 136 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-17-2020
13:01:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Dec-17-2020
12:57:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
missing.
Please review
and update as
appropriate.
Dec-17-2020
12:57:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in
both Nasal
Swab Self and
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003669
Page 137 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nasal Swab
are missing.
Please review
and update as
appropriate.
Dec-17-2020
12:57:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/15/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-17-2020
12:57:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003670
Page 138 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/15/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-29-2020
12:20:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/15/2020Transcription
Error
Dec-17-2020
13:11:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/3/2020Transcription
Error
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/15/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003671
Page 139 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Dec-21-2020
13:30:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symp
tom Resolved:
Dec/16/2020New
Information
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEV
ER
Symptom Pr
esent:YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003672
Page 140 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR I
NCREASE
D COUGH
Sympt
om Pre
sent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003673
Page 141 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.c
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symp
toms:NEW OR IN
CREASED S
HORTNESS
OF BREATH
Symp
tom
Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED SHORTNESS O
F BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003674
Page 142 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHIL
LS
Symptom Pr
esent:NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE PInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003675
Page 143 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
AIN
Sympt
om Pr
esent:NO
4.e Symptoms:
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELLInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003676
Page 144 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sympt
om Pr
esent:NO
4.f Symptoms:
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED
SORE THR
OAT
Sympt
om Pr
esent:NOInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003677
Page 145 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.g Symptoms:
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARR
HEA
Symptom
Present:NOInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003678
Page 146 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.h Symptoms:
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMI
TING
Symptom
Present:NOInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003679
Page 147 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.i Symptoms:
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-17-2020
12:57:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Dec-17-2020
12:58:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms
- Other:Abdomi
nal painInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Dec-17-2020
12:58:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Abdominal painInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003680
Page 148 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Dec-17-2020
12:59:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003681
Page 149 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Dec-17-2020
12:59:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/15/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Dec-17-2020
12:59:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SWABBED MATERI
ALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Dec-17-2020
12:59:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Dec-17-2020
12:59:28ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003682
Page 150 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresP SYNDROME CORO
NAVIRUS 2
5. Device Type:
Date Location User Value Reason
Dec-17-2020
12:59:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGN
OSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Dec-17-2020
12:59:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ATILA BIOSYSTE
MS IAMP COVID-1
9 DETECTION KITInitial Entry
7. Test Result:
Date Location User Value Reason
Dec-17-2020
12:59:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003683
Page 151 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - 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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020
12:59:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020
12:59:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020
12:59:54
(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
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003684
Page 152 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - 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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Dec-17-2020
12:59:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample collected by t
eam physician.Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003685
Page 153 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: 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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020
13:01:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020
13:01:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020
10:32:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Dec-18-2020
06:36:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003686
Page 154 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: 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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Dec-17-2020
13:01:00
(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-17-2020
13:01:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/15/2020Initial Entry
5.a
Date Location User Value Reason
Dec-18-2020
10:32:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPWT0
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-18-2020
10:32:52
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
BPWT0FInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003687
Page 155 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: 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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003688
Page 156 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:SPEC
IALI
ST
Occurrence
of Visits or C
ontacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003689
Page 157 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pr
actitioner:EMER
GENC
Y ROO
M
Occurrenc
e of Visits
or Contact
s:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003690
Page 158 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of P
ractitione
r:PRIMAR
Y CARE
PHYSICI
AN
Occurren
ce of Visi
ts or Con
tacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE P
HYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Dec-17-2020
13:01:13ACV0PFEINFP6000  Data Entry:
Type of Pra URGEInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003691
Page 159 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Airesctitioner: NT C
ARE
Occurrence
of Visits or
Contacts:NO
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of P
ractitione
r:TELEPH
ONE CO
NSULTA
TIONInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003692
Page 160 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Occurren
ce of Visi
ts or Con
tacts:NO
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONS
ULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:OT
HE
R
Occurrence of
Visits or Cont
acts:NOInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003693
Page 161 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Dec-17-2020
13:01:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003694
Page 162 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Dec-17-2020
13:01:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-
19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Jan-13-2021
12:40:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness
Diagnosis:
acute diverticuliti
s
Date of Diagnosis:
Dec/15/2020New
Information
Dec-17-2020
13:01:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003695
Page 163 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/15/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Dec-17-2020
13:01:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003696
Page 164 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/12/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-12-2021
15:31:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/12/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-12-2021
15:31:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003697
Page 165 of 184
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/12/2021Form: 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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-12-2021
15:32:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-12-2021
15:32:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-13-2021
10:27:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-13-2021
07:34:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003698
Page 166 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/12/2021Form: 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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Jan-12-2021
15:32:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-12-2021
15:32:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/12/2021Initial Entry
5.a
Date Location User Value Reason
Jan-13-2021
10:27:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRYT2
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-13-2021
10:27:42
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
BRYT2VInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003699
Page 167 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/12/2021Form: 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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
5.b
Date Location User Value Reason
Jan-13-2021
10:27:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRYT3
6Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-13-2021
10:27:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRYT36Initial Entry
5.c
Date Location User Value Reason
Jan-13-2021
10:34:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPTBZ
DInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003700
Page 168 of 184
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/12/2021Form: 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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.c Sample ID
Date Location User Value Reason
Jan-13-2021
10:34:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTBZDInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003701
Page 169 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003702
Page 170 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-14-2020
19:17:19
(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
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Pain in left heelInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-14-2020 ACV0PFEINFP6000  auto query Query 2: Closed Close Auto
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003703
Page 171 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
19:17:46
(UTC-03:00) City
of Buenos Aires(autoquery) Query
Oct-14-2020
19:17:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-14-2020
19:17:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/28/2020 10:00Transcription
Error
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For Pain in left
heel: Start date
28/Aug/2020 is
before
V1D1VX1L
visit date
22/Sep/2020.
Please review
and update as
appropriate.
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start date is
before Consent
Date 22/Sep
/2020.
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020 10:00Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003704
Page 172 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/28/2020 18:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial 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
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003705
Page 173 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-20-2020
16:32:02
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Marjorie
BuonannoQuery 1: Closed Response
satisfies
query
Oct-19-2020
17:41:07
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answere
dIt is not a
medical
history of
bone spur.
The adverse
event was
due to
phisical
exrtion
Oct-16-2020
06:55:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Deleted Unfreeze
done
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003706
Page 174 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-15-2020
14:46:01
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Marjorie
BuonannoQuery 2: Candidat
eGPD Clin:
DM please
unfreeze
med Hx page
so site can
add bone
spur to med
Hx page
Oct-15-2020
14:44:45
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Marjorie
BuonannoQuery 1: Opened GPD Clin:
Are you
reporting
medical
history of
bone spur? If
yes, add this
to medical
history page.
Thank you
Oct-14-2020
19:17:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to
study treatment(s
), this event is du
e to:
OTHER
If Other, speci
fy:
spur backgr
oundInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003707
Page 175 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003708
Page 176 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-14-2020
19:17:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003709
Page 177 of 184
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-11-2020
13:23:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-11-2020
13:23:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-11-2020
13:23:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003710
Page 178 of 184
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-02-2021
12:44:32
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Feb/2/2021Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003711
Page 179 of 184
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 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
Feb-02-2021
12:44:52
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Delete
dClose Auto
Query
Feb-02-2021
12:44:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candid
ateThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-02-2021
12:44:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participant is wi
lling to return fo
r Vaccination 3
Participant is:
eligible and
NOT confirm
ed to have reInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003712
Page 180 of 184
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
ceived only p
lacebo at Vac
cination 1/2
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003713
Page 181 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-02-2021
12:44:52
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Feb/2/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-02-2021
12:44:52
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBI
LITY FOR ADDI
TIONAL VACCIN
ATIONInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003714
Page 182 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-11-2020
13:23:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-23-2020
08:42:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-23-2020
08:39:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-11-2020
13:23:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/11/2020Initial Entry
Sep-23-2020
08:42:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/22/2020Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003715
Page 183 of 184
***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: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-23-2020
08:39:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/22/2020Initial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003716
Page 184 of 184
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441422 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020
11:14:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to Enabl
eInitial Entry
090177e196ae2eb5\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003717
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From: To: Subject: [EXTERNAL EMAIL] - FBI Public Affairs News Briefing Thursday, September 03, 2020 Importance: Normal Priority: Normal Sensitivity: None Mobile version and searchable archives available at fbi.bulletinin…
EFTA00267943 — Dear Ms Pearce,
Dear Ms Pearce, Yours sincerely, NUT Pl CASE sFC;K ccRRCPT ION cor-lfrimSioNER* ' PRA0e TO vi cri OCcomeNTE-13 EU I beNce or Cere4STRecTE.D CIISE Fur W,QOUJIN)Csi seNEY'rce-s _ t,wci_A; et-ic-NT cCRikePnc.N treigca ---7 …
EFTA00674918 — From: Sultan Bin Sulayem
From: Sultan Bin Sulayem To: Jeffrey Epstein <[email protected]> Subject: Fwd: FDA Approved a Potent and Pricey Cholesterol lowering drug today Date: Fri, 24 Jul 2015 20:37:24 +0000 Have you heard of this colestrol J…
Federal Writers' Project

[Mining Lore of Waldo]
WPI L. C. PROJE'CT UNIT e-Ife ,:f-S Accession n3. W 9.0 Date received /y 0 Consignment no. Shipped from Label Amount AA. Form -3 0.%Lee(7,e. Collection (or Type) Title.. Place of origin Date atel Project worker e Project…
[Robbins, Ill.--A folklore in the making]
Accession no. WPA L. C. PROJECT _ Form -3 UNIT s645 Date received 10/1U/40 Consignment no. 1 Shipped from *ash. Office Label Amount 21p Eakil:tril__Collection (or Type) Title Robbins I11, A folklore In zakta& Place of or…
[Show Business]
tt-X, //e STATE NAME OF WORKER ADDRESS DATE SUBJECT Forms to be Filled out for Each Interview FORMA Circumstances of Interview NEW YORK WAYNE WALDEN 51 Bank Street, New York November 10, 1938 SHOO! BUSINESS and SELECTION…