125742 S1 M5 CRF c4591001 1231 12314583

Document text

Page 1 of 275
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884633
Page 2 of 275
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/27/2020
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884634
Page 3 of 275
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Demography
1.Subject ID [12314583]
2.Birth Date: /1999
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884635
Page 4 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884636
Page 5 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884637
Page 6 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884638
Page 7 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884639
Page 8 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [52.0]
3.Unit: kg
4.Height: [153.0]
5.Unit: cm
6.Body Mass Index: [22.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884640
Page 9 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/27/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884641
Page 10 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [70872]
3.Randomization Group: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884642
Page 11 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BPTG57]
5.bSample ID [BPTG58]
5.cSample ID [BPTG59]
5.dSample ID [BLBJJ3]
5.eSample ID [BLBJJ4]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884643
Page 12 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BPT9YT]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884644
Page 13 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 17:10
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
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884645
Page 14 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884646
Page 15 of 275
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884647
Page 16 of 275
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884648
Page 17 of 275
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/15/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884649
Page 18 of 275
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/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 [BP1RJ3]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884650
Page 19 of 275
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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/15/2020 18:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884651
Page 20 of 275
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884652
Page 21 of 275
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLBKR7]
5.bSample ID [BLBGYB]
5.cSample ID [BP1PM1]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884653
Page 22 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884654
Page 23 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/20/2020
2.Date of First Symptom Started: Oct/18/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/19/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
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
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884655
Page 24 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884656
Page 25 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of
Collectio
nSpecimen Typ
eSpecimen Col
lection Locati
onAssay Code and Descripti
onDevice TypeForm Insta
nce
 1.Oct/20/2
020 RESPIRATOR
Y SECRETIO
NS NASOPHARY
NX SEVERE ACUTE RESP S
YNDROME CORONAVIR
US 2 SARS-COV-2 DI
AGNOSTIC TE
ST Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884657
Page 26 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/20/2020
2.Specimen Type: RESPIRATORY SECRETIONS
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: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884658
Page 27 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884659
Page 28 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BPT7WP]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884660
Page 29 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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:YES
Number of Visits or Contacts:
[1]
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
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884661
Page 30 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884662
Page 31 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884663
Page 32 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884664
Page 33 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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:
[Gastroenteritis]
Date of Diagnosis:
Oct/21/2020
3.Toxicity Grade: 1
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884665
Page 34 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category of Clinical Ev
ent:Subcategory of Clinical E
ventDiagnosis Obtai
nedToxicity Gra
deForm Instance
 1.        Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884666
Page 35 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884667
Page 36 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884668
Page 37 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884669
Page 38 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.       Sponsor-Define
d IdentifierTes
t:Res
ult:Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884670
Page 39 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884671
Page 40 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884672
Page 41 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884673
Page 42 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884674
Page 43 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884675
Page 44 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date Time of Assessme
ntArterial Blood Gases Pa
O2FiO2 (Fraction of Inhaled Oxyg
en)Form Instance
 1.      Repeating Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884676
Page 45 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884677
Page 46 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart
DateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884678
Page 47 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884679
Page 48 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of Assessmen
tLocation of Assessmen
tImaging Metho
dOverall Assessmen
tForm Instance
 1.        Repeating Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884680
Page 49 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884681
Page 50 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884682
Page 51 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/27/2021
2.Date of First Symptom Started: Jan/26/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/3/2021
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
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884683
Page 52 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884684
Page 53 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of
Collectio
nSpecimen T
ypeSpecimen Coll
ection Locatio
nAssay Code and Descriptio
nDevice TypeForm Insta
nce
 1.Jan/27/20
21 SWABBED
MATERIAL
 NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRU
S 2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884685
Page 54 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/27/2021
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: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884686
Page 55 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884687
Page 56 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/27/2021
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 [BPW6JB]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884688
Page 57 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884689
Page 58 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884690
Page 59 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884691
Page 60 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884692
Page 61 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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:
[Mild COVID-19 illness]
Date of Diagnosis:
Jan/27/2021
3.Toxicity Grade: 1
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884693
Page 62 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category of Clinical Ev
ent:Subcategory of Clinical E
ventDiagnosis Obtai
nedToxicity Gra
deForm Instance
 1.        Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884694
Page 63 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884695
Page 64 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884696
Page 65 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884697
Page 66 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.       Sponsor-Define
d IdentifierTes
t:Res
ult:Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884698
Page 67 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884699
Page 68 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884700
Page 69 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884701
Page 70 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884702
Page 71 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884703
Page 72 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date Time of Assessme
ntArterial Blood Gases Pa
O2FiO2 (Fraction of Inhaled Oxyg
en)Form Instance
 1.      Repeating Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884704
Page 73 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884705
Page 74 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart
DateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884706
Page 75 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884707
Page 76 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of Assessmen
tLocation of Assessmen
tImaging Metho
dOverall Assessmen
tForm Instance
 1.        Repeating Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884708
Page 77 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884709
Page 78 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/19/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884710
Page 79 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/19/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/19/2021
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 [BRYTCF]
5.bSample ID [BRYTCG]
5.cSample ID [BRYT9J]
5.dSample ID [BPWBF6]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884711
Page 80 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 2 -
Unscheduled Visit on Mar/05/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884712
Page 81 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 2 -
Unscheduled Visit on Mar/05/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/5/2021
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 [BR22Z6]
5.bSample ID [BLBHC7]
5.cSample ID [BLBHDG]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884713
Page 82 of 275
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884714
Page 83 of 275
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unplanned Assessments
1.Assessments
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884715
Page 84 of 275
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884716
Page 85 of 275
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884717
Page 86 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB -
New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884718
Page 87 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB -
New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884719
Page 88 of 275
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884720
Page 89 of 275
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884721
Page 90 of 275
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884722
Page 91 of 275
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884723
Page 92 of 275
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884724
Page 93 of 275
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884725
Page 94 of 275
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884726
Page 95 of 275
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884727
Page 96 of 275
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/13/2021
2.Erroneous Visit
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884728
Page 97 of 275
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/13/2021
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884729
Page 98 of 275
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884730
Page 99 of 275
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Mar/13/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884731
Page 100 of 275
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/13/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884732
Page 101 of 275
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/13/2021
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 [BPT659]
5.bSample ID [BRYH4B]
5.cSample ID [BRYH2V]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884733
Page 102 of 275
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/13/2021
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 [BR1LKT]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884734
Page 103 of 275
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/13/2021 16:17
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884735
Page 104 of 275
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884736
Page 105 of 275
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884737
Page 106 of 275
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884738
Page 107 of 275
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884739
Page 108 of 275
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884740
Page 109 of 275
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884741
Page 110 of 275
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884742
Page 111 of 275
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884743
Page 112 of 275
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884744
Page 113 of 275
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884745
Page 114 of 275
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884746
Page 115 of 275
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#CategoryAE Identi
fierAdverse Eve
ntStart DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Epigastralgia
 Oct/15/2020 0
6:30 NO
End Date Time:
Oct/19/2020 17:00
 Repeating
Pages
 2.ADVERSE EV
ENT 2  acute pancrea
titis Nov/30/2020 2
2:00 NO
End Date Time:
Dec/14/2020 18:00
 Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884747
Page 116 of 275
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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)[Epigastralgia]
4.Start Date Time: Oct/15/2020 06:30
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/19/2020 17:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884748
Page 117 of 275
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
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[ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884749
Page 118 of 275
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[acute pancreatitis]
4.Start Date Time: Nov/30/2020 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/14/2020 18:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884750
Page 119 of 275
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?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[2020478859]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884751
Page 120 of 275
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Catego
ryMedication
ErrorStart D
ateIs the medication error Sti
ll OngoingStudy Medication Erro
rs ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884752
Page 121 of 275
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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[ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884753
Page 122 of 275
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart
DateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884754
Page 123 of 275
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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: //
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884755
Page 124 of 275
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884756
Page 125 of 275
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884757
Page 126 of 275
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Catego
ryTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884758
Page 127 of 275
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884759
Page 128 of 275
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884760
Page 129 of 275
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884761
Page 130 of 275
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/10/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884762
Page 131 of 275
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884763
Page 132 of 275
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884764
Page 133 of 275
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/19/2020
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884765
Page 134 of 275
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884766
Page 135 of 275
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Yanina Rivera  Approved Mar-16-2021 18:02:07 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, YaninaRivera, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884767
Page 136 of 275
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-27-2020 18:22:16 (UTC-03:00) City
of Buenos AiresNot Applicable
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884768
Page 137 of 275
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-27-2020 18:22:48 (UTC-03:00) City
of Buenos AiresNot Applicable
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884769
Page 138 of 275
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormMar-14-2021 10:31:26 (UTC-03:00) City
of Buenos AiresNot Applicable
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884770
Page 139 of 275
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Yanina Rivera  Approved Mar-16-2021 18:02:07 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, YaninaRivera, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-10-2021 12:48:23 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria Beretta  Approved Mar-09-2021 19:31:13 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, MariaBeretta, 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.
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884771
Page 140 of 275
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Martina
Davalli N/A Mar-05-2021 10:43:51 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-09-2021 17:41:56 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-05-2021 11:16:11 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Tatiana
Estrada Approved Jan-29-2021 15:13:22 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, TatianaEstrada, 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.
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884772
Page 141 of 275
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
 N/A Jan-28-2021 13:20:45 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-21-2021 08:42:17 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-03-2020 12:23:24 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-28-2020 19:28:08 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884773
Page 142 of 275
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
 N/A Oct-27-2020 10:04:36 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-23-2020 18:52:01 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884774
Page 143 of 275
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-27-2020 18:20:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-27-2020 18:20:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884775
Page 144 of 275
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-27-2020 18:21:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Aug/27/2020Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884776
Page 145 of 275
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-27-2020 16:14:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12314583Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-27-2020 16:14:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1999Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020 18:21:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020 18:21:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-27-2020 18:21:34
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0884777
Page 146 of 275
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0884778
Page 147 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020 18:21:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884779
Page 148 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-27-2020 18:22:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020 18:22:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020 18:22:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884780
Page 149 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020 18:23:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-27-2020 18:23:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
52.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-27-2020 18:23:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-27-2020 18:23:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
153.0Initial Entry
5. Unit:
Date Location User Value Reason
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884781
Page 150 of 275
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-27-2020 18:23:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-27-2020 18:23:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22.2Initial Entry
7.a
Date Location User Value Reason
Aug-27-2020 18:23:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifi
er::1
Temperature: 36.7
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-27-2020 18:23:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-27-2020 18:23:29
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
36.7Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0884782
Page 151 of 275
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
7.a Unit:
Date Location User Value Reason
Aug-27-2020 18:23:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-27-2020 18:23:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0884783
Page 152 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-27-2020 18:23:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-27-2020 18:23:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-27-2020 18:23:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-27-2020 18:23:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-27-2020 18:23:40
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884784
Page 153 of 275
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
6.a
Date Location User Value Reason
Aug-27-2020 18:23:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-27-2020 18:23:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-27-2020 18:23:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-27-2020 18:23:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0884785
Page 154 of 275
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884786
Page 155 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-27-2020 18:23:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-27-2020 18:23:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
70872Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884787
Page 156 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 18:24:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 18:24:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
16:02:36 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020
02:25:34 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-27-2020
18:24:06 (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
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884788
Page 157 of 275
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
correct as
appropriate.
Aug-27-2020
18:24:06 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
16:02:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BPTG57Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
16:02:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPTG57Initial Entry
5.b
Date Location User Value Reason
Aug-28-2020
16:02:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BPTG58Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884789
Page 158 of 275
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.b Sample ID
Date Location User Value Reason
Aug-28-2020
16:02:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPTG58Initial Entry
5.c
Date Location User Value Reason
Aug-28-2020
16:02:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BPTG59Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020
16:02:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPTG59Initial Entry
5.d
Date Location User Value Reason
Aug-28-2020
17:29:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BLBJJ3Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884790
Page 159 of 275
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.d Sample ID
Date Location User Value Reason
Aug-28-2020
17:29:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BLBJJ3Initial Entry
5.e
Date Location User Value Reason
Aug-28-2020
17:29:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BLBJJ4Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-28-2020
17:29:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BLBJJ4Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884791
Page 160 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 18:24:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 18:24:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
11:25:15 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020
02:25:34 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-27-2020
18:24:14 (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
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884792
Page 161 of 275
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
correct as
appropriate.
Aug-27-2020
18:24:14 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
11:25:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT9YTInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
11:25:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT9YTInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884793
Page 162 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-27-2020 18:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020 18:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020 18:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-27-2020 18:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020 17:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020 18:24:33
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884794
Page 163 of 275
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
6. Body Side:
Date Location User Value Reason
Aug-27-2020 18:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-27-2020 18:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-27-2020 18:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-27-2020 18:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884795
Page 164 of 275
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-27-2020 18:24:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E
-DIARY NOT COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884796
Page 165 of 275
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-23-2020
05:10:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed COVID illness
visit updated per
query
Oct-22-2020
08:59:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered COVID illness
visit was done,
information was
uploaded Thank
you
Oct-19-2020
12:58:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Illness ediary: As
per Illness ediary
records, subject
reported "Yes" for
the question
"Have you
experienced any
of the following?”
for the COVID-19
symptoms or
diagnosis on
15OCT2020. But
corresponding
COVID Illness
visit not reported.
Please clarify.
Sep-18-2020
17:53:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884797
Page 166 of 275
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 17:53:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 17:53:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifi
er::1
Temperature: 37.1
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 17:53:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 17:53:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
37.1Initial Entry
2.a Unit:
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884798
Page 167 of 275
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Sep-18-2020 17:53:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 17:53:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884799
Page 168 of 275
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020 17:54:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020 17:54:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020 17:54:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-18-2020 17:54:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020 17:54:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884800
Page 169 of 275
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
6.a
Date Location User Value Reason
Sep-18-2020 17:54:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-18-2020 17:54:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020 17:54:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020 17:54:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884801
Page 170 of 275
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 11:32:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 11:32:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020
11:32:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-16-2020
11:32:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-16-2020
11:32:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884802
Page 171 of 275
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a
Date Location User Value Reason
Sep-16-2020 11:32:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP1RJ3Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 11:32:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP1RJ3Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884803
Page 172 of 275
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 17:54:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 17:54:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 17:54:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 17:54:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/15/2020 18:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 17:54:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884804
Page 173 of 275
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
6. Body Side:
Date Location User Value Reason
Sep-18-2020 17:54:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020 17:54:25
(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-18-2020 17:54:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-18-2020 17:54:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884805
Page 174 of 275
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 17:20:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884806
Page 175 of 275
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 14:38:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 14:38:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 14:38:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 14:38:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-19-2020 14:38:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884807
Page 176 of 275
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a
Date Location User Value Reason
Oct-19-2020 14:38:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLBKR7Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020 14:38:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLBKR7Initial Entry
5.b
Date Location User Value Reason
Oct-19-2020 16:12:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BLBGYBInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020 16:12:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BLBGYBInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020 17:04:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP1PM1Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884808
Page 177 of 275
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Sample ID
Date Location User Value Reason
Oct-19-2020 17:04:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP1PM1Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884809
Page 178 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-05-2021
06:09:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Closed data updated
Mar-04-2021
15:36:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Query 3: Answered the subject has
the conva visit
scheduled for
05/MAR/2021,
thank you
Mar-04-2021
08:52:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Opened PDQ:
Convalescent
visit is missing
and 35+ days
(36) have passed
since COVID
Illness Visit. If
visit occurred
record data as a
matching
CONVA visit; if
visit did not
occur attempt to
schedule visit
even if OOW and
obtain the
CONVA sample
else clarify.
Oct-22-2020
08:55:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884810
Page 179 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-22-2020
08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Oct-22-2020
08:51:31
(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.
Oct-22-2020
08:51:31
(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 Nasal
Swab are
missing. Please
review and
update as
appropriate.
Oct-22-2020
08:51:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-22-2020 08:51:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884811
Page 180 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-02-2020
05:46:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Closed Per site
confirmation-was
not associated to
the covid visit
Oct-31-2020
19:27:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Answered the alarm activated
on October 15th
was the adverse
event of
epigastralgia. and
was not associated
to the covid visit
Oct-31-2020
05:10:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened Illness ediary: As
per Illness ediary
records, subject
reported "Yes" for
the COVID-19
symptoms or
diagnosis on
15OCT2020.
However symptom
start for this Covid
illness visit is
18Oct2020. Please
clarify if
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884812
Page 181 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
symptoms were
erroneously
reported on
15Oct2020.
Oct-22-2020
08:53:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/18/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Reso
lved:
Oct/19/2020Initial Entry
4.a
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884813
Page 182 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCR
EASED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED CO
UGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SHORTNESS
OF BREATHInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884814
Page 183 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sympto
m Pres
ent:NO
4.c Symptoms:
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SH
ORTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILL
S
Symptom Present
:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884815
Page 184 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.d Symptoms:
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE
PAIN
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884816
Page 185 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.e Symptoms:
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MU
SCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW LOSS OF T
ASTE OR SMEL
L
Sympto
m Presen
t:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884817
Page 186 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.f Symptoms:
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR
SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE TH
ROAT
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884818
Page 187 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.g Symptoms:
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SOR
E THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884819
Page 188 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.i
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-22-2020 08:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884820
Page 189 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Oct-22-2020 08:55:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884821
Page 190 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-22-2020 08:55:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-22-2020 08:55:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RESPIRATORY SECRETIO
NSInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-22-2020 08:55:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-22-2020 08:55:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Oct-22-2020 08:55:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC
TESTInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884822
Page 191 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
6. Trade Name:
Date Location User Value Reason
Oct-22-2020 08:55:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ATILA BIOSYSTEMS IAM
P COVID-19 DETECTION
KITInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-22-2020 08:55:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884823
Page 192 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 08:55:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 08:55:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 08:55:28
(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
Oct-22-2020 08:55:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample collected by team ph
ysicianInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884824
Page 193 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 08:55:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 08:55:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 10:13:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 08:55:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-22-2020 08:55:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884825
Page 194 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a
Date Location User Value Reason
Oct-22-2020 10:13:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT7WPInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 10:13:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT7WPInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884826
Page 195 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practition
er:SPECI
ALIST
Occurrence of Visi
ts or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:EMERGENC
Y ROOMInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884827
Page 196 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Occurrence
of Visits or C
ontacts:YES
Number of V
isits or Cont
acts:
1
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contact
s:
1Initial Entry
1.c
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pract
itioner:PRIMARY C
ARE PHYSI
CIAN
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884828
Page 197 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICI
ANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitio
ner:URGEN
T CARE
Occurrence of Vi
sits or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884829
Page 198 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.e
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pract
itioner:TELEPHON
E CONSULT
ATION
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTAT
IONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884830
Page 199 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-22-2020 08:56:51
(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
Oct-22-2020 08:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884831
Page 200 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-22-2020 08:58:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILL
NESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Oct-27-2020
16:51:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-27-2020
10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-27-2020
10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Dia
gnosis:
Gastroenteritis
Date of Diagnosis:
Oct/21/2020Transcription Error
Oct-26-2020
17:33:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opene
dCRA: please verify
according to
medical chart:
there is mentioned
Gastroenteritis.
Please correct
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884832
Page 201 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Thanks.
Oct-26-2020
16:16:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Original value is
correct
Oct-24-2020
20:58:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Per clinical chart
the subject has
"gastroenteritis".
Please review
chart and update if
necessary. Thanks
Oct-22-2020
08:58:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Dia
gnosis:
Stomach flu
Date of Diagnosis:
Oct/21/2020Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-22-2020 08:58:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884833
Page 202 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021 13:23:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-28-2021 13:20:43
(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.
Jan-28-2021 13:20:43
(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 Nasal Swab
are missing.
Please review and
update as
appropriate.
Jan-28-2021 13:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0884834
Page 203 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-28-2021 13:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_BInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884835
Page 204 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/26/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-05-2021 11:16:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Res
olved:
Feb/3/2021New Information
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884836
Page 205 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires Symptoms: FEVER
Symptom Present: YES
4.a Symptoms:
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCR
EASED COUGH
Symptom
Present:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0884837
Page 206 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.b Symptoms:
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED CO
UGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SHORTNESS
OF BREATH
Sympto
m Pres
ent:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884838
Page 207 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.c Symptoms:
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SH
ORTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILL
S
Symptom Present
:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884839
Page 208 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.d Symptoms:
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE
PAIN
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884840
Page 209 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.e Symptoms:
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MU
SCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW LOSS OF T
ASTE OR SMEL
L
Sympto
m Presen
t:YESInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884841
Page 210 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.f Symptoms:
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR
SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.g
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE TH
ROAT
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884842
Page 211 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.g Symptoms:
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SO
RE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884843
Page 212 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.h Symptoms:
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884844
Page 213 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.i Symptoms:
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-28-2021 13:21:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Jan-28-2021 13:21:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - Othe
r:Headach
eInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Jan-28-2021 13:21:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884845
Page 214 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Jan-28-2021 13:22:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884846
Page 215 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Jan-28-2021 13:22:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-28-2021 13:22:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-28-2021 13:22:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Jan-28-2021 13:22:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884847
Page 216 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Jan-28-2021 13:22:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC
TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Jan-28-2021 13:22:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ATILA BIOSYSTEMS IAM
P COVID-19 DETECTION
KITInitial Entry
7. Test Result:
Date Location User Value Reason
Jan-28-2021 13:22:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
POSITIVEInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884848
Page 217 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-28-2021 13:22:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-28-2021 13:22:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-28-2021 13:22:52
(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
Jan-28-2021 13:22:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample collected by team ph
ysicianInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884849
Page 218 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-28-2021 13:23:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-28-2021 13:23:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-28-2021 15:47:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-28-2021 13:23:04
(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-28-2021 13:23:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/27/2021Initial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884850
Page 219 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a
Date Location User Value Reason
Jan-28-2021 15:47:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPW6JBInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-28-2021 15:47:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPW6JBInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884851
Page 220 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practition
er:SPECI
ALIST
Occurrence of Visi
ts or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:EMERGE
NCY ROO
MInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884852
Page 221 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Occurrence of
Visits or Conta
cts:NO
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pract
itioner:PRIMARY C
ARE PHYSI
CIAN
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884853
Page 222 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICI
ANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitio
ner:URGEN
T CARE
Occurrence of Vi
sits or Contacts:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884854
Page 223 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pract
itioner:TELEPHON
E CONSULT
ATION
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884855
Page 224 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTAT
IONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884856
Page 225 of 275
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-28-2021 13:23:22
(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
Jan-28-2021 13:23:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2ead\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884857
Page 226 of 275
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/27/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314583 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Jan-28-2021 13:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  a
…[truncated]