125742 S1 M5 CRF c4591001 1231 12314395

Document text

Page 1 of 273
***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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883060
Page 2 of 273
***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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883061
Page 3 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Demography
1.Subject ID [12314395]
2.Birth Date: /1991
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883062
Page 4 of 273
***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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883063
Page 5 of 273
***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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883064
Page 6 of 273
***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: 12314395 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: [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883065
Page 7 of 273
***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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883066
Page 8 of 273
***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: 12314395 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: [70.8]
3.Unit: kg
4.Height: [181.0]
5.Unit: cm
6.Body Mass Index: [21.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883067
Page 9 of 273
***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: 12314395 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: [69469]
3.Randomization Group: [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883068
Page 10 of 273
***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: 12314395 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 [BPTGFR]
5.bSample ID [BPTGFS]
5.cSample ID [BPTGFT]
5.dSample ID [BLBJPX]
5.eSample ID [BLBJPY]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883069
Page 11 of 273
***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: 12314395 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 [BPTF65]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883070
Page 12 of 273
***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: 12314395 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 10:13
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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883071
Page 13 of 273
***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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883072
Page 14 of 273
***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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883073
Page 15 of 273
***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: 12314395 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: [36.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883074
Page 16 of 273
***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: 12314395 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 [BP1RG1]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883075
Page 17 of 273
***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: 12314395 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 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883076
Page 18 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883077
Page 19 of 273
***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: 12314395 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/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 [BRVH1J]
5.bSample ID [BPW61D]
5.cSample ID [BRVH0N]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883078
Page 20 of 273
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883079
Page 21 of 273
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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 [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883080
Page 22 of 273
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883081
Page 23 of 273
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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 [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883082
Page 24 of 273
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883083
Page 25 of 273
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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 [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883084
Page 26 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883085
Page 27 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/7/2020
2.Date of First Symptom Started: Oct/6/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/11/2020
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? YES
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883086
Page 28 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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]
5.bSymptoms - Other Text: [odynophagia ]
5.cSymptoms - Other Text: [rhinorrhea]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883087
Page 29 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of
Collecti
onSpecimen Typ
eSpecimen Col
lection Locati
onAssay Code and Descript
ionDevice TypeForm Insta
nce
 1.Oct/7/20
20 RESPIRATOR
Y SECRETIO
NS NASOPHAR
YNX SEVERE ACUTE RESP
SYNDROME CORONAV
IRUS 2 SARS-COV-2 D
IAGNOSTIC T
EST Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883088
Page 30 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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/7/2020
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: [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883089
Page 31 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883090
Page 32 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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/7/2020
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 [BPXWY7]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883091
Page 33 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883092
Page 34 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883093
Page 35 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Treatment Ident
ifierCon Non-Drug Treatments Pre-
specifiedTreatme
ntTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883094
Page 36 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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?
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883095
Page 37 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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?NO
3.Toxicity Grade: 1
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883096
Page 38 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category of Clinical E
vent:Subcategory of Clinical
EventDiagnosis Obtai
nedToxicity Gra
deForm Instance
 1.        Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883097
Page 39 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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:
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883098
Page 40 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category for
Lab TestVendor
NameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883099
Page 41 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883100
Page 42 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Define
d IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883101
Page 43 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883102
Page 44 of 273
***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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883103
Page 45 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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: [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883104
Page 46 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883105
Page 47 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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 % [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883106
Page 48 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date Time of Assessm
entArterial Blood Gases Pa
O2FiO2 (Fraction of Inhaled Oxy
gen)Form Instance
 1.      Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883107
Page 49 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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):[ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883108
Page 50 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883109
Page 51 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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?
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883110
Page 52 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of Assessme
ntLocation of Assessme
ntImaging Metho
dOverall Assessme
ntForm Instance
 1.        Repeating Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883111
Page 53 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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:
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883112
Page 54 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/15/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883113
Page 55 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/15/2021
2.Date of First Symptom Started: Feb/13/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/16/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
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? YES
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883114
Page 56 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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: [Nasal Congestion]
5.bSymptoms - Other Text: [Rhinorrhea]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883115
Page 57 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of
Collectio
nSpecimen T
ypeSpecimen Col
lection Locati
onAssay Code and Descripti
onDevice TypeForm Insta
nce
 1.Feb/15/2
021 SWABBED
MATERIA
L NASOPHARY
NX SEVERE ACUTE RESP S
YNDROME CORONAVIR
US 2 SARS-COV-2 D
IAGNOSTIC TE
ST Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883116
Page 58 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 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: Feb/15/2021
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: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883117
Page 59 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 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 a team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883118
Page 60 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 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:
Feb/15/2021
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 [BRM8S3]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883119
Page 61 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883120
Page 62 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883121
Page 63 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Treatment Ident
ifierCon Non-Drug Treatments Pre-
specifiedTreatme
ntTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883122
Page 64 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 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?
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883123
Page 65 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 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?NO
3.Toxicity Grade: 1
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883124
Page 66 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category of Clinical E
vent:Subcategory of Clinical
EventDiagnosis Obtai
nedToxicity Gra
deForm Instance
 1.        Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883125
Page 67 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 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:
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883126
Page 68 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category for
Lab TestVendor
NameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883127
Page 69 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883128
Page 70 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Define
d IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883129
Page 71 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883130
Page 72 of 273
***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: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883131
Page 73 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 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: [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883132
Page 74 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883133
Page 75 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 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 % [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883134
Page 76 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date Time of Assessm
entArterial Blood Gases Pa
O2FiO2 (Fraction of Inhaled Oxy
gen)Form Instance
 1.      Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883135
Page 77 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 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):[ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883136
Page 78 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883137
Page 79 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 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?
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883138
Page 80 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of Assessme
ntLocation of Assessme
ntImaging Metho
dOverall Assessme
ntForm Instance
 1.        Repeating Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883139
Page 81 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 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:
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883140
Page 82 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/04/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883141
Page 83 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/04/2020Form: 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: 12314395 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:
Nov/4/2020
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 [BJ5NJM]
5.bSample ID [BPTC7T]
5.cSample ID [BJ5NHS]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883142
Page 84 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 2 -
Unscheduled Visit on Mar/18/2021Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/18/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883143
Page 85 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 2 -
Unscheduled Visit on Mar/18/2021Form: 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: 12314395 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/18/2021
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 [BR28T1]
5.bSample ID [BS1S4B]
5.cSample ID [BS1S4J]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883144
Page 86 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883145
Page 87 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unplanned Assessments
1.Assessments
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883146
Page 88 of 273
***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: 12314395 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/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883147
Page 89 of 273
***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: 12314395 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: [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883148
Page 90 of 273
***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: 12314395 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:
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883149
Page 91 of 273
***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: 12314395 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 [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883150
Page 92 of 273
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883151
Page 93 of 273
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12314395 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:
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883152
Page 94 of 273
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12314395 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?
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883153
Page 95 of 273
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883154
Page 96 of 273
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883155
Page 97 of 273
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883156
Page 98 of 273
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/10/2021
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883157
Page 99 of 273
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 12314395 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:
Feb/10/2021
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 [BRT8T4]
5.bSample ID [BR1PSS]
5.cSample ID [BRT8PJ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883158
Page 100 of 273
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 12314395 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:
Feb/10/2021
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 [BR1WCY]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883159
Page 101 of 273
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/24/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK2
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883160
Page 102 of 273
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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:
Feb/24/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMCR8]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883161
Page 103 of 273
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/06/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/6/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK4
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883162
Page 104 of 273
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/06/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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/6/2021
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 [BR1M24]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883163
Page 105 of 273
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/18/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/18/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK6
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883164
Page 106 of 273
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/18/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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/18/2021
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 [BP8820]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883165
Page 107 of 273
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/6/2021
2.Erroneous Visit
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883166
Page 108 of 273
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883167
Page 109 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Hemospermia  Sep/26/202
0 10:00 NO
End Date Time:
Sep/26/2020 10:05
 Repeating
Pages
 2.ADVERSE
EVENT 2  Exposure during pregnan
cy (female partner) Nov/12/202
0 08:00 YES  Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883168
Page 110 of 273
***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: 12314395 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)[Hemospermia]
4.Start Date Time: Sep/26/2020 10:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/26/2020 10:05
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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883169
Page 111 of 273
***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: 12314395 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?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[ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883170
Page 112 of 273
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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)[Exposure during pregnancy (female partner)]
4.Start Date Time: Nov/12/2020 08:00
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883171
Page 113 of 273
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883172
Page 114 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categ
oryMedication
ErrorStart D
ateIs the medication error St
ill OngoingStudy Medication Err
ors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883173
Page 115 of 273
***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: 12314395 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[ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883174
Page 116 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883175
Page 117 of 273
***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: 12314395 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: //
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883176
Page 118 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883177
Page 119 of 273
***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: 12314395 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?
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883178
Page 120 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883179
Page 121 of 273
***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: 12314395 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?
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883180
Page 122 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883181
Page 123 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883182
Page 124 of 273
***Confidential***
 
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883183
Page 125 of 273
***Confidential***
 
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Booster Dose Trigger Form
1.Select appropriate response -
Will the participant return for
consent/eligibility assessment
for the booster dose visit?
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883184
Page 126 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/6/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883185
Page 127 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883186
Page 128 of 273
***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: 12314395 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: [ ]
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883187
Page 129 of 273
***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: 12314395 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/15/2020
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883188
Page 130 of 273
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883189
Page 131 of 273
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883190
Page 132 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-27-2020 11:45:29 (UTC-03:00) City
of Buenos AiresNot Applicable
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883191
Page 133 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-27-2020 11:46:02 (UTC-03:00) City
of Buenos AiresNot Applicable
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883192
Page 134 of 273
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
6Jan-07-2021 16:53:41 (UTC-03:00) City
of Buenos AiresSantiago
CorradettiNot Applicable
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883193
Page 135 of 273
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-20-2021 11:38:34 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Tatiana
Estrada Approved Mar-19-2021 17:44:52 (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.
 N/A Mar-18-2021 16:00:08 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Carola
Baldoni Approved Mar-08-2021 15:13:28 (UTC-03:00) City
of Buenos AiresBOOK Signed
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883194
Page 136 of 273
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, CarolaBaldoni, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-25-2021 19:43:04 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-17-2021 21:01:57 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-16-2021 18:17:55 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria Beretta  Approved Feb-16-2021 12:57:32 (UTC-03:00) City
of Buenos AiresBOOK Signed
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883195
Page 137 of 273
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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.
Martina
Davalli N/A Feb-10-2021 11:17:19 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-04-2021 18:34:41 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-03-2021 11:21:14 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-21-2021 08:53:35 (UTC-03:00) City
of Buenos AiresBOOK Signed
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883196
Page 138 of 273
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-04-2021 10:15:47 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-05-2020 15:50:37 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-05-2020 09:50:00 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-04-2020 16:37:31 (UTC-03:00) City
of Buenos AiresBOOK Signed
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883197
Page 139 of 273
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-04-2020 11:28:22 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-23-2020 14:54:30 (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.
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883198
Page 140 of 273
***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: 12314395 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
11:44:51
(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
11:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883199
Page 141 of 273
***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: 12314395 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
11:45:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obt
ained
Aug/27/2020Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883200
Page 142 of 273
***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: 12314395 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
09:24:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12314395Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-27-2020
09:24:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1991Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020
11:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020
11:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A
) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883201
Page 143 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-27-2020
11:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883202
Page 144 of 273
***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: 12314395 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
11:45:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883203
Page 145 of 273
***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: 12314395 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
11:45:51
(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
11:45:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020
11:45:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883204
Page 146 of 273
***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: 12314395 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
11:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-27-2020
11:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
70.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-27-2020
11:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-27-2020
11:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
181.0Initial Entry
5. Unit:
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883205
Page 147 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-27-2020
11:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-27-2020
11:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.6Initial Entry
7.a
Date Location User Value Reason
Aug-27-2020
11:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identif
ier::1
Temperature: 36.6
Temperature
Unit:C
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-27-2020
11:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883206
Page 148 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-27-2020
11:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-27-2020
11:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-27-2020
11:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883207
Page 149 of 273
***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: 12314395 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
11:46:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-27-2020
11:46:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
69469Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883208
Page 150 of 273
***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: 12314395 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
11:46:45
(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
11:46:45
(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
13:23:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-27-2020
12:51:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-27-2020 ACV0PFEINFP6000  auto query Query 1: Candidate 'Sample
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883209
Page 151 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
11:46:45
(UTC-03:00) City of
Buenos Aires(autoquery) Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-27-2020
11:46:45
(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
13:23:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPTGFRInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
13:23:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPTGFRInitial Entry
5.b
Date Location User Value Reason
Aug-28-2020
13:23:36
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
Sample ID: BPTGFSInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883210
Page 152 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
5.b Sample ID
Date Location User Value Reason
Aug-28-2020
13:23:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPTGFSInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020
13:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPTGFTInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020
13:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPTGFTInitial Entry
5.d
Date Location User Value Reason
Aug-28-2020
19:10:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BLBJPXInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883211
Page 153 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.d Sample ID
Date Location User Value Reason
Aug-28-2020
19:10:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BLBJPXInitial Entry
5.e
Date Location User Value Reason
Aug-28-2020
19:10:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BLBJPYInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-28-2020
19:10:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BLBJPYInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883212
Page 154 of 273
***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: 12314395 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
11:46:53
(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
11:46:53
(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
16:58:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-27-2020
12:51:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-27-2020 ACV0PFEINFP6000  auto query Query 1: Candidate 'Sample
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883213
Page 155 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
11:46:53
(UTC-03:00) City of
Buenos Aires(autoquery) Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-27-2020
11:46:53
(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
16:58:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPTF65Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
16:58:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTF65Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883214
Page 156 of 273
***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: 12314395 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
11:47:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020
11:47:11 (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
11:47:11 (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
11:47:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020 10:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883215
Page 157 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-27-2020
11:47:11 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020
11:47:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-27-2020
11:47:11 (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
11:47:11 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial 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
11:47:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883216
Page 158 of 273
***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: 12314395 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
11:47:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLECT
ED FOR THIS SUBJECTInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883217
Page 159 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020
12:41:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0883218
Page 160 of 273
***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: 12314395 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
12:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020
12:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identif
ier::1
Temperature: 36.2
Temperature
Unit:C
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020
12:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020
12:42:02ACV0PFEINFP6000  Data Entry:
36.2Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0883219
Page 161 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00) City of
Buenos Aires
2.a Unit:
Date Location User Value Reason
Sep-18-2020
12:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020
12:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0883220
Page 162 of 273
***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: 12314395 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 10:39:27
(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 10:39:27
(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
10:39:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-16-2020
10:39:27
(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
10:39:27
(UTC-03:00) City ofACV0PFEINFP6000  Romina
BarreraData Entry:
YES
Date of Collection:Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883221
Page 163 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
Sep/15/2020
5.a
Date Location User Value Reason
Sep-16-2020
10:39:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BP1RG1Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020
10:39:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BP1RG1Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883222
Page 164 of 273
***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: 12314395 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
12:42:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 12:42:16
(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 12:42:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020
12:42:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/15/2020 17:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0883223
Page 165 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-18-2020 12:42:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020
12:42:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020 12:42:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020 12:42:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial 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
12:42:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0883224
Page 166 of 273
***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: 12314395 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-15-2020
17:34:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883225
Page 167 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 17:34:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 17:34:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
17:56:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-15-2020
17:34:12
(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-15-2020
17:34:12
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883226
Page 168 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
Oct/15/2020
5.a
Date Location User Value Reason
Oct-15-2020
17:56:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRVH1JInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020
17:56:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRVH1JInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020
18:00:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPW61DInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020
18:00:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPW61DInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883227
Page 169 of 273
***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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c
Date Location User Value Reason
Oct-15-2020
18:51:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRVH0NInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-15-2020
18:51:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRVH0NInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883228
Page 170 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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-14-2020
13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto
Query
Oct-13-2020
13:00:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms form
is missing.
Please review
and update as
appropriate.
Oct-12-2020
12:37:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-12-2020
12:37:08
(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.
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0883229
Page 171 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-12-2020
12:37:08
(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-12-2020
12:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Oct/7/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-12-2020 12:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883230
Page 172 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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-15-2020
08:52:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto
Query
Oct-15-2020
08:52:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/7/2020Transcription
Error
Oct-14-2020
13:06:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-14-2020
13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Date of
assessment is not
same as Date
Visit. Please
check and
correct.
Oct-14-2020
13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened All symptoms are
reported as Not
Present and there
is no Other
Symptom
reported. Please
review and
update as
appropriate.
Oct-14-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0883231
Page 173 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
13:05:31
(UTC-03:00) City of
Buenos AiresOct/9/2020
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-22-2020
09:07:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom R
esolved:
Oct/11/2020New Information
Oct-14-2020
13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEVE
R
Symptom Present
:NOInitial Entry
4.a Symptoms:
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0883232
Page 174 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCR
EASED COUG
H
Symptom
Present:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883233
Page 175 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.b Symptoms:
Date Location User Value Reason
Oct-14-2020 13:05:31
(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-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR INCRE
ASED SHORTNE
SS OF BREATH
Sympt
om Pre
sent:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883234
Page 176 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.c Symptoms:
Date Location User Value Reason
Oct-14-2020 13:05:31
(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-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILL
S
Symptom Present
:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883235
Page 177 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.d Symptoms:
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE
PAIN
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883236
Page 178 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.e Symptoms:
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED M
USCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW LOSS OF
TASTE OR SME
LL
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883237
Page 179 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.f Symptoms:
Date Location User Value Reason
Oct-14-2020 13:05:31
(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-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-21-2020
11:44:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCR
EASED SORE
THROAT
Sympto
m Prese
nt:YESTranscription
Error
Oct-14-2020
13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCR
EASED SORE
THROAT
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883238
Page 180 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.g Symptoms:
Date Location User Value Reason
Oct-14-2020 13:05:31
(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
Oct-21-2020
11:44:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESTranscription
Error
Oct-14-2020
13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRH
EA
Symptom Pres
ent:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883239
Page 181 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.h Symptoms:
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITI
NG
Symptom Pres
ent:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883240
Page 182 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.i Symptoms:
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-14-2020 13:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Oct-14-2020 13:06:21
(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
Oct-14-2020 13:06:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
headacheInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020
09:07:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - O
ther:odynoph
agiaTranscription
Error
(DELETED)
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0883241
Page 183 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-14-2020
13:06:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - O
ther:odynoph
agiaInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883242
Page 184 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.b Symptoms - Other Text:
Date Location User Value Reason
Oct-22-2020
15:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-22-2020
09:07:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
odynophagiaTranscription
Error
(DELETED)
Oct-22-2020
09:07:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Oct-21-2020
19:49:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opene
dCRA: please
delete this row
because this
symptoms is
already reported
in Row 4.g.
Thanks.
Oct-21-2020
11:45:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Changed data per
query
Oct-15-2020
17:28:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CRA: please
delete this row
and answer Yes
in row 4.g.
Thanks.
Oct-14-2020
13:06:54ACV0PFEINFP6000  Data Entry:
odynophagiaInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883243
Page 185 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00) City of
Buenos Aires
5.c
Date Location User Value Reason
Oct-14-2020 13:07:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - Oth
er:rhinorrh
eaInitial Entry
5.c Symptoms - Other Text:
Date Location User Value Reason
Oct-14-2020 13:07:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
rhinorrheaInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0883244
Page 186 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Oct-14-2020 12:38:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883245
Page 187 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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-14-2020 12:38:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-21-2020
19:02:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-21-2020
11:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Oct-21-2020
11:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RESPIRATORY SECRE
TIONSInitial Entry
Oct-15-2020
08:17:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: The
response for
Data item#2
and 6 are
missing. Kindly
review and
update.
3. Specimen Collection Location:
Date Location User Value Reason
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0883246
Page 188 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-14-2020 12:38:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-14-2020 12:38:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SY
NDROME CORONAVIRU
S 2Initial Entry
5. Device Type:
Date Location User Value Reason
Oct-14-2020 12:38:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTI
C TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Oct-15-2020
08:52:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ATILA BIOSYSTEMS IA
MP COVID-19 DETECTI
ON KITInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-14-2020 12:38:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883247
Page 189 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020 12:40:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 12:40:39
(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-14-2020 12:40:39
(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-14-2020 12:40:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
sample collected by teamInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883248
Page 190 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 12:37:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 12:37:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020
12:37:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-12-2020
12:37:25
(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.
Oct-12-2020
12:37:25
(UTC-03:00) City ofACV0PFEINFP6000  Romina
BarreraData Entry:
YES
Date of Collection:Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883249
Page 191 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
Oct/7/2020
5.a
Date Location User Value Reason
Oct-12-2020
12:37:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BPXWY7Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020
12:37:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BPXWY7Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883250
Page 192 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Oct-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practition
er:SPECI
ALIST
Occurrence of Vis
its or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practit
ioner:EMERGE
NCY ROO
MInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883251
Page 193 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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
Oct-14-2020 12:42:00
(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-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:PRIMARY
CARE PHY
SICIAN
Occurrence
of Visits or C
ontacts:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0883252
Page 194 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 12:42:00
(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-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Oct-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitio
ner:URGEN
T CARE
Occurrence of V
isits or Contacts:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883253
Page 195 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 12:42:00
(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-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:TELEPHON
E CONSULT
ATION
Occurrence
of Visits or C
ontacts:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883254
Page 196 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTA
TIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner
:OTH
ER
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883255
Page 197 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-14-2020 12:42:00
(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-14-2020 12:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883256
Page 198 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 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-14-2020 12:45:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 IL
LNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Oct-14-2020 12:45:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-15-2020
08:53:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-15-2020
08:53:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Transcription
Error
Oct-14-2020
13:06:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Per CRF CRs
Section 8.33.5,
please enter
worst toxicity
grade (1 to 5) as
it relates to
reported
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883257
Page 199 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
symptom(s) on
SOD CRF. Please
review and
update as
appropriate.
Oct-14-2020
12:45:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
0Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883258
Page 200 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-16-2021
18:21:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Feb-16-2021
18:17:53
(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.
Feb-16-2021
18:17:53
(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.
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883259
Page 201 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Feb-16-2021
18:17:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/15/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-16-2021 18:17:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_BInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883260
Page 202 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/15/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/13/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-16-2021
18:20:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom R
esolved:
Feb/16/2021New Information
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.a
Date Location User Value Reason
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883261
Page 203 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEVE
R
Symptom Presen
t:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INC
REASED COU
GH
Sympto
m Prese
nt:YESInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883262
Page 204 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.b Symptoms:
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED C
OUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR INCRE
ASED SHORTN
ESS OF BREAT
H
Sympt
om Pr
esent:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883263
Page 205 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.c Symptoms:
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED S
HORTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILL
S
Symptom Prese
nt:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883264
Page 206 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.d Symptoms:
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCR
EASED MUSC
LE PAIN
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883265
Page 207 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.e Symptoms:
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED M
USCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW LOSS OF
TASTE OR SM
ELL
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883266
Page 208 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.f Symptoms:
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE O
R SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCR
EASED SORE T
HROAT
Sympto
m Prese
nt:YESInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883267
Page 209 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.g Symptoms:
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED S
ORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRH
EA
Symptom Pres
ent:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883268
Page 210 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.h Symptoms:
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITI
NG
Symptom Pres
ent:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883269
Page 211 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.i Symptoms:
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-16-2021
18:19:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Feb-16-2021
18:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms -
Other:Nasal Cong
estionInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Feb-16-2021
18:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nasal CongestionInitial Entry
5.b
Date Location User Value Reason
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883270
Page 212 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Feb-17-2021
09:26:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - Ot
her:Rhinorr
heaTranscription
Error
Feb-16-2021
18:19:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - Ot
her:Secreti
onInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883271
Page 213 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.b Symptoms - Other Text:
Date Location User ValueReason
Feb-17-2021
10:30:43
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Clo
sedDiscrepancy
has been
closed.
Feb-17-2021
09:26:00
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription
Error
Feb-17-2021
09:26:00
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
Rhino
rrheaTranscription
Error
Feb-16-2021
21:49:17
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Op
enedClarify the
term
SECRETION
as
follows...the
term appears
incomplete.
Are you
reporting
GASTRIN
SECRETION
DISORDER ?
Or
INCREASED
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883272
Page 214 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
BRONCHIAL
SECRETION
? or other? if
so please edit
to such.
Otherwise
please clarify
the term
further. Thank
you.
Feb-16-2021
18:19:45
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
Secret
ionInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883273
Page 215 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Feb-16-2021 18:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883274
Page 216 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 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
Feb-16-2021
18:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/15/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-16-2021
18:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-16-2021
18:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-16-2021 18:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SY
NDROME CORONAVIRU
S 2Initial Entry
5. Device Type:
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883275
Page 217 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Feb-16-2021 18:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTI
C TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-16-2021
18:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ATILA BIOSYSTEMS IA
MP COVID-19 DETECTI
ON KITInitial Entry
7. Test Result:
Date Location User Value Reason
Feb-16-2021
18:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883276
Page 218 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-16-2021 18:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-16-2021 18:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-16-2021
18:21:01
(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
Feb-16-2021
18:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample collected by a team
physicianInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883277
Page 219 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-16-2021 18:21:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-16-2021 18:21:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-17-2021
11:01:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-17-2021
08:07:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Feb-16-2021
18:21:11
(UTC-03:00) City ofACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0883278
Page 220 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: 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: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires barcodes are
entered. Please
review and
correct as
appropriate.
Feb-16-2021
18:21:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/15/2021Initial Entry
5.a
Date Location User Value Reason
Feb-17-2021
11:01:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRM8S3Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-17-2021
11:01:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRM8S3Initial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883279
Page 221 of 273
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitio
ner:SPECI
ALIST
Occurrence of Vi
sits or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:EMERGE
NCY RO
OMInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883280
Page 222 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Occurrence of
Visits or Cont
acts:NO
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pra
ctitioner:PRIMARY
CARE PHY
SICIAN
Occurrence
of Visits or
Contacts:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883281
Page 223 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSI
CIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:URGEN
T CARE
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883282
Page 224 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pra
ctitioner:TELEPHO
NE CONSU
LTATION
Occurrence
of Visits or
Contacts:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883283
Page 225 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULT
ATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitione
r:OTH
ER
Occurrence of Visi
ts or Contacts:NOInitial Entry
090177e196ae2ec4\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883284
Page 226 of 273
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/15/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314395 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-16-2021
18:22:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Da
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