Document text
Page 1 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 version30 JUN 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874735
Page 2 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/23/2020
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874736
Page 3 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Demography
1.Subject ID [12313496]
2.Birth Date: /1950
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874737
Page 4 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/23/2020
2.Erroneous Visit
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874738
Page 5 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion
criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55
years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years,
inclusive, at randomization (dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all
scheduled visits, vaccination plan, laboratory tests, lifestyle
considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN02A00
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874739
Page 6 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history,
physical examination, and clinical judgment of the investigator
to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which
includes compliance with the requirements and restrictions
listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past
year) or active suicidal ideation/behavior/lab abnormality that
may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX01A00
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874740
Page 7 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine
and/or severe allergic reaction (eg, anaphylaxis) to any
component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX04A00
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874741
Page 8 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or
laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged
bleeding that would, in the opinion of the investigator,
contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX11A00
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874742
Page 9 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as
cytotoxic agents or systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60
days before study intervention administration or planned
receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX14A01
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874743
Page 10 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention
within 28 days prior to study entry and/or during study
participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study
intervention containing lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in
the conduct of the study, site staff otherwise supervised by the
investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX21A01
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874744
Page 11 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/23/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874745
Page 12 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874746
Page 13 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vital Signs
1.Date: Aug/23/2020
2.Weight: [115.0]
3.Unit: kg
4.Height: [181.0]
5.Unit: cm
6.Body Mass Index: [35.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874747
Page 14 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/23/2020
2.Randomization Number: [237590]
3.Randomization Group: [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874748
Page 15 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/23/2020
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 [BNTNFD]
5.bSample ID [BNTNFF]
5.cSample ID [BP24C4]
5.dSample ID [BP24C5]
5.eSample ID [BP24C6]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874749
Page 16 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/23/2020
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 [BP26G4]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874750
Page 17 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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/23/2020 15:35
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
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874751
Page 18 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874752
Page 19 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874753
Page 20 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874754
Page 21 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [BP1RDX]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874755
Page 22 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 17:05
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
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874756
Page 23 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874757
Page 24 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWDJD]
5.bSample ID [BLBH44]
5.cSample ID [BLBH2L]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874758
Page 25 of 258
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/20/2021
2.Erroneous Visit
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874759
Page 26 of 258
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/20/2021
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 [BS1V6G]
5.bSample ID [BR1YS2]
5.cSample ID [BS1V67]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874760
Page 27 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874761
Page 28 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874762
Page 29 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874763
Page 30 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874764
Page 31 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874765
Page 32 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/12/2020
2.Date of First Symptom
Started:Nov/11/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/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
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874766
Page 33 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [asthenia]
5.bSymptoms - Other Text: [abdominal pain]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874767
Page 34 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
1.Nov/12/
2020 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874768
Page 35 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/12/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASOPHARYNX
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874769
Page 36 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[sample collected by team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874770
Page 37 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/12/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPT858]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874771
Page 38 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874772
Page 39 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874773
Page 40 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874774
Page 41 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874775
Page 42 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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: 2
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874776
Page 43 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1. Repeating
Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874777
Page 44 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874778
Page 45 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1. Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874779
Page 46 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874780
Page 47 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
1. Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874781
Page 48 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874782
Page 49 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874783
Page 50 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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:[ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874784
Page 51 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874785
Page 52 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874786
Page 53 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1. Repeating
Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874787
Page 54 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874788
Page 55 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874789
Page 56 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874790
Page 57 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1. Repeating
Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874791
Page 58 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874792
Page 59 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/15/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874793
Page 60 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/15/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/15/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRVPBS]
5.bSample ID [BPWT04]
5.cSample ID [BRVPCB]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874794
Page 61 of 258
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874795
Page 62 of 258
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Unplanned Assessments
1.Assessments
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874796
Page 63 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874797
Page 64 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874798
Page 65 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874799
Page 66 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874800
Page 67 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874801
Page 68 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874802
Page 69 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874803
Page 70 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874804
Page 71 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874805
Page 72 of 258
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874806
Page 73 of 258
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874807
Page 74 of 258
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874808
Page 75 of 258
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874809
Page 76 of 258
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874810
Page 77 of 258
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874811
Page 78 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Categor
yAE Id
entifie
rAdverse EventStart D
ateIs the Adverse E
vent Still Ongoi
ngForm Insta
nce
1.ADVER
SE EVE
NT 1 LEFT INFRACLAVICULA
R ADENOPATHY, 5 mm IN
DIAMETER. Sep/17/
2020 18:
00 NO
End Date Time:
Sep/24/2020
09:00
Repeating
Pages
2.ADVER
SE EVE
NT 2 Arterial hypertension Oct/24/2
020 20:0
0 NO
End Date Time:
Oct/25/2020 2
2:00
Repeating
Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874812
Page 79 of 258
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[LEFT INFRACLAVICULAR ADENOPATHY, 5 mm IN
DIAMETER.]
4.Start Date Time: Sep/17/2020 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/24/2020 09:00
6.Toxicity Grade: 1
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874813
Page 80 of 258
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874814
Page 81 of 258
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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[ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874815
Page 82 of 258
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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)[Arterial hypertension]
4.Start Date Time: Oct/24/2020 20:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/25/2020 22:00
6.Toxicity Grade: 1
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874816
Page 83 of 258
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874817
Page 84 of 258
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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[ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874818
Page 85 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category Medication ErrorStart
DateIs the medication
error Still Ongoi
ngStudy Medica
tion Errors A
ctionForm Insta
nce
1.MEDICAT
ION ERR
OR Wrong IP dose. sub
ject received 58mc
g of iP Aug/2
3/202
0 NO
End Date:
Aug/23/2020
NO ACTION
TAKEN Repeating
Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874819
Page 86 of 258
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Medication Error
1.Category: MEDICATION ERROR
2.Medication Error (Type of
Medication Error):[Wrong IP dose. subject received 58mcg of iP]
3.Start Date: Aug/23/2020
4.Is the medication error still
ongoing?NO
End Date:
Aug/23/2020
5.Latest Action Taken with
Study Treatment:NO ACTION TAKEN
6.Was a Concomitant
Medication given?NO
7.Was a Non-Drug Treatment
given?NO
8.Did the Medication Error
cause the subject to be
discontinued from the
study?NO
9.Was this medication error
associated with any adverse
events?NO
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874820
Page 87 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874821
Page 88 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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: //
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874822
Page 89 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874823
Page 90 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874824
Page 91 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874825
Page 92 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874826
Page 93 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874827
Page 94 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874828
Page 95 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874829
Page 96 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874830
Page 97 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Aug/31/2020
2.Primary Reason for
Unblinding:OTHER
If other, specify:
[Medication error. Subject received 58mcg of investigational
product.]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874831
Page 98 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874832
Page 99 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874833
Page 100 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/19/2020
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874834
Page 101 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874835
Page 102 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874836
Page 103 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
FormAug-23-2020 16:49:32 (UTC-03:00)
City of Buenos AiresMartina
DavalliNot Applicable
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874837
Page 104 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 17:31:53 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Vanesa
Fainboim Approved Jan-20-2021 18:37:05 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, VanesaFainboim, 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.
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874838
Page 105 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
N/A Dec-15-2020 14:36:48 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-14-2020 12:12:28 (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.
Martina
Davalli N/A Nov-13-2020 14:44:27 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-11-2020 19:01:21 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874839
Page 106 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Affidavit:
By my dated signature below, I, , verify that all case report form pages
accurately display the results of the examinations, tests, evaluations and treatments performed on
this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Nov-11-2020 11:44:47 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Nov-09-2020 16:03:39 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874840
Page 107 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Nov-08-2020 18:59:27 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-29-2020 18:25:43 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874841
Page 108 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 Oct-29-2020 15:08:34 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-27-2020 18:17:49 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874842
Page 109 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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.
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874843
Page 110 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-23-2020
16:47:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-23-2020
16:47:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874844
Page 111 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-23-2020
16:48:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/23/2020Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874845
Page 112 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-23-2020
15:02:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12313496Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-23-2020
15:02:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1950Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-23-2020
16:48:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-23-2020 ACV0PFEINFP6000 Martina Data Entry: Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874846
Page 113 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
16:48:17
(UTC-03:00) City
of Buenos AiresDavalli HISPANIC OR LAT
INO(A) OR OF SPA
NISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-23-2020
16:48:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
WHITEInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874847
Page 114 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020
08:57:55
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Closed Per site
confirmation
Not COVID
RELATED
Oct-14-2020
10:57:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Answere
dAccording to
the medical
records at the
time of
communication
with the subject,
he refers to
being
asymptomatic.
ALARM was
not related to
probable
COVID-19
disease. Thank
you.
Oct-02-2020
06:20:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Balaji Prabu
R Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have
you experienced
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874848
Page 115 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
any of the
following?” for
the COVID-19
symptoms or
diagnosis on
30Aug2020. But
there is no
COVID Illness
visit reported in
the database.
Please clarify.
Aug-23-2020
16:48:23
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/23/2020Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874849
Page 116 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.a
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Incl
usio
n N
um
ber:1
Crit
erio
n D
escr
ipti
on:Male or femal
e participants
between the ag
es of 18 and 5
5 years, inclusi
ve, 65 and 85
years, inclusiv
e, or 18 and 85
years, inclusiv
e, at randomiz
ation (depende
nt upon study
stage)
Crit
erio
n m
et?:YESInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874850
Page 117 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Male or female parti
cipants between the
ages of 18 and 55 ye
ars, inclusive, 65 and
85 years, inclusive, o
r 18 and 85 years, in
clusive, at randomiza
tion (dependent uponInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874851
Page 118 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
study stage)
1.a Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Incl
usio
n N
umb
er:2Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874852
Page 119 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n De
scri
ptio
n:Participants w
ho are willing
and able to co
mply with all
scheduled visi
ts, vaccination
plan, laborator
y tests, lifestyl
e consideratio
ns, and other s
tudy procedur
es
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN02A00
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874853
Page 120 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.b Inclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Participants who are
willing and able to c
omply with all sched
uled visits, vaccinati
on plan, laboratory t
ests, lifestyle conside
rations, and other stu
dy proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874854
Page 121 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Incl
usio
n N
umb
er:3
Crit
erio
n D
escr
iptio
n:Healthy partic
ipants who are
determined by
medical histor
y, physical exa
mination, and
clinical judgm
ent of the inve
stigator to be e
ligible for incl
usion in the st
udyInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874855
Page 122 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN03A00
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874856
Page 123 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.c Inclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Healthy participants
who are determined
by medical history, p
hysical examination,
and clinical judgmen
t of the investigator t
o be eligible for incl
usion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874857
Page 124 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Incl
usio
n N
umb
er:4
Crit
erio
n De
scri
ptio
n:Capable of giv
ing personal si
gned informed
consent, whic
h includes co
mpliance with
the requireme
nts and restrict
ions listed in t
he ICD and in
this protocol
Crit
erio
n m
et?:YESInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874858
Page 125 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN04A00
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874859
Page 126 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.d Inclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Capable of giving pe
rsonal signed inform
ed consent, which in
cludes compliance w
ith the requirements
and restrictions liste
d in the ICD and in t
his protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874860
Page 127 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Excl
usio
n N
um
ber:1
Crit
erio
n D
escr
ipti
on:Other medical
or psychiatric
condition incl.
recent (within
past year) or a
ctive suicidal i
deation/behavi
or/lab abnorm
ality that may
increase the ri
sk of study par
ticipationInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874861
Page 128 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n m
et?:NO
Crit
erio
n ID
: (F
or P
fize
r us
e on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Other medical or psy
chiatric condition inc
l. recent (within past
year) or active suicid
al ideation/behavior/lInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874862
Page 129 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
ab abnormality that
may increase the risk
of study participatio
n
2.a Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Excl
usion
Num
ber:2Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874863
Page 130 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crite
rion
Desc
ripti
on:Known infect
ion with hum
an immunode
ficiency virus
(HIV), hepati
tis C virus (H
CV), or hepat
itis B virus (
HBV)
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX02A00
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874864
Page 131 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.b Exclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Known infection wit
h human immunodef
iciency virus (HIV),
hepatitis C virus (HC
V), or hepatitis B vir
us (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874865
Page 132 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Excl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:History of sev
ere adverse re
action associat
ed with a vacc
ine and/or sev
ere allergic re
action (eg, ana
phylaxis) to a
ny component
of the study in
tervention(s)
Crit
erio
n m
et?:NOInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874866
Page 133 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX03A00
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874867
Page 134 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.c Exclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
History of severe ad
verse reaction associ
ated with a vaccine a
nd/or severe allergic
reaction (eg, anaphyl
axis) to any compon
ent of the study inter
vention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874868
Page 135 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusi
on Nu
mber:4
Criteri
on Desc
ription:Receipt of
medication
s intended
to prevent
COVID-19
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX04A00Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874869
Page 136 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.d Exclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Receipt of medicatio
ns intended to preve
nt COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) CityACV0PFEINFP6000 Martina
DavalliData Entry:
EX04A00Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874870
Page 137 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
of Buenos Aires
2.e
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Excl
usio
n Nu
mbe
r:8
Crit
erio
n De
scri
ptio
n:Immunocomp
romised indivi
duals with kn
own or suspec
ted immunode
ficiency, as de
termined by h
istory and/or l
aboratory/phy
sical examinat
ion
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874871
Page 138 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX08A00
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874872
Page 139 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.e Exclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Immunocompromise
d individuals with kn
own or suspected im
munodeficiency, as d
etermined by history
and/or laboratory/ph
ysical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874873
Page 140 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Excl
usio
n N
umb
er:10
Crit
erio
n De
scri
ptio
n:Bleeding diath
esis or conditi
on associated
with prolonge
d bleeding tha
t would, in the
opinion of the
investigator, c
ontraindicate i
ntramuscular i
njection
Crit
erio
n m
et?:NOInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874874
Page 141 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX10A00
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874875
Page 142 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.f Exclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Bleeding diathesis or
condition associated
with prolonged bleed
ing that would, in the
opinion of the investi
gator, contraindicate
intramuscular injecti
onInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874876
Page 143 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusio
n Numb
er:11
Criterio
n Descri
ption:Women w
ho are pre
gnant or b
reastfeedi
ng
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX11A00Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874877
Page 144 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.g Exclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Women who are pre
gnant or breastfeedin
gInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) CityACV0PFEINFP6000 Martina
DavalliData Entry:
EX11A00Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874878
Page 145 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
of Buenos Aires
2.h
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusi
on Num
ber:12
Criterio
n Descr
iption:Previous v
accination
with any c
oronavirus
vaccine
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX12A00Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874879
Page 146 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.h Exclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Previous vaccination
with any coronavirus
vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) CityACV0PFEINFP6000 Martina
DavalliData Entry:
EX12A00Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874880
Page 147 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
of Buenos Aires
2.i
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclu
sion
Num
ber:13
Crite
rion
Descr
iptio
n:Subjects who
receive imm
unosuppressi
ve therapy, s
uch as cytoto
xic agents or
systemic cort
icosteroids
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX13A01Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874881
Page 148 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.i Exclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Subjects who receive
immunosuppressive t
herapy, such as cytot
oxic agents or syste
mic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874882
Page 149 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Excl
usio
n N
umb
er:15
Crit
erio
n De
scri
ptio
n:Receipt of blo
od/plasma pro
ducts or immu
noglobulin, fr
om 60 days be
fore study inte
rvention admi
nistration or p
lanned receipt
throughout th
e study
Crit
erio
n m
et?:NOInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874883
Page 150 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX14A01
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874884
Page 151 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.j Exclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Receipt of blood/pla
sma products or imm
unoglobulin, from 60
days before study int
ervention administrat
ion or planned receip
t throughout the stud
yInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874885
Page 152 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX14A01Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874886
Page 153 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
2.k
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Excl
usio
n Nu
mbe
r:16
Crit
erio
n De
scrip
tion:Participation
in other studi
es involving
study interve
ntion within
28 days prior
to study entry
and/or during
study particip
ation
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874887
Page 154 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX15A01
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874888
Page 155 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.k Exclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Participation in othe
r studies involving s
tudy intervention wi
thin 28 days prior to
study entry and/or d
uring study participa
tionInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874889
Page 156 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclu
sion
Num
ber:17
Crite
rion
Descr
iption
:Previous par
ticipation in
other studies
involving st
udy interven
tion containi
ng lipid nan
oparticles
Crite
rion
met?:NOInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874890
Page 157 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX16A01
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874891
Page 158 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.l Exclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Previous participatio
n in other studies in
volving study interv
ention containing lip
id nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874892
Page 159 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exc
lusi
on
Nu
mbe
r:22
Crit
erio
n D
escr
ipti
on:Investigator si
te staff or Pfiz
er employees
directly invol
ved in the con
duct of the stu
dy, site staff o
therwise super
vised by the i
nvestigator, an
d their respect
ive family me
mbersInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874893
Page 160 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n m
et?:NO
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:EX21A01
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874894
Page 161 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.m Exclusion Number:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Investigator site staf
f or Pfizer employee
s directly involved i
n the conduct of the
study, site staff other
wise supervised by t
he investigator, and t
heir respective famil
y membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874895
Page 162 of 258
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020
16:48:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX21A01Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874896
Page 163 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-23-2020
16:49:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-23-2020
16:49:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-23-2020
16:49:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
COMPLETEDInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874897
Page 164 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date:
Date Location User Value Reason
Aug-23-2020
16:50:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/23/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-23-2020
16:50:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
115.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-23-2020
16:50:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874898
Page 165 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020
16:50:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
181.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-23-2020
16:50:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-23-2020
16:50:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35.1Initial Entry
7.a
Date Location User Value Reason
Aug-23-2020
16:50:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Record Id
entifier::1
Temperatu
re:37.2Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874899
Page 166 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-23-2020
16:50:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-23-2020
16:50:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
37.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-23-2020
16:50:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
CInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874900
Page 167 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
7.a Temperature Location:
Date Location User Value Reason
Aug-23-2020
16:50:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
ORAL CAVITYInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874901
Page 168 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-23-2020
16:50:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/23/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-23-2020
16:50:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
237590Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874902
Page 169 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-23-2020
16:50:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-23-2020
16:50:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020
17:59:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-24-2020
02:43:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0874903
Page 170 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
are entered.
Please review
and correct as
appropriate.
Aug-23-2020
16:50:26
(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.
Aug-23-2020
16:50:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection
:
Aug/23/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020
17:59:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample I
D:BNTNF
DInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874904
Page 171 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-25-2020
17:59:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BNTNFDInitial Entry
5.b
Date Location User Value Reason
Aug-25-2020
17:59:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample I
D:BNTNF
FInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-25-2020
17:59:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BNTNFFInitial Entry
5.c
Date Location User Value Reason
Oct-29-2020
15:08:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP24C4Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874905
Page 172 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.c Sample ID
Date Location User Value Reason
Oct-29-2020
15:08:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BP24C4Initial Entry
5.d
Date Location User Value Reason
Oct-29-2020
15:08:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP24C5Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-29-2020
15:08:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BP24C5Initial Entry
5.e
Date Location User Value Reason
Oct-29-2020
15:08:46
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
Sample ID: BP24C6Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874906
Page 173 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
of Buenos Aires
5.e Sample ID
Date Location User Value Reason
Oct-29-2020
15:08:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BP24C6Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874907
Page 174 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-23-2020
16:50:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-23-2020
16:50:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020
15:49:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-24-2020
02:43:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0874908
Page 175 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
are entered.
Please review
and correct as
appropriate.
Aug-23-2020
16:50:36
(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.
Aug-23-2020
16:50:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection
:
Aug/23/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020
15:49:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID
:BP26G
4Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874909
Page 176 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-24-2020
15:49:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BP26G4Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874910
Page 177 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-23-2020
16:50:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-23-2020
16:50:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-23-2020
16:50:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-23-2020 ACV0PFEINFP6000 Martina Data Entry: Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874911
Page 178 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
16:50:55
(UTC-03:00) City
of Buenos AiresDavalli Aug/23/2020 15:35
5. Anatomical Location:
Date Location User Value Reason
Aug-23-2020
16:50:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-23-2020
16:50:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-23-2020
16:50:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874912
Page 179 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020
16:50:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-23-2020
16:50:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874913
Page 180 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-23-2020
16:51:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874914
Page 181 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-16-2020
10:47:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874915
Page 182 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020
10:47:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-16-2020
10:47:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.7
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-16-2020
10:47:20
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874916
Page 183 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
of Buenos Aires
2.a Temperature:
Date Location User Value Reason
Sep-16-2020
10:47:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-16-2020
10:47:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-16-2020
10:47:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874917
Page 184 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020
10:07:16
(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
10:07:16
(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
10:07:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-16-2020
10:07:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874918
Page 185 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
are entered.
Please review
and correct as
appropriate.
Sep-16-2020
10:07:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020
10:07:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID
:BP1RD
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020
10:07:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BP1RDXInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874919
Page 186 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-16-2020
10:47:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020
10:47:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020
10:47:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-16-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874920
Page 187 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
10:47:49
(UTC-03:00) City
of Buenos AiresSep/15/2020 17:05
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020
10:47:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-16-2020
10:47:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-16-2020
10:47:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874921
Page 188 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Sep-16-2020
10:47:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-16-2020
10:47:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874922
Page 189 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020
15:47:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0874923
Page 190 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020
15:47:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020
15:47:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020
18:10:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
15:47:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874924
Page 191 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
are entered.
Please review
and correct as
appropriate.
Oct-19-2020
15:47:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020
18:10:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BPWDJ
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020
18:10:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPWDJDInitial Entry
5.b
Date Location User Value Reason
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0874925
Page 192 of 258
***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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Oct-19-2020
18:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BLBH4
4Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020
18:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BLBH44Initial Entry
5.c
Date Location User Value Reason
Oct-19-2020
19:03:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample I
D:BLBH2
LInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020
19:03:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BLBH2LInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874926
Page 193 of 258
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-20-2021
17:31:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/20/2021Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0874927
Page 194 of 258
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-20-2021
17:32:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-20-2021
17:32:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-22-2021
11:45:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-20-2021
17:32:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874928
Page 195 of 258
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
are entered.
Please review
and correct as
appropriate.
Mar-20-2021
17:32:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/20/2021Initial Entry
5.a
Date Location User Value Reason
Mar-22-2021
11:45:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BS1V6
GInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-22-2021
11:45:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BS1V6GInitial Entry
5.b
Date Location User Value Reason
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0874929
Page 196 of 258
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Mar-22-2021
12:31:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BR1YS
2Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-22-2021
12:31:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BR1YS2Initial Entry
5.c
Date Location User Value Reason
Mar-22-2021
12:44:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BS1V6
7Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-22-2021
12:44:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BS1V67Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0874930
Page 197 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-13-2020
14:55:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Nov-13-2020
14:44:25
(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.
Nov-13-2020
14:44:25
(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
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874931
Page 198 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Swab Self and
Nasal Swab
are missing.
Please review
and update as
appropriate.
Nov-13-2020
14:44:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Nov/12/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-13-2020
14:44:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874932
Page 199 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Nov/12/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Nov/11/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Nov-20-2020
04:20:41
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Closed MARKED THE
SYMPTOMS BY
ERROR
Nov-19-2020
18:20:39
(UTC-03:00)ACV0PFEINFP6000 Query 1: Answe
redVOLUNTEER IS
ASYMPTOMATIC
AND MARKED
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874933
Page 200 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
City of Buenos
AiresTHE SYMPTOMS
BY ERROR, since
he was referring to
those of November
11. Thank you.
Nov-19-2020
00:23:15
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Opene
dIllness eDiary:
Subject has
reported as Yes in
the COVID Illness
Diary for
15NOV2020,
however, the
symptoms ongoing
is reported as No
with 11NOV2020,
please review the
resolved date and
confirm if
15NOV2020 was
erroneous entry or
please clarify
Nov-13-2020
14:56:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NO
Date of Last S
ymptom Resol
ved:
Nov/11/2020Transcription Error
Nov-13-2020
14:54:16ACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874934
Page 201 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
(UTC-03:00)
City of Buenos
Aires
4.a
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptoms: FEV
ER
Symptom Pr
esent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
4.b
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874935
Page 202 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sympt
oms:NEW OR I
NCREASE
D COUGH
Sympt
om Pr
esent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Nov-13-2020 ACV0PFEINFP6000 Martina Data Entry: Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874936
Page 203 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
14:54:16
(UTC-03:00) City
of Buenos AiresDavalli Sym
ptom
s:NEW OR IN
CREASED S
HORTNESS
OF BREATH
Sym
ptom
Prese
nt:NO
4.c Symptoms:
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEW OR INCREAS
ED SHORTNESS O
F BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Nov-13-2020
14:54:16ACV0PFEINFP6000 Martina
DavalliData Entry:
Symptoms: CHILInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874937
Page 204 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
(UTC-03:00) City
of Buenos AiresLS
Symptom P
resent:NO
4.d Symptoms:
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symp
toms:NEW OR I
NCREASE
D MUSCLE
PAINInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874938
Page 205 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Symp
tom P
resent
:NO
4.e Symptoms:
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEW OR INCREAS
ED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELLInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874939
Page 206 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Sympt
om Pr
esent:NO
4.f Symptoms:
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEW LOSS OF TA
STE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symp
toms:NEW OR I
NCREASE
D SORE TH
ROATInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874940
Page 207 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Symp
tom P
resent
:NO
4.g Symptoms:
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEW OR INCREAS
ED SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptoms
:DIARR
HEA
Symptom
Present:YESInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874941
Page 208 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
4.h Symptoms:
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptoms
:VOMI
TING
Symptom
Present:NOInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874942
Page 209 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
4.i Symptoms:
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-13-2020
14:54:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Nov-13-2020
14:54:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptoms -
Other:asthe
niaInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Nov-13-2020
14:54:27
(UTC-03:00) CityACV0PFEINFP6000 Martina
DavalliData Entry:
astheniaInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874943
Page 210 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
of Buenos Aires
5.b
Date Location User Value Reason
Nov-13-2020
14:54:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptom
s - Other:abdomi
nal painInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Nov-13-2020
14:54:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
abdominal painInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874944
Page 211 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Date Location User Value Reason
Nov-13-2020
14:55:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliForm Created
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874945
Page 212 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-13-2020
14:55:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Nov/12/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-13-2020
14:55:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
SWABBED MATER
IALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-13-2020
14:55:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-13-2020 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874946
Page 213 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
14:55:10
(UTC-03:00) City
of Buenos Aires(autocalc) SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2
5. Device Type:
Date Location User Value Reason
Nov-13-2020
14:55:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGN
OSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-13-2020
14:55:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
ATILA BIOSYSTE
MS IAMP COVID-1
9 DETECTION KITInitial Entry
7. Test Result:
Date Location User Value Reason
Nov-13-2020
14:55:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEGATIVEInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874947
Page 214 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020
14:55:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020
14:55:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020
14:55:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874948
Page 215 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Nov-13-2020
14:55:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
sample collected by t
eam physicianInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874949
Page 216 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020
14:55:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020
14:55:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020
17:36:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-13-2020
16:31:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0874950
Page 217 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
are entered.
Please review
and correct as
appropriate.
Nov-13-2020
14:55:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-13-2020
14:55:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection
:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020
17:36:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID
:BPT85
8Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874951
Page 218 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Nov-13-2020
17:36:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BPT858Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874952
Page 219 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.a
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Type of Prac
titioner:SPEC
IALI
ST
Occurrence
of Visits or
Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874953
Page 220 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.b
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Type of Pr
actitioner:EMER
GENC
Y ROO
M
Occurrenc
e of Visits
or Contact
s:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EMERGENCY RO
OMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
1.c
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874954
Page 221 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Type of P
ractition
er:PRIMAR
Y CARE
PHYSIC
IAN
Occurre
nce of Vi
sits or Co
ntacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
PRIMARY CARE P
HYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874955
Page 222 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Type of Pra
ctitioner:URGE
NT C
ARE
Occurrence
of Visits or
Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) CityACV0PFEINFP6000 Martina
DavalliData Entry:
Type of P
ractitionTELEPH
ONE COInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874956
Page 223 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
of Buenos Aires er: NSULTA
TION
Occurre
nce of Vi
sits or Co
ntacts:NO
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
TELEPHONE CON
SULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Type of Practi
tioner:OT
HE
RInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874957
Page 224 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Occurrence of
Visits or Cont
acts:NO
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Nov-13-2020
14:57:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874958
Page 225 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/12/2020Form: 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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Nov-13-2020
14:56:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-
19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Nov-13-2020
14:56:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-13-2020
14:56:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
2Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0874959
Page 226 of 258
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/15/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
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: 12313496 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-15-2020
14:36:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/15/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-15-2020
14:36:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae2e78\Final\Final On: 01-Apr-2021 03:14 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0874960
Page 227 of 258
***Confidential***
Header Text: C4591001
Visit: P
…[truncated]