125742 S1 M5 CRF c4591001 1231 12311635

Document text

Page 1 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862721
Page 2 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/16/2020
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862722
Page 3 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12311635]
2.Birth Date: /1978
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862723
Page 4 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/16/2020
2.Erroneous Visit
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862724
Page 5 of 228
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862725
Page 6 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862726
Page 7 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862727
Page 8 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862728
Page 9 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862729
Page 10 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862730
Page 11 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862731
Page 12 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862732
Page 13 of 228
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/16/2020
2.Weight: [97.2]
3.Unit: kg
4.Height: [168.0]
5.Unit: cm
6.Body Mass Index: [34.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862733
Page 14 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/16/2020
2.Randomization Number: [52037]
3.Randomization Group: [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862734
Page 15 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/16/2020
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 [BP151X]
5.bSample ID [BP151Y]
5.cSample ID [BP151Z]
5.dSample ID [BPHMKN]
5.eSample ID [BPHMKP]
5.fSample ID [BPHMKR]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862735
Page 16 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/16/2020
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 [BP151H]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862736
Page 17 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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/16/2020 16:45
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
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862737
Page 18 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862738
Page 19 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862739
Page 20 of 228
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862740
Page 21 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP27BD]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862741
Page 22 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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/4/2020 13:40
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
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862742
Page 23 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862743
Page 24 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/9/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BJ51D3]
5.bSample ID [BJ51CW]
5.cSample ID [BKPDW5]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862744
Page 25 of 228
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862745
Page 26 of 228
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/2/2021
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 [BR23PL]
5.bSample ID [BNTZ6X]
5.cSample ID [BNTZ77]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862746
Page 27 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862747
Page 28 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862748
Page 29 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862749
Page 30 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862750
Page 31 of 228
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862751
Page 32 of 228
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862752
Page 33 of 228
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862753
Page 34 of 228
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: 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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862754
Page 35 of 228
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862755
Page 36 of 228
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862756
Page 37 of 228
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862757
Page 38 of 228
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862758
Page 39 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862759
Page 40 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862760
Page 41 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862761
Page 42 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862762
Page 43 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862763
Page 44 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862764
Page 45 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862765
Page 46 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862766
Page 47 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862767
Page 48 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862768
Page 49 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862769
Page 50 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862770
Page 51 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862771
Page 52 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862772
Page 53 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862773
Page 54 of 228
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862774
Page 55 of 228
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862775
Page 56 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Insta
nce
 1.ADVERS
E EVENT
 1  Molar pregnancy in
partner Jan/UNK/20
21 UNK:UN
K NO
End Date Time:
Jan/UNK/2021
UNK:UNK
 Repeating
Pages
 2.ADVERS
E EVENT
 2  Drug exposed pregn
ancy ( female partne
r ) Nov/20/2020
18:00 NO
End Date Time:
Jan/UNK/2021
UNK:UNK
 Repeating
Pages
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862776
Page 57 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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)[Molar pregnancy in partner]
4.Start Date Time: Jan/UNK/2021 UNK:UNK Comments
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/UNK/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862777
Page 58 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital
anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong
hospitalization?
NO
Did this serious event result in persistent or
significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862778
Page 59 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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:
[it is unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021050837]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862779
Page 60 of 228
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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)[Drug exposed pregnancy ( female partner )]
4.Start Date Time: Nov/20/2020 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/UNK/2021 UNK:UNK
6.Toxicity Grade: Not Applicable Comments
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862780
Page 61 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862781
Page 62 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862782
Page 63 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862783
Page 64 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862784
Page 65 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862785
Page 66 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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: //
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862786
Page 67 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862787
Page 68 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862788
Page 69 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862789
Page 70 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862790
Page 71 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862791
Page 72 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862792
Page 73 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862793
Page 74 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862794
Page 75 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862795
Page 76 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862796
Page 77 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862797
Page 78 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/9/2020
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862798
Page 79 of 228
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862799
Page 80 of 228
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Yanina
Rivera Approved Mar-11-2021 17:36:40 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, YaninaRivera, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862800
Page 81 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormAug-16-2020 18:07:38
(UTC-03:00) City of Buenos AiresNot Applicable
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862801
Page 82 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
4Feb-11-2021 17:46:35 (UTC-03:00)
City of Buenos AiresThe start date of the event Molar
Pregnancy unk is clarified- Jan- 2021
18:00 hs. SAE unk end date -Jan
-2021. The system does not allow to
indicate the UNK option for this
purpose if you put "1"
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862802
Page 83 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
6Feb-11-2021 17:50:32 (UTC-03:00)
City of Buenos AiresIt is clarified that the degree of
intensity is not applicable.
Not Applicable
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862803
Page 84 of 228
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Yanina
Rivera Approved Mar-11-2021 17:36:40 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, YaninaRivera, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-05-2021 14:05:00 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-31-2021 14:59:47 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862804
Page 85 of 228
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-24-2021 21:16:23 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-20-2021 21:15:19 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862805
Page 86 of 228
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-13-2021 12:20:45 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-22-2020 14:59:12 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862806
Page 87 of 228
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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.
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862807
Page 88 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-16-2020
18:06:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-16-2020
18:06:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862808
Page 89 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-16-2020
18:06:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Con
sent Obtained
Aug/16/2020Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862809
Page 90 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-16-2020
16:40:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12311635Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-16-2020
16:40:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1978Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-16-2020
18:06:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-16-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862810
Page 91 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
18:06:40
(UTC-03:00) City
of Buenos AiresHISPANIC OR LA
TINO(A) OR OF S
PANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-16-2020
18:06:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862811
Page 92 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-16-2020
18:06:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/16/2020Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862812
Page 93 of 228
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber
:1
Cri
teri
on
Des
crip
tion
:Male or fema
le participant
s between th
e ages of 18
and 55 years,
inclusive, 65
and 85 years,
inclusive, or
18 and 85 ye
ars, inclusive
, at randomiz
ation (depen
dent upon stu
dy stage)
Cri
teri
on
met
?:YESInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862813
Page 94 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Cri
teri
on I
D: (
For
Pfiz
er u
se o
nly)
:IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female par
ticipants between t
he ages of 18 and 5
5 years, inclusive,
65 and 85 years, in
clusive, or 18 and
85 years, inclusive,
at randomization (Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862814
Page 95 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
dependent upon st
udy stage)
1.a Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:2Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862815
Page 96 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n D
escr
ipti
on:Participants
who are willi
ng and able t
o comply wit
h all schedul
ed visits, vac
cination plan
, laboratory t
ests, lifestyle
consideratio
ns, and other
study proced
ures
Crit
erio
n m
et?:YES
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:IN02A00
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862816
Page 97 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Inclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who ar
e willing and able t
o comply with all s
cheduled visits, va
ccination plan, lab
oratory tests, lifest
yle considerations,
and other study pro
ceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862817
Page 98 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:3
Crit
erio
n D
escr
ipti
on:Healthy parti
cipants who
are determin
ed by medic
al history, ph
ysical exami
nation, and c
linical judgm
ent of the inv
estigator to b
e eligible for
inclusion in t
he studyInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862818
Page 99 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n m
et?:YES
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:IN03A00
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862819
Page 100 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Inclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participant
s who are determin
ed by medical hist
ory, physical exam
ination, and clinica
l judgment of the i
nvestigator to be el
igible for inclusion
in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862820
Page 101 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:4
Crit
erio
n D
escr
ipti
on:Capable of g
iving person
al signed inf
ormed conse
nt, which inc
ludes compli
ance with th
e requiremen
ts and restric
tions listed i
n the ICD an
d in this prot
ocolInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862821
Page 102 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n m
et?:YES
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:IN04A00
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862822
Page 103 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Inclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving
personal signed inf
ormed consent, wh
ich includes compl
iance with the requ
irements and restri
ctions listed in the
ICD and in this pro
tocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862823
Page 104 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exc
lusi
on
Nu
mb
er:1Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862824
Page 105 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n D
escr
ipti
on:Other medic
al or psychia
tric conditio
n incl. recent
(within past
year) or activ
e suicidal ide
ation/behavi
or/lab abnor
mality that m
ay increase t
he risk of stu
dy participati
on
Crit
erio
n m
et?:NO
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:EX01A00
2.a Exclusion Number:
Date Location User Value Reason
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862825
Page 106 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or p
sychiatric conditio
n incl. recent (with
in past year) or acti
ve suicidal ideatio
n/behavior/lab abn
ormality that may i
ncrease the risk of
study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862826
Page 107 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:2
Crit
erio
n De
scrip
tion:Known infe
ction with h
uman immu
nodeficienc
y virus (HI
V), hepatitis
C virus (HC
V), or hepat
itis B virus (
HBV)
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862827
Page 108 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX02A00
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862828
Page 109 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.b Exclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection w
ith human immuno
deficiency virus (H
IV), hepatitis C vir
us (HCV), or hepat
itis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862829
Page 110 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exc
lusi
on
Nu
mbe
r:3
Crit
erio
n D
escr
ipti
on:History of se
vere adverse
reaction asso
ciated with a
vaccine and/
or severe all
ergic reactio
n (eg, anaph
ylaxis) to an
y component
of the study i
ntervention(
s)Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862830
Page 111 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n m
et?:NO
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:EX03A00
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862831
Page 112 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Exclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe a
dverse reaction ass
ociated with a vacc
ine and/or severe a
llergic reaction (eg
, anaphylaxis) to a
ny component of t
he study interventi
on(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862832
Page 113 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:4
Criteri
on Des
criptio
n:Receipt o
f medicati
ons inten
ded to pre
vent COV
ID-19
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX04A00Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862833
Page 114 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.d Exclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medicat
ions intended to pr
event COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862834
Page 115 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
2.e
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
um
ber:8
Crit
erio
n D
escr
ipti
on:Immunocom
promised in
dividuals wit
h known or s
uspected im
munodeficie
ncy, as deter
mined by his
tory and/or l
aboratory/ph
ysical exami
nation
Crit
erio
n m
et?:NOInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862835
Page 116 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (F
or P
fize
r us
e on
ly):EX08A00
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862836
Page 117 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e Exclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromi
sed individuals wit
h known or suspect
ed immunodeficien
cy, as determined b
y history and/or la
boratory/physical e
xaminationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862837
Page 118 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
um
ber:10
Crit
erio
n D
escr
ipti
on:Bleeding dia
thesis or con
dition associ
ated with pr
olonged blee
ding that wo
uld, in the o
pinion of the
investigator,
contraindicat
e intramuscu
lar injectionInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862838
Page 119 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n m
et?:NO
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:EX10A00
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862839
Page 120 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.f Exclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis
or condition associ
ated with prolonge
d bleeding that wo
uld, in the opinion
of the investigator,
contraindicate intra
muscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862840
Page 121 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:11
Criteri
on Desc
ription:Women
who are
pregnant
or breast
feeding
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX11A0
0Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862841
Page 122 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.g Exclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are pr
egnant or breastfee
dingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862842
Page 123 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
2.h
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:12
Criteri
on Des
criptio
n:Previous
vaccinati
on with a
ny coron
avirus va
ccine
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX12A0
0Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862843
Page 124 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.h Exclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccinati
on with any corona
virus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862844
Page 125 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
2.i
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:13
Crite
rion
Desc
ripti
on:Subjects wh
o receive i
mmunosup
pressive the
rapy, such a
s cytotoxic
agents or sy
stemic corti
costeroids
Crite
rion
met?
:NOInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862845
Page 126 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crite
rion
ID: (
For
Pfize
r use
only)
:EX13A01
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862846
Page 127 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.i Exclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who recei
ve immunosuppres
sive therapy, such
as cytotoxic agents
or systemic cortico
steroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862847
Page 128 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
um
ber:15
Crit
erio
n D
escr
ipti
on:Receipt of bl
ood/plasma
products or i
mmunoglob
ulin, from 6
0 days befor
e study inter
vention adm
inistration or
planned rece
ipt througho
ut the study
Crit
erio
n m
et?:NOInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862848
Page 129 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:EX14A01
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862849
Page 130 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.j Exclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/pl
asma products or i
mmunoglobulin, fr
om 60 days before
study intervention
administration or p
lanned receipt thro
ughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862850
Page 131 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862851
Page 132 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.k
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:16
Crit
erio
n De
scri
ptio
n:Participatio
n in other st
udies involv
ing study in
tervention
within 28 d
ays prior to
study entry
and/or durin
g study part
icipation
Crit
erio
n m
et?:NOInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862852
Page 133 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX15A01
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862853
Page 134 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Exclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participation in ot
her studies involvi
ng study interventi
on within 28 days
prior to study entr
y and/or during stu
dy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862854
Page 135 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:17
Crite
rion
Desc
ripti
on:Previous p
articipation
in other stu
dies involv
ing study i
ntervention
containing
lipid nanop
articles
Crite
rion
met?
:NOInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862855
Page 136 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crite
rion
ID: (
For
Pfize
r use
only)
:EX16A01
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862856
Page 137 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.l Exclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Previous participat
ion in other studie
s involving study i
ntervention contai
ning lipid nanopar
ticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862857
Page 138 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exc
lusi
on
Nu
mb
er:22Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862858
Page 139 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Cri
teri
on
Des
crip
tion
:Investigator
site staff or
Pfizer emplo
yees directly
involved in t
he conduct o
f the study, s
ite staff othe
rwise superv
ised by the i
nvestigator,
and their res
pective fami
ly members
Cri
teri
on
met
?:NO
Cri
teri
on I
D: (
For
Pfiz
er u
se o
nly)
:EX21A01
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862859
Page 140 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Exclusion Number:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Investigator site st
aff or Pfizer emplo
yees directly invol
ved in the conduct
of the study, site st
aff otherwise supe
rvised by the inves
tigator, and their r
espective family
membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862860
Page 141 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
City of Buenos
Aires
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020
18:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862861
Page 142 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-16-2020
18:07:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-16-2020
18:07:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-16-2020
18:07:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862862
Page 143 of 228
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Aug-16-2020
18:08:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-16-2020
18:08:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
97.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-16-2020
18:08:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862863
Page 144 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
18:08:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
168.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-16-2020
18:08:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-16-2020
18:08:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
34.4Initial Entry
7.a
Date Location User Value Reason
Aug-16-2020
18:08:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record I
dentifier:
:1
Temperat
ure:36.1Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862864
Page 145 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Temperat
ure Unit:C
Temperat
ure Locat
ion::ORAL
CAVI
TY
7.a Record Identifier:
Date Location User Value Reason
Aug-16-2020
18:08:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-16-2020
18:08:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 
)Data Entry:
36.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-16-2020
18:08:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862865
Page 146 of 228
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
7.a Temperature Location:
Date Location User Value Reason
Aug-16-2020
18:08:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862866
Page 147 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-16-2020
18:08:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-16-2020
18:08:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
52037Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862867
Page 148 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-16-2020
18:08:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-16-2020
18:08:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020
08:47:12
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-16-2020
18:08:52
(UTC-03:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862868
Page 149 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
City of Buenos
Airesno barcodes
are entered.
Please review
and correct as
appropriate.
Aug-16-2020
18:08:52
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Aug/16/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020
08:47:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP151
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-17-2020
08:47:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP151XInitial Entry
5.b
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862869
Page 150 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-17-2020
08:47:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP151
YInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-17-2020
08:47:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP151YInitial Entry
5.c
Date Location User Value Reason
Aug-17-2020
08:47:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP151ZInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-17-2020
08:47:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP151ZInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862870
Page 151 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.d
Date Location User Value Reason
Aug-18-2020
14:08:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPHMK
NInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-18-2020
14:08:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPHMKNInitial Entry
5.e
Date Location User Value Reason
Aug-18-2020
14:08:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPHMK
PInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862871
Page 152 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.e Sample ID
Date Location User Value Reason
Aug-18-2020
14:08:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPHMKPInitial Entry
5.f
Date Location User Value Reason
Aug-18-2020
14:09:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPHMK
RInitial Entry
5.f Sample ID
Date Location User Value Reason
Aug-18-2020
14:09:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPHMKRInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862872
Page 153 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-16-2020
18:08:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-16-2020
18:08:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020
10:32:44
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-16-2020
18:08:58
(UTC-03:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862873
Page 154 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
City of Buenos
Airesno barcodes
are entered.
Please review
and correct as
appropriate.
Aug-16-2020
18:08:58
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Aug/16/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020
10:32:44
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BP151
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-17-2020
10:32:44
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP151HInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862874
Page 155 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-16-2020
18:09:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-16-2020
18:09:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-16-2020
18:09:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-16-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862875
Page 156 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
18:09:20
(UTC-03:00) City
of Buenos AiresAug/16/2020 16:4
5
5. Anatomical Location:
Date Location User Value Reason
Aug-16-2020
18:09:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-16-2020
18:09:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-16-2020
18:09:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862876
Page 157 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
18:09:20
(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-16-2020
18:09:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862877
Page 158 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-16-2020
18:09:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTE
D FOR THIS SUB
JECTInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862878
Page 159 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-04-2020
15:37:31
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862879
Page 160 of 228
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020
15:37:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2.a
Date Location User Value Reason
Sep-04-2020
15:37:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record I
dentifier:
:1
Temperat
ure:36.1
Temperat
ure Unit:C
Temperat
ure Locat
ion::ORAL
CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0862880
Page 161 of 228
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-04-2020
15:37:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-04-2020
15:37:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
36.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-04-2020
15:37:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-04-2020
15:37:54
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862881
Page 162 of 228
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aires
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862882
Page 163 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020
15:38:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
15:38:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020
09:28:28
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-04-2020
17:28:59
(UTC-03:00)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862883
Page 164 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
City of Buenos
Airesno barcodes
are entered.
Please review
and correct as
appropriate.
Sep-04-2020
15:38:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-04-2020
15:38:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-07-2020
09:28:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BP27B
DInitial Entry
5.a Sample ID
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862884
Page 165 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Sep-07-2020
09:28:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP27BDInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862885
Page 166 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-04-2020
15:38:24
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020
15:38:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020
15:38:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862886
Page 167 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-04-2020
15:38:24
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020 13:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020
15:38:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-04-2020
15:38:24
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020
15:38:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862887
Page 168 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-04-2020
15:38:24
(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-04-2020
15:38:24
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862888
Page 169 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-09-2020
09:48:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862889
Page 170 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-09-2020
09:48:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-09-2020
09:48:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020
12:40:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-09-2020
09:48:28
(UTC-03:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862890
Page 171 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
City of Buenos
Airesno barcodes
are entered.
Please review
and correct as
appropriate.
Oct-09-2020
09:48:28
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Oct/9/2020Initial Entry
5.a
Date Location User Value Reason
Oct-09-2020
12:40:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BJ51D
3Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-09-2020
12:40:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BJ51D3Initial Entry
5.b
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862891
Page 172 of 228
***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: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Oct-09-2020
13:13:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BJ51C
WInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-09-2020
13:13:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BJ51CWInitial Entry
5.c
Date Location User Value Reason
Oct-09-2020
13:37:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample I
D:BKPDW
5Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-09-2020
13:37:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BKPDW5Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862892
Page 173 of 228
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021
15:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/2/2021Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862893
Page 174 of 228
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-02-2021
15:20:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-02-2021
15:20:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-03-2021
09:38:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-03-2021
08:28:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862894
Page 175 of 228
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
are entered.
Please review
and correct as
appropriate.
Mar-02-2021
15:20:49
(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.
Mar-02-2021
15:20:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/2/2021Initial Entry
5.a
Date Location User Value Reason
Mar-03-2021
09:38:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BR23P
LInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862895
Page 176 of 228
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Mar-03-2021
09:38:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR23PLInitial Entry
5.b
Date Location User Value Reason
Mar-03-2021
10:48:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BNTZ6
XInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-03-2021
10:48:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTZ6XInitial Entry
5.c
Date Location User Value Reason
Mar-03-2021
10:58:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BNTZ7
7Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862896
Page 177 of 228
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.c Sample ID
Date Location User Value Reason
Mar-03-2021
10:58:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTZ77Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862897
Page 178 of 228
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-09-2020
11:49:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020
11:49:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020
11:49:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862898
Page 179 of 228
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-13-2021
12:20:45
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Jan/12/2021Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862899
Page 180 of 228
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-13-2021
12:21:12
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Delete
dClose Auto
Query
Jan-13-2021
12:20:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candid
ateThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-13-2021
12:20:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participant is wi
lling to return fo
r Vaccination 3
Participant is:
eligible and
NOT confirmInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862900
Page 181 of 228
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
ed to have re
ceived only p
lacebo at Vac
cination 1/2
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862901
Page 182 of 228
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Jan-20-2021
17:08:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862902
Page 183 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Feb-05-2021
14:05:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862903
Page 184 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Jan-20-2021
17:08:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-20-2021
17:08:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-02-2021
12:37:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 5: Cl
osedResponse satisfies
query
Feb-26-2021
12:34:08
(UTC-03:00)ACV0PFEINFP6000  Query 5: An
sweredAt the moment this
information is not
available.
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862904
Page 185 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
City of Buenos
Aires
Feb-25-2021
13:24:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 5: Op
enedClinical If possible,
does subject report
female partner's age;
please submit if
reported
Feb-16-2021
01:21:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Cl
osedResponse satisfies
query
Feb-12-2021
10:43:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: An
sweredNew Information
Feb-12-2021
10:43:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry
:
Molar pregn
ancy in part
nerNew Information
Feb-11-2021
18:27:36
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Re
issued:Open
edClinical Thank you
for the dates. On the
term, please add 'in
Partner' to event of
Molar Pregnancy,
updating both AE
CRF and SAE event
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862905
Page 186 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
terms
Feb-11-2021
17:43:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: An
sweredThe start date of the
event Molar
Pregnancy unk is
clarified- Jan- 2021
18:00 hs. SAE unk
end date -Jan -2021.
Feb-11-2021
16:52:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Op
enedClinical As adverse
pregnancy outcome
'Molar Pregnancy'
also occurred in
subject's partner,
please add 'in
Partner' to the event
term on both AE
CRF and SAE report
(#2021050837)
Feb-10-2021
10:31:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Cl
osedResponse satisfies
query
Jan-28-2021
10:45:31
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Marjorie
BuonannoQuery 1: Cl
osedResponse satisfies
query
Jan-28-2021
01:48:39ACV0PFEINFP6000  Santiago
CorradettiQuery 3: An
sweredData was vaguely
reported by the
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862906
Page 187 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00)
City of Buenos
Airessubject. Given that
subject's wife still
didn't sign an
information
disclosure consent,
we cannot provide
the requested
information yet.
Subject cancelled an
unscheduled visit
appointed for
22-JAN. We'll
update data ASAP.
Jan-28-2021
01:48:28
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Santiago
CorradettiQuery 1: An
sweredData was vaguely
reported by the
subject. Given that
subject's wife still
didn't sign an
information
disclosure consent,
we cannot provide
the requested
information yet.
Subject cancelled an
unscheduled visit
appointed for
22-JAN. We'll
update data ASAP.
Jan-27-2021
15:47:17
(UTC-03:00)ACV0PFEINFP6000  Query 3: Op
enedClinical - Please
report the
(non-serious) event
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862907
Page 188 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
City of Buenos
Airesof Maternal
Exposure during
Pregnancy on the
AE CRF, and as a
pregnancy event to
Safety.
Jan-27-2021
15:45:10
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Cl
osedsocial history for
subject submitted
Jan-22-2021
16:28:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Op
enedClinical - please
submit to SAE the
social history
(smoke/drink/illicit
drugs) for the
subject; also partner
if available
Jan-21-2021
20:05:51
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Marjorie
BuonannoQuery 1: Op
enedGPD Clin: Does
maternal partner
have prior history of
spontaneous
abortion or prior
molar pregnancy?
What was the
treatment/procedure?
Was histopathology
obtained? Report all
details on EDP
report and submit to
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862908
Page 189 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Pfizer Safety.
Jan-20-2021
17:08:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry
:
Molar Pregn
ancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-26-2021
11:10:28
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Jan/UNK/2021 U
NK:UNKTranscription
Error
Feb-22-2021
18:09:30
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Closed Response
satisfies query
Feb-18-2021
16:51:33
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Answere
dThe start date is
unk- Jan- 2021
18:00 pm. SAE
end date
unk-Jan-2021.
The system
does not allow
the UNK option
to be indicated,
so it is set to
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862909
Page 190 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
"1". The same
was indicated as
a comment on
02/11
Feb-16-2021
01:21:26
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Reissued
:OpenedClinical Event
start date is
01Jan21;
however, PG
safety event
start date is
??Jan21. Please
review,
harmonize
reporting and
update where
appropriate
Feb-12-2021
10:47:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Answere
dSAE safety was
sent. Thank
you.
Feb-11-2021
18:26:15
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Reissued
:OpenedClinical Thank
you for further
clarifying SAE
Molar PG start
and stop dates;
please submit a
SAE
(#2021050837)
safety f/u to
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862910
Page 191 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
report these new
dates
Feb-11-2021
17:44:24
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Answere
dThe start date of
the event Molar
Pregnancy unk
is clarified- Jan-
2021 18:00 hs.
SAE unk end
date -Jan -2021.
Feb-11-2021
17:44:24
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Jan/1/2021 18:00The start date of
the event Molar
Pregnancy unk
is clarified- Jan-
2021 18:00 hs.
SAE unk end
date -Jan -2021.
Feb-10-2021
10:35:06
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Opened Clinical Start
date is
20Nov20;
however, start
date for partner
pregnancy is
20Nov20
(which does not
start molar, but
with fetus).
Please consider
start date of
UNK/Jan/2021,
as molar PG
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862911
Page 192 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
was detected &
terminated in
UNK/Jan/2021
Jan-27-2021
15:45:53
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Closed moving query to
PG event report
Jan-22-2021
16:31:43
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Opened Clinical For
start date of this
PG, conception
date by
ultrasound
measurement of
the fetus in first
trimester is the
most accurate
method; in the
absence of US,
1st day of LMP
should be used.
If only month
can be
estimated,
report as
xxMMM2020
Jan-22-2021
16:28:59
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Query 1: Closed rewording
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862912
Page 193 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aires
Jan-22-2021
16:24:36
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened Clinical For
start date of this
PG, conception
date by
ultrasound
measurement of
the fetus during
the first
trimester is the
most accurate
method; in the
absence of US,
the 1st day of
the last
menstrual
period (LMP)
should be used
to estimate
conception.
Jan-20-2021
17:08:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Nov/20/2020 18:0
0Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-11-2021 ACV0PFEINFP6000  Query 2: Closed Response
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862913
Page 194 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
18:26:36
(UTC-03:00)
City of Buenos
Airessatisfies query
Feb-11-2021
17:44:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Answer
edThe start date
of the event
Molar
Pregnancy unk
is clarified- Jan-
2021 18:00 hs.
SAE unk end
date -Jan -2021.
Feb-11-2021
17:44:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/UNK/202
1 UNK:UNKThe start date
of the event
Molar
Pregnancy unk
is clarified- Jan-
2021 18:00 hs.
SAE unk end
date -Jan -2021.
Feb-10-2021
10:30:08
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Reissue
d:OpenedCLINICAL -
End date for
partner
pregnancy is
UNK/UNK
/2021; since
original SAE
report was on
20Jan21, the
End date for
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862914
Page 195 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
both partner PG
and molar
pregnancy was
UNK/Jan/2021.
Please update
on AE and SAE
report.
Jan-28-2021
01:50:53
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Santiago
CorradettiQuery 2: Answer
edThis is just the
diagnosis date
vaguely
referred by the
subject.
Subject's wife
still didn't sign
an information
disclosure
consent, so we
cannot provide
the requested
information yet.
Subject
cancelled an
appointment on
22-JAN. Data
will be updated
ASAP.
Jan-27-2021
15:48:45
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Opened Clinical Please
submit stop
date when
molar
pregnancy is
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862915
Page 196 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
therapeutically
removed or
confirm
Miscarriage
completion date
- did
miscarriage
start and stop
on 20Nov20?
Jan-27-2021
15:48:01
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed rewording
Jan-22-2021
16:25:26
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened Clinical Please
submit stop
date when
molar
pregnancy is
therapeutically
removed
Jan-20-2021
17:08:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862916
Page 197 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Jan-20-2021
17:08:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Jan-25-2021
08:16:16
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Delet
edClose Auto Query
Jan-25-2021
04:33:27
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Clos
edResponse satisfies
query
Jan-24-2021
21:16:23
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Ans
weredNew Information
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862917
Page 198 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Jan-24-2021
21:16:23
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Is this seriou
s event assoc
iated with co
ngenital ano
maly or birth
defect?
NO
Did this serio
us event resu
lt in death?
NO
Did this serio
us event requ
ire or prolon
g hospitalizat
ion?
NO
Did this serio
us event resu
lt in persisten
t or significa
nt disability/i
ncapacity?
NONew Information
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862918
Page 199 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Is this seriou
s event life t
hreatening?
NO
Other medic
ally importan
t serious eve
nt
YES
Jan-22-2021
16:21:33
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Open
edClinical Event
Serious criteria are
Med
Important/Significant
and Congenital
anomaly Birth
defect; however,
SAE report criterion
is Med
Import/Signif. Please
review serious
criteria, harmonize
reporting, and update
in the appropriate
location.
Jan-20-2021
17:08:48
(UTC-03:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Cand
idateFor AE Molar
Pregnancy: Response
to "Is the adverse
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862919
Page 200 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
City of Buenos
Airesevent serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862920
Page 201 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Jan-20-2021
17:08:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event
associated with con
genital anomaly or b
irth defect?
YES
Did this serious eve
nt result in death?
NO
Did this serious eve
nt require or prolong
hospitalization?
NOInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862921
Page 202 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Did this serious eve
nt result in persisten
t or significant disab
ility/incapacity?
NO
Is this serious event
life threatening?
NO
Other medically imp
ortant serious event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-20-2021
17:08:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-20-2021
17:08:48ACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862922
Page 203 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City
of Buenos AiresIf Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
it is unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-20-2021
17:08:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-20-2021
17:08:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862923
Page 204 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Jan-20-2021
17:08:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-03-2021
17:00:46
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Close
dResponse satisfies
query
Mar-03-2021
10:21:39
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: Answ
eredNew Information
Mar-03-2021
10:21:39
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
RECOVERED/
RESOLVEDNew Information
Mar-02-2021
12:37:15
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Reiss
ued:OpenedClinical - this
OUTCOME is
the same report as
the End Date (ie
they must match;
End
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862924
Page 205 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date=Recovered),
which has been
entered as Jan21.
As the study
subject is the
father he can
report end of PG;
please add
Recovered to
match
Feb-25-2021
17:19:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Answ
eredInformation on
the subject's
partner cannot be
recorded because
I did not sign
consent for the
disclosure of data
of the pregnant
partner
Feb-22-2021
18:08:50
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Reiss
ued:OpenedClinical Thank
you; since the end
date is Unk Jan
2021, here in Feb
2021 the event is
resolved. Please
update for
resolution c/w
with reported end
date for the AE.
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862925
Page 206 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Feb-18-2021
03:13:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Close
dResponse satisfies
query
Feb-17-2021
12:06:23
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Answ
eredIt was requested
that we set the
end date Unk Jan
2021. The status
of the partner of
the volunatrium is
unknown because
they did not sign
informed consent
for the disclosure
of data. At the
moment we do
not have more
information.
Feb-17-2021
12:05:23
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Answ
eredThe volunteer and
his partner did not
sign a consent for
the disclosure of
pregnant partner
data. At the
moment there is
no more
information
available. It is
unknown when
we will have
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862926
Page 207 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
more information.
Feb-16-2021
01:28:47
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Opene
dClinical An End
date has been
entered for the
Event; please
update the
outcome to
resolved
Feb-15-2021
10:55:41
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Reiss
ued:OpenedDM2: Thank you
for response.
Please confirm by
when information
can be expected.
New query would
be issues on same
date.
Feb-15-2021
01:39:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Close
dResponse satisfies
query
Feb-13-2021
11:01:15
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Answ
eredOriginal value is
correct
Feb-13-2021
11:00:44ACV0PFEINFP6000  Query 2: Answ
eredThe volunteer and
his wife did not
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862927
Page 208 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00)
City of Buenos
Airessign a data release
consent. Multiple
calls were
attempted, it is
more they had a
turn for an
unscheduled visit
and they
canceled. So far
we have no more
data.
Feb-12-2021
19:36:13
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Reiss
ued:OpenedDM: For AE
Molar pregnancy
in partner:
Response to
"What was the
outcome of this
adverse event?" is
'Unknown' but
End Date/Time is
provided or "Is
the adverse event
still ongoing?" is
marked "Yes".
Please refer to
CRF CR 8.50.2.5
for specific
guidance.
Feb-12-2021
10:56:43
(UTC-03:00)ACV0PFEINFP6000  Query 2: Reiss
ued:OpenedDM: Please
review and
confirm if this
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862928
Page 209 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
City of Buenos
Airesdata will be
obtained in the
future or if its
Unknown.
Feb-12-2021
10:49:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Answ
eredFemale partner’s
Status : unknown.
This information
was sent on SAE
follow up form.
Thank you.
Feb-12-2021
10:43:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Opene
dFor AE Molar
pregnancy in
partner: Response
to "What was the
outcome of this
adverse event?" is
'Unknown' but
End Date/Time is
provided or "Is
the adverse event
still ongoing?" is
marked "Yes".
Feb-11-2021
17:47:32
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Answ
eredPartner status of
the volunteer:
unknown
Feb-11-2021
17:44:56ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opene
dFor AE Molar
Pregnancy:
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862929
Page 210 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00)
City of Buenos
AiresResponse to
"What was the
outcome of this
adverse event?" is
'Unknown' but
End Date/Time is
provided or "Is
the adverse event
still ongoing?" is
marked "Yes".
Jan-22-2021
05:29:08
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Close
dResponse satisfies
query
Jan-21-2021
05:22:36
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Santiago
CorradettiQuery 1: Answ
eredAs per CRF CR
(section 8.50.2.5),
as long as
pregnancy is
ongoing, outcome
must figure as
'unknown'. Thank
you.
Jan-20-2021
17:08:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opene
dFor AE Molar
Pregnancy:
Response to
"What was the
outcome of this
adverse event?" is
'Unknown' but
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862930
Page 211 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
End Date/Time is
provided or "Is
the adverse event
still ongoing?" is
marked "Yes".
Jan-20-2021
17:08:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
UNKNOWNInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-20-2021
17:08:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-25-2021
08:16:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2021050837Initial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862931
Page 212 of 228
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Feb-05-2021
14:05:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-05-2021
14:05:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-05-2021
14:05:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Drug exposed pregnan
cy ( female partner )Initial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862932
Page 213 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Feb-05-2021
14:05:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/20/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-17-2021
04:21:55
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Feb-12-2021
10:50:36
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Answere
dSAE safety
form was sent.
Feb-11-2021
18:32:13
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Reissued
:OpenedCLINICAL -
Thank you;
please update
SAE report
(#2021050637)
with the EDP
end date.
Feb-11-2021
17:52:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Answere
dNew
Information
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862933
Page 214 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Feb-11-2021
17:52:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/UNK/2021
UNK:UNKNew
Information
Feb-10-2021
10:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Opened CLINICAL -
End date for
partner
pregnancy is
UNK/UNK
/2021; since
original SAE
report was on
20Jan21, the
End date for
both partner PG
and molar
pregnancy was
UNK/Jan/2021.
Please update
on AE and SAE
report.
Feb-09-2021
20:21:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-09-2021
10:31:43ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dNew
Information
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862934
Page 215 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00)
City of Buenos
Aires
Feb-09-2021
10:31:43
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
UNK/UNK/20
21 UNK:UNKNew
Information
Feb-08-2021
08:39:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened DM: The
response for "Is
the adverse
event still
ongoing?" is
missing. Kindly
review and
update.
6. Toxicity Grade:
Date Location User Value Reason
Feb-11-2021
18:30:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-11-2021
17:50:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862935
Page 216 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Feb-11-2021
17:50:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered It is clarified
that the degree
of intensity is
not applicable.
Feb-11-2021
17:50:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry: It is clarified
that the degree
of intensity is
not applicable.
Feb-10-2021
10:18:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened Clinical As
per CRF CG
8.50.2.5, the
toxicity grade
for “Exposure
During
Pregnancy” is
reported as
Not
Applicable
Feb-05-2021
14:05:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862936
Page 217 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
prevent above outcomes).
Date Location User Value Reason
Feb-24-2021
03:08:31
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 2:
ClosedPer Clinical comment 'this
is correct for the event
'Maternal Exposure during
PG' - it is non-serious. (the
SAE event 'molar pregancy'
is the only one that is
serious).
Feb-21-2021
10:36:27
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 2:
Reissued:
CandidatePending Clinical review
Feb-19-2021
13:24:54
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 2:
AnsweredPregnancies are reported in
the SAE form but do not
correspond to a serious
adverse event.
Feb-19-2021
03:04:12
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 2:
OpenedSAE
RECON:AER#2021050837
DRUG EXPOSED
PREGNANCY reported as
serious in Safety database
while non serious in AE
CRF. Please confirm and
update CRF. If safety
update is required, submit a
follow-up SAE Form.
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862937
Page 218 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Feb-17-2021
04:22:58
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1:
ClosedResponse satisfies query
Feb-12-2021
10:52:08
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1:
AnsweredPregnancy exposed to
drugs does not correspond
to an SAE, for that reason
the severity criteria are not
stated. On the other hand,
molar pregnancy if it
corresponds to an SAE, for
which severity criteria were
recorded.
Feb-11-2021
16:56:49
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1:
OpenedClinical Serious criteria for
EDP are 'NO'; however, in
PG report/SAE for molar
pregnancy (#2021050837),
the box for Serious is
checked for EDP. Please
review, harmonize
reporting, and update in the
appropriate location.
Feb-05-2021
14:05:00
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data Ent
ry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862938
Page 219 of 228
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311635 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-05-2021
14:05:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-05-2021
14:05:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-05-2021
14:05:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2edf\Final\Final On: 01-Apr-2021 03:26 (GMT)
(b
…[truncated]