125742 S1 M5 CRF c4591001 1231 12313715

Document text

Page 1 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version30 JUN 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877056
Page 2 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/24/2020
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877057
Page 3 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Demography
1.Subject ID [12313715]
2.Birth Date: 1972
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877058
Page 4 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877059
Page 5 of 209
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion
criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55
years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years,
inclusive, at randomization (dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all
scheduled visits, vaccination plan, laboratory tests, lifestyle
considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN02A00
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877060
Page 6 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history,
physical examination, and clinical judgment of the investigator
to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which
includes compliance with the requirements and restrictions
listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past
year) or active suicidal ideation/behavior/lab abnormality that
may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX01A00
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877061
Page 7 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine
and/or severe allergic reaction (eg, anaphylaxis) to any
component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX04A00
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877062
Page 8 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or
laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged
bleeding that would, in the opinion of the investigator,
contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX11A00
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877063
Page 9 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as
cytotoxic agents or systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60
days before study intervention administration or planned
receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX14A01
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877064
Page 10 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention
within 28 days prior to study entry and/or during study
participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study
intervention containing lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in
the conduct of the study, site staff otherwise supervised by the
investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX21A01
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877065
Page 11 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877066
Page 12 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877067
Page 13 of 209
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [82.55]
3.Unit: kg
4.Height: [162.0]
5.Unit: cm
6.Body Mass Index: [31.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877068
Page 14 of 209
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/24/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877069
Page 15 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [64714]
3.Randomization Group: [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877070
Page 16 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BP2DM2]
5.bSample ID [BP2DM3]
5.cSample ID [BP2DM4]
5.dSample ID [BNTYK5]
5.eSample ID [BNTYK6]
5.fSample ID [BNTYK7]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877071
Page 17 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BP24MG]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877072
Page 18 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/24/2020 18:57
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
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877073
Page 19 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877074
Page 20 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/13/2020
2.Erroneous Visit
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877075
Page 21 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vital Signs
1.Date: Sep/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877076
Page 22 of 209
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/13/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877077
Page 23 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/13/2020
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 [BP1YKG]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877078
Page 24 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/13/2020 18:03
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
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877079
Page 25 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877080
Page 26 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
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 [BRXR1N]
5.bSample ID [BRXR23]
5.cSample ID [BP1NDK]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877081
Page 27 of 209
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/19/2021
2.Erroneous Visit
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877082
Page 28 of 209
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/19/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS1P31]
5.bSample ID [BS1P2T]
5.cSample ID [BR28ZG]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877083
Page 29 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877084
Page 30 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877085
Page 31 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877086
Page 32 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877087
Page 33 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877088
Page 34 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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: [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877089
Page 35 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877090
Page 36 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877091
Page 37 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877092
Page 38 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877093
Page 39 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877094
Page 40 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877095
Page 41 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877096
Page 42 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Unplanned Assessments
1.Assessments
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877097
Page 43 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877098
Page 44 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877099
Page 45 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877100
Page 46 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877101
Page 47 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877102
Page 48 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877103
Page 49 of 209
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877104
Page 50 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877105
Page 51 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877106
Page 52 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877107
Page 53 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877108
Page 54 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877109
Page 55 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877110
Page 56 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877111
Page 57 of 209
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877112
Page 58 of 209
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877113
Page 59 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#CategoryAE Iden
tifierAdverse Eve
ntStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Right Ankle
Fracture Jan/2/2021
10:00 NO
End Date Time:
Mar/1/2021 19:00
 Repeating
Pages
 2.ADVERSE
EVENT 2  Fall from ow
n height. Jan/2/2021
10:00 NO
End Date Time:
Jan/2/2021 10:00
 Repeating
Pages
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877114
Page 60 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Right Ankle Fracture]
4.Start Date Time: Jan/2/2021 10:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/1/2021 19:00
6.Toxicity Grade: 3
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877115
Page 61 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877116
Page 62 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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:
[trauma to the right ankle from falling from his own
height]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021002950]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877117
Page 63 of 209
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Fall from own height.]
4.Start Date Time: Jan/2/2021 10:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/2/2021 10:00
6.Toxicity Grade: 3
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877118
Page 64 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877119
Page 65 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877120
Page 66 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877121
Page 67 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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[ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877122
Page 68 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877123
Page 69 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877124
Page 70 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877125
Page 71 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877126
Page 72 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877127
Page 73 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877128
Page 74 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877129
Page 75 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877130
Page 76 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877131
Page 77 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877132
Page 78 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/11/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877133
Page 79 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877134
Page 80 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877135
Page 81 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/13/2020
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877136
Page 82 of 209
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877137
Page 83 of 209
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877138
Page 84 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
FormAug-24-2020 22:25:05 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0877139
Page 85 of 209
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-20-2021 10:31:27 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria
Beretta Approved Mar-17-2021 15:20:52 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, MariaBeretta, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877140
Page 86 of 209
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
 N/A Mar-03-2021 10:25:30 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-22-2021 15:42:20 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages
accurately display the results of the examinations, tests, evaluations and treatments performed on
this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-21-2021 13:30:42 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria
Beretta Approved Jan-21-2021 12:33:03 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877141
Page 87 of 209
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Affidavit:
By my dated signature below, I, MariaBeretta, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-03-2021 20:07:53 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-21-2020 22:42:59 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877142
Page 88 of 209
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Affidavit:
By my dated signature below, I, , verify that all case report form pages
accurately display the results of the examinations, tests, evaluations and treatments performed on
this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877143
Page 89 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-24-2020
22:23:44
(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-24-2020
22:23:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877144
Page 90 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-24-2020
22:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Aug/24/2020Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877145
Page 91 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-24-2020
18:06:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12313715Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-24-2020
18:06:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1972Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-24-2020
22:24:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-24-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0877146
Page 92 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
22:24:06
(UTC-03:00) City
of Buenos AiresHISPANIC OR LATI
NO(A) OR OF SPANI
SH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-24-2020
22:24:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877147
Page 93 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-24-2020
22:24:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877148
Page 94 of 209
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.a
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:1
Crit
erio
n D
escr
iptio
n:Male or female
participants bet
ween the ages o
f 18 and 55 year
s, inclusive, 65
and 85 years, in
clusive, or 18 a
nd 85 years, inc
lusive, at rando
mization (depen
dent upon study
stage)
Crit
erio
n m
et?:YESInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877149
Page 95 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female partici
pants between the age
s of 18 and 55 years, i
nclusive, 65 and 85 ye
ars, inclusive, or 18 an
d 85 years, inclusive,
at randomization (dep
endent upon study sta
ge)Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877150
Page 96 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.a Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(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-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n Nu
mbe
r:2Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877151
Page 97 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n De
scri
ptio
n:Participants wh
o are willing an
d able to compl
y with all sched
uled visits, vac
cination plan, l
aboratory tests,
lifestyle consid
erations, and ot
her study proce
dures
Crit
erio
n me
t?:YES
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN02A00
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877152
Page 98 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.b Inclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are w
illing and able to com
ply with all scheduled
visits, vaccination pla
n, laboratory tests, life
style considerations, a
nd other study proced
uresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877153
Page 99 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:Healthy partici
pants who are d
etermined by m
edical history, p
hysical examin
ation, and clinic
al judgment of t
he investigator
to be eligible fo
r inclusion in th
e study
Crit
erio
n m
et?:YESInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877154
Page 100 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN03A00
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877155
Page 101 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.c Inclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants w
ho are determined by
medical history, physi
cal examination, and c
linical judgment of the
investigator to be eligi
ble for inclusion in the
studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877156
Page 102 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n Nu
mbe
r:4
Crit
erio
n De
scrip
tion:Capable of givi
ng personal sig
ned informed c
onsent, which i
ncludes compli
ance with the re
quirements and
restrictions liste
d in the ICD an
d in this protoc
ol
Crit
erio
n me
t?:YESInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877157
Page 103 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN04A00
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877158
Page 104 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.d Inclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving pers
onal signed informed
consent, which includ
es compliance with th
e requirements and res
trictions listed in the I
CD and in this protoco
lInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877159
Page 105 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:1
Crit
erio
n De
scri
ptio
n:Other medical o
r psychiatric co
ndition incl. rec
ent (within past
year) or active s
uicidal ideation/
behavior/lab ab
normality that
may increase th
e risk of study p
articipation
Crit
erio
n m
et?:NOInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877160
Page 106 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psyc
hiatric condition incl.
recent (within past yea
r) or active suicidal id
eation/behavior/lab ab
normality that may inc
rease the risk of study
participationInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877161
Page 107 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.a Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:2Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877162
Page 108 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crite
rion
Descr
iptio
n:Known infecti
on with human
immunodefici
ency virus (HI
V), hepatitis C
virus (HCV),
or hepatitis B
virus (HBV)
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX02A00
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877163
Page 109 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.b Exclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection with
human immunodeficie
ncy virus (HIV), hepat
itis C virus (HCV), or
hepatitis B virus (HB
V)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877164
Page 110 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:3
Crit
erio
n De
scrip
tion:History of seve
re adverse react
ion associated
with a vaccine
and/or severe al
lergic reaction (
eg, anaphylaxis
) to any compo
nent of the stud
y intervention(s
)
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877165
Page 111 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX03A00
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877166
Page 112 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.c Exclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adve
rse reaction associated
with a vaccine and/or
severe allergic reactio
n (eg, anaphylaxis) to
any component of the
study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877167
Page 113 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:4
Criterio
n Descri
ption:Receipt of
medications
intended to
prevent CO
VID-19
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX04A00Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877168
Page 114 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.d Exclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medication
s intended to prevent
COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(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-24-2020
22:24:42
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877169
Page 115 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
of Buenos Aires
2.e
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:8
Crit
erio
n De
scrip
tion:Immunocompr
omised individ
uals with know
n or suspected i
mmunodeficien
cy, as determin
ed by history a
nd/or laborator
y/physical exa
mination
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0877170
Page 116 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX08A00
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877171
Page 117 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.e Exclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised
individuals with know
n or suspected immun
odeficiency, as determ
ined by history and/or
laboratory/physical ex
aminationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877172
Page 118 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:10
Crit
erio
n De
scrip
tion:Bleeding diathe
sis or condition
associated with
prolonged blee
ding that would
, in the opinion
of the investiga
tor, contraindic
ate intramuscul
ar injection
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877173
Page 119 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX10A00
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877174
Page 120 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.f Exclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or c
ondition associated wi
th prolonged bleeding
that would, in the opin
ion of the investigator,
contraindicate intramu
scular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877175
Page 121 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numbe
r:11
Criterion
Descripti
on:Women w
ho are pre
gnant or br
eastfeedin
g
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX11A00Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877176
Page 122 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.g Exclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are pregn
ant or breastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(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-24-2020
22:24:42
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877177
Page 123 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
of Buenos Aires
2.h
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:12
Criterio
n Descri
ption:Previous va
ccination w
ith any cor
onavirus va
ccine
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX12A00Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0877178
Page 124 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.h Exclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccination
with any coronavirus
vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(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-24-2020
22:24:42
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877179
Page 125 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
of Buenos Aires
2.i
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:13
Crite
rion
Descr
iption
:Subjects who
receive immu
nosuppressive
therapy, such
as cytotoxic a
gents or syste
mic corticoste
roids
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX13A01Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0877180
Page 126 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.i Exclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive i
mmunosuppressive th
erapy, such as cytotoxi
c agents or systemic c
orticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877181
Page 127 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:15
Crit
erio
n De
scrip
tion:Receipt of bloo
d/plasma produ
cts or immunog
lobulin, from 6
0 days before st
udy interventio
n administratio
n or planned re
ceipt throughou
t the study
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877182
Page 128 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX14A01
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877183
Page 129 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.j Exclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plas
ma products or immun
oglobulin, from 60 da
ys before study interve
ntion administration o
r planned receipt throu
ghout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877184
Page 130 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877185
Page 131 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
2.k
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:16
Crite
rion
Desc
ripti
on:Participation i
n other studies
involving stud
y intervention
within 28 days
prior to study
entry and/or d
uring study pa
rticipation
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX15A01Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877186
Page 132 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.k Exclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other
studies involving stud
y intervention within
28 days prior to study
entry and/or during st
udy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877187
Page 133 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Numb
er:17
Criter
ion D
escrip
tion:Previous parti
cipation in ot
her studies in
volving study
intervention c
ontaining lipi
d nanoparticl
es
Criter
ion m
et?:NOInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877188
Page 134 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criter
ion I
D: (F
or Pfi
zer us
e only
):EX16A01
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877189
Page 135 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.l Exclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participation
in other studies involv
ing study intervention
containing lipid nano
particlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877190
Page 136 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:22
Crit
erio
n De
scri
ptio
n:Investigator sit
e staff or Pfizer
employees dire
ctly involved in
the conduct of t
he study, site st
aff otherwise s
upervised by th
e investigator, a
nd their respect
ive family mem
bers
Crit
erio
n m
et?:NOInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877191
Page 137 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX21A01
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877192
Page 138 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.m Exclusion Number:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff
or Pfizer employees d
irectly involved in the
conduct of the study, s
ite staff otherwise sup
ervised by the investi
gator, and their respec
tive family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877193
Page 139 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-24-2020
22:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877194
Page 140 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-24-2020
22:24:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-24-2020
22:24:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-24-2020
22:24:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877195
Page 141 of 209
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date:
Date Location User Value Reason
Aug-24-2020
22:25:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-24-2020
22:25:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
82.55Initial Entry
3. Unit:
Date Location User Value Reason
Aug-24-2020
22:25:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877196
Page 142 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-24-2020
22:25:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
162.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-24-2020
22:25:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-24-2020
22:25:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.5Initial Entry
7.a
Date Location User Value Reason
Aug-24-2020
22:25:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.8Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877197
Page 143 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Temperatur
e Unit:C
Temperatur
e Location:
:ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-24-2020
22:25:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-24-2020
22:25:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-24-2020
22:25:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877198
Page 144 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
7.a Temperature Location:
Date Location User Value Reason
Aug-24-2020
22:25:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877199
Page 145 of 209
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-24-2020
22:25:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-24-2020
22:25:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-24-2020
22:25:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877200
Page 146 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-24-2020
22:25:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-24-2020
22:25:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-24-2020
22:25:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877201
Page 147 of 209
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-24-2020
22:25:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-24-2020
22:25:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-24-2020
22:25:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877202
Page 148 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-24-2020
22:26:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-24-2020
22:26:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
64714Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877203
Page 149 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020
22:26:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020
22:26:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020
10:17:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-25-2020
03:42:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877204
Page 150 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
are entered.
Please review
and correct as
appropriate.
Aug-24-2020
22:26:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-24-2020
22:26:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020
10:17:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample I
D:BP2DM
2Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877205
Page 151 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-25-2020
10:17:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BP2DM2Initial Entry
5.b
Date Location User Value Reason
Aug-25-2020
10:17:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample I
D:BP2DM
3Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-25-2020
10:17:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BP2DM3Initial Entry
5.c
Date Location User Value Reason
Aug-25-2020
10:17:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample I
D:BP2DM
4Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877206
Page 152 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.c Sample ID
Date Location User Value Reason
Aug-25-2020
10:17:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BP2DM4Initial Entry
5.d
Date Location User Value Reason
Aug-25-2020
15:12:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BNTYK
5Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-25-2020
15:12:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTYK5Initial Entry
5.e
Date Location User Value Reason
Aug-25-2020
15:12:46
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Sample I
D:BNTYK
6Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877207
Page 153 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
of Buenos Aires
5.e Sample ID
Date Location User Value Reason
Aug-25-2020
15:12:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTYK6Initial Entry
5.f
Date Location User Value Reason
Aug-25-2020
15:13:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BNTYK
7Initial Entry
5.f Sample ID
Date Location User Value Reason
Aug-25-2020
15:13:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTYK7Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877208
Page 154 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020
22:26:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020
22:26:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020
13:06:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-25-2020
03:42:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877209
Page 155 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
are entered.
Please review
and correct as
appropriate.
Aug-24-2020
22:26:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-24-2020
22:26:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020
13:06:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample I
D:BP24M
GInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877210
Page 156 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-25-2020
13:06:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BP24MGInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877211
Page 157 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-24-2020
22:26:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-24-2020
22:26:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-24-2020
22:26:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-24-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0877212
Page 158 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
22:26:46
(UTC-03:00) City
of Buenos AiresAug/24/2020 18:57
5. Anatomical Location:
Date Location User Value Reason
Aug-24-2020
22:26:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-24-2020
22:26:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-24-2020
22:26:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877213
Page 159 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-24-2020
22:26:46
(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-24-2020
22:26:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877214
Page 160 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-24-2020
22:26:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877215
Page 161 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-13-2020
19:05:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/13/2020Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877216
Page 162 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date:
Date Location User Value Reason
Sep-13-2020
19:05:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/13/2020Initial Entry
2.a
Date Location User Value Reason
Sep-13-2020
19:05:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Record Ide
ntifier::1
Temperatu
re:37.3
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-13-2020
19:05:35
(UTC-03:00) CityACV0PFEINFP6000  Martina
DavalliData Entry:
1Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877217
Page 163 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
of Buenos Aires
2.a Temperature:
Date Location User Value Reason
Sep-13-2020
19:05:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
37.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-13-2020
19:05:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-13-2020
19:05:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
ORAL CAVITYInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877218
Page 164 of 209
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-13-2020
19:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-13-2020
19:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-13-2020
19:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/13/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877219
Page 165 of 209
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Sep-13-2020
19:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-13-2020
19:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-13-2020
19:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877220
Page 166 of 209
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Sep-13-2020
19:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-13-2020
19:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-13-2020
19:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NEGATIVEInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877221
Page 167 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-13-2020
19:05:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-13-2020
19:05:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020
11:45:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-14-2020
02:38:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0877222
Page 168 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
are entered.
Please review
and correct as
appropriate.
Sep-13-2020
19:05:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-13-2020
19:05:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Date of Collection
:
Sep/13/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020
11:45:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BP1YK
GInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877223
Page 169 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Sep-14-2020
11:45:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP1YKGInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0877224
Page 170 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-13-2020
19:06:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-13-2020
19:06:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-13-2020
19:06:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-13-2020 ACV0PFEINFP6000  Martina Data Entry: Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877225
Page 171 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
19:06:03
(UTC-03:00) City
of Buenos AiresDavalli Sep/13/2020 18:03
5. Anatomical Location:
Date Location User Value Reason
Sep-13-2020
19:06:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-13-2020
19:06:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-13-2020
19:06:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877226
Page 172 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Sep-13-2020
19:06:03
(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-13-2020
19:06:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877227
Page 173 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020
08:32:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0877228
Page 174 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
08:33:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
08:33:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020
10:17:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-14-2020
08:33:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877229
Page 175 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
08:33:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020
10:17:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRXR1
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020
10:17:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRXR1NInitial Entry
5.b
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877230
Page 176 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Oct-14-2020
11:56:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BRXR2
3Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020
11:56:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRXR23Initial Entry
5.c
Date Location User Value Reason
Oct-14-2020
12:39:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Sample I
D:BP1ND
KInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-14-2020
12:39:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
BP1NDKInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877231
Page 177 of 209
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-20-2021
10:31:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/19/2021Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0877232
Page 178 of 209
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-20-2021
10:32:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-20-2021
10:32:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-20-2021
13:40:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-20-2021
10:32:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877233
Page 179 of 209
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
are entered.
Please review
and correct as
appropriate.
Mar-20-2021
10:32:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/19/2021Initial Entry
5.a
Date Location User Value Reason
Mar-20-2021
13:40:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BS1P3
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-20-2021
13:40:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS1P31Initial Entry
5.b
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0877234
Page 180 of 209
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Mar-20-2021
15:28:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BS1P2
TInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-20-2021
15:28:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS1P2TInitial Entry
5.c
Date Location User Value Reason
Mar-20-2021
15:31:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BR28Z
GInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-20-2021
15:31:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BR28ZGInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877235
Page 181 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-14-2020
08:33:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020
08:33:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020
08:33:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0877236
Page 182 of 209
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-11-2021
16:03:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/11/2021Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877237
Page 183 of 209
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-11-2021
16:05:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-11-2021
16:03:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Mar-11-2021
16:03:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willin
g to return for Vacci
nation 3
Participant is:
eligible and NO
T confirmed to h
ave received onlInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877238
Page 184 of 209
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
y placebo at Vac
cination 1/2
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877239
Page 185 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Date Location User Value Reason
Jan-03-2021
20:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877240
Page 186 of 209
***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: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Date Location User Value Reason
Jan-08-2021
12:28:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877241
Page 187 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Category:
Date Location User Value Reason
Jan-03-2021
20:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-03-2021
20:07:53
(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
Jan-26-2021
01:03:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Close
dResponse
satisfies query
Jan-18-2021
12:39:54
(UTC-03:00)ACV0PFEINFP6000  Query 2: Answ
eredSAE follow up
form was sent.
It's clarify the
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0877242
Page 188 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
City of Buenos
Airessurgery was
performed in
Sanatorio
Argentino de La
Plata and no
surgery was
performed in
Sanatorio Mater
Dei.
Jan-08-2021
17:04:01
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Giselle Castillo Query 1: Close
dThanks!
Jan-08-2021
12:30:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answ
eredform updated.
thank you
Jan-08-2021
11:04:38
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Opene
dCLINICAL
SAE report
notes that
subject is
awaiting
transfer to
another hosp for
FURTHER
surgery;
however, it does
not state that the
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877243
Page 189 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
subject had a
FIRST surgery
in the original
hosp. Please
update with
surgery
information.
Jan-06-2021
21:27:33
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Giselle Castillo Query 1: Opene
dClinical_ If the
traumatic
accident was
either a fall ...,
then fall needs
to be reported
recorded as AEs
as well, even if
an injury did not
result. See
specific CRF
completion
guidelines
(8.50.2.2./falls).
Thank you
Jan-03-2021
20:07:53
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Right Ankle Fra
ctureInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877244
Page 190 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Jan-03-2021
20:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/2/2021 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-03-2021
10:25:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Mar/1/2021 19:00New
Information
Jan-03-2021
20:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-03-2021
20:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877245
Page 191 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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-05-2021
08:31:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Closed event reported in
SDB
Jan-04-2021
08:07:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Opened SAE
RECON:Right
Ankle
Fracture(Onset
date:02Jan2021)
is not reported to
Safety database
but marked
serious on AE
CRF. Confirm
seriousness and
report to Pfizer
immediately. If
this event is not
serious,
downgrade the
event on AE
CRF
Jan-04-2021
08:02:41ACV0PFEINFP6000  Query 1: Deleted Query can be
addressed
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0877246
Page 192 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
(UTC-03:00) City
of Buenos Airesinternally
Jan-03-2021
20:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Right
Ankle Fracture:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Jan-03-2021
20:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious eve
nt associated with
congenital anomal
y or birth defect?
NO
Did this serious ev
ent result in death?
NO
Did this serious ev
ent require or prol
ong hospitalizatio
n?Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0877247
Page 193 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
YES
Did this serious ev
ent result in persist
ent or significant d
isability/incapacity
?
NO
Is this serious eve
nt life threatening?
NO
Other medically i
mportant serious e
vent
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.
Date Location User Value Reason
Jan-03-2021
20:08:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877248
Page 194 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Jan-03-2021
20:07:53
(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:
trauma to the rig
ht ankle from fall
ing from his own
heightInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-03-2021
20:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-03-2021
20:07:53
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877249
Page 195 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
of Buenos Aires
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-03-2021
10:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESNew
Information
Jan-03-2021
20:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Mar-08-2021
05:29:17
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Quer
y 3:
Close
dSDB updated
Mar-04-2021
16:15:46
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Quer
y 3:
Reiss
ued:C
andid
atePending SDB update
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0877250
Page 196 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Mar-04-2021
10:25:08
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Quer
y 3:
Answ
eredOn 03MAR, FU was sent referring
to the fact that the event was
considered recovered with sequelae,
and bullet 17 was updated by
selecting the same option.
Mar-04-2021
06:29:29
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Quer
y 3:
Open
edSAE RECON:AER#2020385783
outcome was updated to
RECOVERED/RESOLVED WITH
SEQUELAE on AE CRF while
reported as Recovering/Resolving in
Safety database. Please confirm
correct outcome. If safety update is
required, please submit a follow-up
form.
Mar-03-2021
10:26:09
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Quer
y 2:
Close
dClose Auto Query
Mar-03-2021
10:26:09
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entr
y:
REC
OVE
RED/
RES
OLV
EDNew Information
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0877251
Page 197 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
WIT
H SE
QUE
LAE
Mar-03-2021
10:25:56
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Quer
y 2:
Open
edFor AE Right Ankle Fracture:
Response to "What was the outcome
of this adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Jan-22-2021
15:07:27
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Quer
y 1:
Close
dResponse satisfies query
Jan-21-2021
13:30:42
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Quer
y 1:
Answ
eredNew Information
Jan-21-2021
13:30:42
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entr
y:
REC
OVE
RIN
G/RENew Information
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0877252
Page 198 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
SOL
VIN
G
Jan-21-2021
00:24:14
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Quer
y 1:
Open
edSAE
RECON:AER#2021002950,outcome
was reported as
Recovering/Resolving to Safety DB
however, recorded as NOT
RECOVERED/NOT RESOLVED
on AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Jan-03-2021
20:07:53
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entr
y:
NOT
REC
OVE
RED/
NOT
RES
OLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-03-2021
20:07:53ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0877253
Page 199 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
(UTC-03:00) City
of Buenos Aires
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-05-2021
08:30:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2021002950Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0877254
Page 200 of 209
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Category:
Date Location User Value Reason
Jan-08-2021
12:28:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-08-2021
12:28:56
(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
Jan-08-2021
12:28:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Fall from own height.Initial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877255
Page 201 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Jan-08-2021
12:28:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/2/2021 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-22-2021
12:32:08
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/2/2021 10
:00New
Information
Jan-08-2021
12:28:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-08-2021
12:28:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877256
Page 202 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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-08-2021
12:28:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
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-08-2021
12:28:56
(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-08-2021
13:35:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), th
is event is due to:New
Information
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0877257
Page 203 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
OTHER
If Other, specify
:
unknown
Jan-08-2021
12:28:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), th
is event is due to:
OTHERInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-08-2021
12:28:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-08-2021
12:28:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877258
Page 204 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-08-2021
12:28:56
(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
Jan-22-2021
12:59:52
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-22-2021
12:59:52
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
RECOVERED/
RESOLVEDNew
Information
Jan-22-2021
12:32:08
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opene
dFor AE Fall
from own
height.:
Response to
"What was the
outcome of this
adverse event?"
is 'Not
Recovered/Not
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877259
Page 205 of 209
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Resolved' but
AE End
Date/Time is
present.
Jan-08-2021
12:28:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RECOVE
RED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-08-2021
12:28:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877260
Page 206 of 209
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-11-2021
16:05:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/11/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-11-2021
16:05:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877261
Page 207 of 209
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-14-2020
08:33:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-24-2020
22:26:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-24-2020
22:24:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-14-2020
08:33:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/13/2020Initial Entry
Aug-24-2020
22:26:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/24/2020Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877262
Page 208 of 209
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-24-2020
22:24:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/24/2020Initial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877263
Page 209 of 209
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313715 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020
22:42:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to Enabl
eInitial Entry
090177e196ae2e98\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0877264