125742 S1 M5 CRF c4591001 1231 12311510

Document text

Page 1 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option
is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861983
Page 2 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/16/2020
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861984
Page 3 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12311510]
2.Birth Date: /1955
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861985
Page 4 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/16/2020
2.Erroneous Visit
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861986
Page 5 of 145
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study
stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits, vaccination plan,
laboratory tests, lifestyle considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
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
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861987
Page 6 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction
(eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
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
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861988
Page 7 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
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
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861989
Page 8 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861990
Page 9 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: Jul/6/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Nephrolithiasis]
Start Date: Jul/6/2011
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Dyslipidemia]
Start Date: Jul/6/2014
Ongoing: YES
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861991
Page 10 of 145
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/16/2020
2.Weight: [83.0]
3.Unit: kg
4.Height: [189.0]
5.Unit: cm
6.Body Mass Index: [23.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [35.9] Comments
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861992
Page 11 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/16/2020
2.Randomization Number: [229708]
3.Randomization Group: [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861993
Page 12 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/16/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP144M]
5.bSample ID [BP144N]
5.cSample ID [BP144P]
5.dSample ID [BLD3LG]
5.eSample ID [BLD3LH]
5 fSample ID [BLD3LJ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861994
Page 13 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/16/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP14YD]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861995
Page 14 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/16/2020 11:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861996
Page 15 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861997
Page 16 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/7/2020
2.Erroneous Visit
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861998
Page 17 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861999
Page 18 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/7/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1TDY]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862000
Page 19 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/7/2020 10:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862001
Page 20 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862002
Page 21 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
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 [BLBY6Z]
5.bSample ID [BK6XPS]
5.cSample ID [BK6XT6]
5.dSample ID [BP1VHH]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862003
Page 22 of 145
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862004
Page 23 of 145
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862005
Page 24 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862006
Page 25 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862007
Page 26 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862008
Page 27 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862009
Page 28 of 145
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862010
Page 29 of 145
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862011
Page 30 of 145
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862012
Page 31 of 145
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862013
Page 32 of 145
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Health Care Utilization
1.Physician or Healthcare Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due to
potential COVID-19 illness?
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862014
Page 33 of 145
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862015
Page 34 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862016
Page 35 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862017
Page 36 of 145
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862018
Page 37 of 145
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862019
Page 38 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862020
Page 39 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862021
Page 40 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862022
Page 41 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862023
Page 42 of 145
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862024
Page 43 of 145
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862025
Page 44 of 145
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862026
Page 45 of 145
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862027
Page 46 of 145
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862028
Page 47 of 145
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862029
Page 48 of 145
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862030
Page 49 of 145
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862031
Page 50 of 145
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862032
Page 51 of 145
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862033
Page 52 of 145
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862034
Page 53 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Portosplenomesenteric venous thrombosis  Mar/3/2021
10:00 YES  Repeating
Pages
 2.ADVERSE E
VENT 2  Well-differentiated multifocal neuroendocrine
tumor of the stomach Jan/2/2021 1
0:00 YES  Repeating
Pages
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862035
Page 54 of 145
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Portosplenomesenteric venous thrombosis]
4.Start Date Time: Mar/3/2021 10:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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:
[Well-differentiated multifocal neuroendocrine tumor of the stomach]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862036
Page 55 of 145
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021243346]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862037
Page 56 of 145
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Well-differentiated multifocal neuroendocrine tumor of the stomach]
4.Start Date Time: Jan/2/2021 10:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862038
Page 57 of 145
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT 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[2021313526]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862039
Page 58 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Acti
onForm Instance
 1.          Repeating Pages
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862040
Page 59 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of Medication
Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862041
Page 60 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Iden
tifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862042
Page 61 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862043
Page 62 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionDose Descrip
tionForm Instance
 1.          Repeating
Pages
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862044
Page 63 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862045
Page 64 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862046
Page 65 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862047
Page 66 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
 1.     Repeating Pages
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862048
Page 67 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862049
Page 68 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862050
Page 69 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Booster Dose Trigger Form
1.Select appropriate response - Will the
participant return for consent/eligibility
assessment for the booster dose visit?
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862051
Page 70 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862052
Page 71 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862053
Page 72 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862054
Page 73 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/6/2020
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862055
Page 74 of 145
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862056
Page 75 of 145
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862057
Page 76 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
7.aAug-17-2020 14:31:44 (UTC-03:00) City of Buenos
AiresMabel Berrueta It is not clinically significant regarding medical record
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862058
Page 77 of 145
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
  N/A Mar-26-2021 10:29:28 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-23-2021 12:20:19 (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 Mar-20-2021 11:20:49 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-17-2021 18:58:15 (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 Mar-08-2021 02:41:37 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862059
Page 78 of 145
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
 Approved Mar-05-2021 15:06:21 (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 Mar-04-2021 17:30:46 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria Beretta  Approved Jan-21-2021 11:51:01 (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.
 N/A Jan-12-2021 15:50:31 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando Polack  Approved Oct-22-2020 16:36:36 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862060
Page 79 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-16-2020 13:48:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-16-2020 13:48:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862061
Page 80 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-16-2020 13:49:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/16/2020Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862062
Page 81 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-16-2020 10:03:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12311510Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-16-2020 10:03:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1955Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-16-2020 13:49:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-16-2020 13:49:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF SPA
NISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-16-2020 13:49:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862063
Page 82 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-16-2020 13:49:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/16/2020Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862064
Page 83 of 145
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants bet
ween the ages of 18 and 55 year
s, inclusive, 65 and 85 years, in
clusive, or 18 and 85 years, incl
usive, at randomization (depend
ent upon study stage)
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Male or female participants between the a
ges of 18 and 55 years, inclusive, 65 and
85 years, inclusive, or 18 and 85 years, in
clusive, at randomization (dependent upo
n study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862065
Page 84 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusio
n Numb
er:2
Criterio
n Descr
iption:Participants who are willing an
d able to comply with all sched
uled visits, vaccination plan, la
boratory tests, lifestyle conside
rations, and other study proced
ures
Criterio
n met?:YES
Criterio
n ID: (F
or Pfize
r use on
ly):IN02A00Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862066
Page 85 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Inclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participants who are willing and able to c
omply with all scheduled visits, vaccinati
on plan, laboratory tests, lifestyle conside
rations, and other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusio
n Num
ber:3
Criterio
n Descr
iption:Healthy participants who are d
etermined by medical history, p
hysical examination, and clinic
al judgment of the investigator
to be eligible for inclusion in th
e study
Criterio
n met?:YESInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862067
Page 86 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n ID: (F
or Pfize
r use on
ly):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Healthy participants who are determined
by medical history, physical examination,
and clinical judgment of the investigator t
o be eligible for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusio
n Numb
er:4
Criterio
n Descri
ption:Capable of giving personal sig
ned informed consent, which i
ncludes compliance with the re
quirements and restrictions list
ed in the ICD and in this proto
colInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862068
Page 87 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n met?:YES
Criterio
n ID: (F
or Pfize
r use on
ly):IN04A00
1.d Inclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Capable of giving personal signed inform
ed consent, which includes compliance w
ith the requirements and restrictions liste
d in the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:1Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862069
Page 88 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Desc
ription:Other medical or psychiatric co
ndition incl. recent (within past
year) or active suicidal ideation
/behavior/lab abnormality that
may increase the risk of study p
articipation
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Other medical or psychiatric condition in
cl. recent (within past year) or active suic
idal ideation/behavior/lab abnormality th
at may increase the risk of study participa
tionInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(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-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862070
Page 89 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:2
Criterion
Descripti
on:Known infection with human
immunodeficiency virus (HI
V), hepatitis C virus (HCV),
or hepatitis B virus (HBV)
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX02A00Initial Entry
2.b Exclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Known infection with human immunodef
iciency virus (HIV), hepatitis C virus (H
CV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num3Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862071
Page 90 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
ber:
Criterio
n Descri
ption:History of severe adverse react
ion associated with a vaccine a
nd/or severe allergic reaction (
eg, anaphylaxis) to any compo
nent of the study intervention(s
)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
History of severe adverse reaction associ
ated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any compon
ent of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862072
Page 91 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion Num
ber:4
Criterion Desc
ription:Receipt of medications
intended to prevent CO
VID-19
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX04A00Initial Entry
2.d Exclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Receipt of medications intended to preve
nt COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:8Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862073
Page 92 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n Descri
ption:Immunocompromised individu
als with known or suspected i
mmunodeficiency, as determin
ed by history and/or laboratory
/physical examination
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Immunocompromised individuals with k
nown or suspected immunodeficiency, as
determined by history and/or laboratory/p
hysical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb10Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862074
Page 93 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
er:
Criterio
n Descri
ption:Bleeding diathesis or condition
associated with prolonged blee
ding that would, in the opinion
of the investigator, contraindic
ate intramuscular injection
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition associate
d with prolonged bleeding that would, in
the opinion of the investigator, contraindi
cate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry:
Exclusion Numbe 11Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862075
Page 94 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aires r:
Criterion Descrip
tion:Women who are preg
nant or breastfeeding
Criterion met?: NO
Criterion ID: (Fo
r Pfizer use only)
:EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Women who are pregnant or breastfeedin
gInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion Num
ber:12
Criterion Descr
iption:Previous vaccination
with any coronavirus v
accine
Criterion met?: NOInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862076
Page 95 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion ID: (F
or Pfizer use on
ly):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Previous vaccination with any coronaviru
s vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:13
Criterion
Descriptio
n:Subjects who receive immu
nosuppressive therapy, such
as cytotoxic agents or syste
mic corticosteroids
Criterion
met?:NO
Criterion
ID: (For P
fizer use o
nly):EX13A01Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862077
Page 96 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.i Exclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Subjects who receive immunosuppressive
therapy, such as cytotoxic agents or syste
mic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:15
Criterio
n Descri
ption:Receipt of blood/plasma produ
cts or immunoglobulin, from 6
0 days before study interventio
n administration or planned rec
eipt throughout the study
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX14A01Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862078
Page 97 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.j Exclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products or imm
unoglobulin, from 60 days before study i
ntervention administration or planned rec
eipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862079
Page 98 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.k
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numbe
r:16
Criterion
Descripti
on:Participation in other studies
involving study intervention
within 28 days prior to study
entry and/or during study part
icipation
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX15A01Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862080
Page 99 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Exclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participation in other studies involving st
udy intervention within 28 days prior to s
tudy entry and/or during study participati
onInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in ot
her studies involving study
intervention containing lipi
d nanoparticles
Criterion
met?:NO
Criterion I
D: (For Pfi
zer use onl
y):EX16A01Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862081
Page 100 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.l Exclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Previous participation in other studies in
volving study intervention containing lipi
d nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:22
Criteri
on Des
criptio
n:Investigator site staff or Pfizer
employees directly involved in
the conduct of the study, site st
aff otherwise supervised by the
investigator, and their respectiv
e family members
Criteri
on met
?:NOInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862082
Page 101 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on ID:
(For Pf
izer use
only):EX21A01
2.m Exclusion Number:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer employee
s directly involved in the conduct of the s
tudy, site staff otherwise supervised by th
e investigator, and their respective family
membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 13:49:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862083
Page 102 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-16-2020 13:50:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-16-2020 13:50:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-16-2020 13:50:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862084
Page 103 of 145
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-16-2020 13:51:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term: Hypertension
Start Date: Jul/6/2014
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-16-2020 13:51:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-16-2020 13:51:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-16-2020 13:51:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Jul/6/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-16-2020 13:51:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-16-2020 13:52:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Term: Nephrolithiasis
Start Date: Jul/6/2011
Ongoing: YESInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862085
Page 104 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Line/MH Number:
Date Location User Value Reason
Aug-16-2020 13:52:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-16-2020 13:52:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NephrolithiasisInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-16-2020 13:52:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Jul/6/2011Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-16-2020 13:52:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Mar-05-2021 10:05:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term: Dyslipidemia
Start Date: Jul/6/2014
Ongoing: YESInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862086
Page 105 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Line/MH Number:
Date Location User Value Reason
Mar-05-2021 10:05:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-05-2021 10:05:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
DyslipidemiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Mar-05-2021 10:05:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Jul/6/2014Initial Entry
1.c Ongoing:
Date Location User Value Reason
Mar-05-2021 10:05:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862087
Page 106 of 145
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Aug-16-2020 13:53:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-16-2020 13:53:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
83.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-16-2020 13:53:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-16-2020 13:53:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
189.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-16-2020 13:53:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-16-2020 13:53:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.2Initial Entry
7.a
Date Location User Value Reason
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862088
Page 107 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020 13:53:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 35.9
Temperature Unit: C
Temperature Location
::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-16-2020 13:53:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-17-2020 15:40:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-17-2020 14:32:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Mabel Berrueta Query 1: Answered It is not clinically
significant
Aug-17-2020 13:16:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Reissued:Opened DM Query: Thank you
for your response
however please
confirm if clinically
significant or not.
Aug-16-2020 14:02:25
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Answered Original value is
correct
Aug-16-2020 13:53:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 35.9 C is
outside of Normal
Range 36.1 - 37.5 C.
Aug-16-2020 13:53:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
35.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-16-2020 13:53:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862089
Page 108 of 145
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020 13:53:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862090
Page 109 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-16-2020 13:56:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-16-2020 13:56:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
229708Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862091
Page 110 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-16-2020 13:56:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-16-2020 13:56:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020 12:45:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-16-2020 13:56:33
(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-16-2020 13:56:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/16/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020 12:45:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP144MInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-17-2020 12:45:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP144MInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862092
Page 111 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.b
Date Location User Value Reason
Aug-17-2020 12:45:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP144NInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-17-2020 12:45:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP144NInitial Entry
5.c
Date Location User Value Reason
Aug-17-2020 12:46:06
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP144PInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-17-2020 12:46:06
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP144PInitial Entry
5.d
Date Location User Value Reason
Aug-18-2020 14:47:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLD3LGInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-18-2020 14:47:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BLD3LGInitial Entry
5.e
Date Location User Value Reason
Aug-18-2020 14:48:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLD3LHInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862093
Page 112 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.e Sample ID
Date Location User Value Reason
Aug-18-2020 14:48:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BLD3LHInitial Entry
5.f
Date Location User Value Reason
Aug-18-2020 14:48:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLD3LJInitial Entry
5.f Sample ID
Date Location User Value Reason
Aug-18-2020 14:48:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BLD3LJInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862094
Page 113 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-16-2020 13:56:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-16-2020 13:56:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020 11:48:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-16-2020 13:56:48
(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-16-2020 13:56:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/16/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020 11:48:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP14YDInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-17-2020 11:48:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP14YDInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862095
Page 114 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-16-2020 13:57:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-16-2020 13:57:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-16-2020 13:57:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-16-2020 13:57:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/16/2020 11:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-16-2020 13:57:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-16-2020 13:57:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862096
Page 115 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020 13:57:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-16-2020 13:57:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-16-2020 13:57:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862097
Page 116 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-02-2020 11:31:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY N
OT COLLECTED FOR THIS SUBJEC
TChanged Information
Aug-16-2020 13:57:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIARY
COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862098
Page 117 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-07-2020 11:28:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862099
Page 118 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Sep-07-2020 11:28:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
2.a
Date Location User Value Reason
Sep-07-2020 11:28:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.3
Temperature Unit: C
Temperature Location
::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-07-2020 11:28:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-07-2020 11:28:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
36.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-07-2020 11:28:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-07-2020 11:28:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862100
Page 119 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020 11:28:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020 11:28:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020 09:21:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-08-2020 06:07:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-07-2020 11:28:46
(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-07-2020 11:28:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/7/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 09:21:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP1TDYInitial Entry
5.a Sample ID
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862101
Page 120 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Sep-08-2020 09:21:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP1TDYInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862102
Page 121 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-07-2020 11:29:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-07-2020 11:29:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-07-2020 11:29:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-07-2020 11:29:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/7/2020 10:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-07-2020 11:29:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-07-2020 11:29:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862103
Page 122 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-07-2020 11:29:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-07-2020 11:29:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION 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-07-2020 11:29:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862104
Page 123 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020 10:50:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Nicole
ZalchendlerQuery 1: Closed Response satisfies
query
Oct-20-2020 10:47:06
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Answered SYMPRDATE form is
not applicable to this ID
Oct-08-2020 18:42:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened Please review and
complete
VACCINATION
SYMPTOMS DIARY -
SYMPTOM
RESOLVED DATES
page thanks
Oct-06-2020 10:05:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862105
Page 124 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 10:05:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 10:05:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020 12:07:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-06-2020 10:13:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-06-2020 10:05:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-06-2020 10:05:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020 12:07:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BLBY6ZInitial Entry
5.a Sample ID
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862106
Page 125 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Oct-06-2020 12:07:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BLBY6ZInitial Entry
5.b
Date Location User Value Reason
Oct-06-2020 12:07:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BK6XPSInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-06-2020 12:07:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BK6XPSInitial Entry
5.c
Date Location User Value Reason
Oct-06-2020 12:10:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BK6XT6Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-06-2020 12:10:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BK6XT6Initial Entry
5.d
Date Location User Value Reason
Oct-06-2020 13:51:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP1VHHInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862107
Page 126 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.d Sample ID
Date Location User Value Reason
Oct-06-2020 13:51:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP1VHHInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862108
Page 127 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-09-2020 22:03:15
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020 22:03:15
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020 22:03:15
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862109
Page 128 of 145
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-12-2021 15:50:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Jan/12/2021Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862110
Page 129 of 145
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-13-2021 12:52:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-13-2021 02:00:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened The response indicates
participant was
unblinded, however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Jan-12-2021 15:50:46
(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.
Jan-12-2021 15:50:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participant is willing to return for Vacci
nation 3
Participant is:
eligible and NOT confirmed to have
received only placebo at Vaccinatio
n 1/2Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862111
Page 130 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Mar-04-2021 17:30:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862112
Page 131 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Mar-20-2021 11:24:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862113
Page 132 of 145
***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, Answered Queries
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Mar-04-2021 17:30:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-04-2021 17:30:46
(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 ValueReason
Mar-29-2021
10:33:28
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
4: Ans
weredIn the initial SAE, it is reported
that the volunteer began in
January 2021 with symptoms
(abdominal pain, weight loss of
approximately 7 kg), and the
histopathology diagnosis was
made in March 2021.
Mar-27-2021
15:03:42
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
4: Op
enedClinical - please submit a SAE
(#2021243346) update to report
the Past med hx of Carcinoid
(started Jan 2021)
Mar-20-2021
11:20:49
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
3: Del
etedNew Information
Mar-20-2021
11:20:49
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Portos
pleno
mesen
teric v
enous
throm
bosisNew Information
Mar-13-2021
13:01:42ACV0PFEINFP6000  Query
3: ReiThe volunteer was repeatedly
urged to provide study reports in
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862114
Page 133 of 145
***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, Answered Queries
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00)
City of
Buenos Airesssued:
Candi
dateorder to clarify the diagnosis.
The volunteer has not yet sent
the results.
Mar-11-2021
16:04:04
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
3: Ans
weredThe volunteer was repeatedly
urged to provide study reports in
order to clarify the diagnosis.
The volunteer has not yet sent
the results.
Mar-10-2021
20:48:44
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Clo
sedadditional query might be sent
Mar-10-2021
19:20:46
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
3: Op
enedClarify PORTO-SPLENIC
THROMBOSIS as follows...The
term appears incomplete. Are
you reporting
PORTOSPLENOMESENTERIC
VENOUS THROMBOSIS? If
so, update the verbatim term as
such. Otherwise please clarify
and edit the term. Thank you.
Mar-10-2021
19:08:36
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
1: Clo
sedDiscrepancy has been closed.
Mar-10-2021
16:40:16
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Ans
weredWe still do not have the studies
or the specific medical report to
be able to change the name of
the SAE in a medically
appropriate way. Thanks
Mar-09-2021
14:27:57
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Op
enedClarify PORTO-SPLENIC
THROMBOSIS as follows...The
term appears incomplete. Are
you reporting
PORTOSPLENOMESENTERIC
VENOUS THROMBOSIS? If
so, update the verbatim term as
such. Otherwise please clarify
and edit the term. Thank you
Mar-08-2021
08:55:28
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Rei
ssued:
Candi
dateThe term of the serious adverse
event will be modified
appropriately when we receive
reports from studies or a formal
medical report.
Mar-07-2021 ACV0PFEINFP6000  QueryIt is clarified that the term of the
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862115
Page 134 of 145
***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, Answered Queries
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
17:43:41
(UTC-03:00)
City of
Buenos Aires1: Ans
weredSAE was placed with the verbal
information obtained by the
subject. The term of the serious
adverse event will be modified
appropriately when we receive
reports from studies or a formal
medical report.
Mar-05-2021
05:45:04
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
1: Op
enedClarify PORTO-SPLENIC
THROMBOSIS as follows...The
term appears incomplete. Are
you reporting
PORTOSPLENOMESENTERIC
VENOUS THROMBOSIS? If
so, update the verbatim term as
such. Otherwise please clarify
and edit the term. Thank you.
Mar-04-2021
17:30:46
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Porto-
spleni
c thro
mbosi
sInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-23-2021 06:49:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed SDB updated
Mar-22-2021 15:38:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Reissued:Candidate Pending SDB update
Mar-22-2021 10:51:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Answered on 19MAR FU was sent
changing the start date.
Mar-22-2021 04:17:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2021243346 ,onset
date was recorded as
02Jan2021 in Safety
database however,
recorded as 03Mar2021
on AE CRF. Please
confirm correct Onset
Date. If safety update is
required, please submit a
follow-up SAE form.
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862116
Page 135 of 145
***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, Answered Queries
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Mar-20-2021 11:22:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Mar/3/2021 10:00New Information
Mar-04-2021 17:30:46
(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-04-2021 17:30:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-04-2021 17:30:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-08-2021 02:41:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-04-2021 17:30:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Porto-splenic
thrombosis: Response
to "Is the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Mar-04-2021 17:30:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with con
genital anomaly or birth defect?
NO
Did this serious event result in death?
NOInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862117
Page 136 of 145
***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, Answered Queries
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Did this serious event require or prolon
g hospitalization?
YES
Did this serious event result in persisten
t or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious even
t
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-04-2021 17:30:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-29-2021 12:05:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Mar-29-2021 12:05:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
Well-differentiated multifocal ne
uroendocrine tumor of the stoma
chNew Information
Mar-27-2021 14:49:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened Clinical - Other reason
for event is
UNKNOWN; please
clarify if any
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862118
Page 137 of 145
***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, Answered Queries
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
relationship to
neuroendocrine tumor
Mar-04-2021 17:30:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-04-2021 17:30:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-04-2021 17:30:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-04-2021 17:30:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-29-2021 10:29:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered On 25MAR, FU was sent with this
information: Status as
recovering/resolving.
Mar-29-2021 03:16:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2021243346,outcome
was reported as NOT
RECOVERED/NOT RESOLVED to
Safety DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862119
Page 138 of 145
***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, Answered Queries
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
form
Mar-26-2021 10:29:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGNew Information
Mar-04-2021 17:30:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-04-2021 17:30:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-08-2021 02:41:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2021243346Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862120
Page 139 of 145
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Mar-20-2021 11:24:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-20-2021 11:24:17
(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
Mar-20-2021 11:24:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Well-differentiated multifocal neuroendo
crine tumor of the stomachInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-20-2021 11:24:17
(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-20-2021 11:24:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-20-2021 11:24:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862121
Page 140 of 145
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
Mar-23-2021 06:05:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 2: Closed Recorded in SDB
Mar-22-2021 15:39:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 2: Reissued:Candidate Pending SDB update
Mar-22-2021 10:53:36
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 2: Answered SAE inicial form was
sent on 19MAR.
Mar-22-2021 06:28:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 2: Opened SAE RECON:
Well-differentiated
multifocal
neuroendocrine tumor of
the stomach 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
Mar-22-2021 06:27:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Deleted not in SDB YET
Mar-20-2021 11:24:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Well-differentiated
multifocal
neuroendocrine tumor of
the stomach: Response
to "Is the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Mar-20-2021 11:24:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with co
ngenital anomaly or birth defect?
NO
Did this serious event result in death?Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862122
Page 141 of 145
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
NO
Did this serious event require or prolon
g hospitalization?
YES
Did this serious event result in persiste
nt or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious even
t
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-20-2021 11:24:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-20-2021 11:24:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), this
event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-20-2021 11:24:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862123
Page 142 of 145
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Subject No: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-20-2021 11:24:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-20-2021 11:24:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-20-2021 11:24:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-20-2021 11:24:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-23-2021 06:04:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2021313526Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862124
Page 143 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-13-2021 12:52:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Jan/12/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-13-2021 12:52:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Martina
DavalliData Entry:
ASSESS ELIGIBILITY FOR ADDITIO
NAL VACCINATIONInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862125
Page 144 of 145
***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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-09-2020 22:03:15
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-16-2020 13:56:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-16-2020 13:50:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-09-2020 22:03:15
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/6/2020Initial Entry
Aug-16-2020 13:56:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/16/2020Initial Entry
Aug-16-2020 13:50:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/16/2020Initial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862126
Page 145 of 145
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12311510 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020 16:36:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Fernando
PolackData Entry:
Click Here to EnableInitial Entry
090177e196ae2f0d\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862127