Document text
Page 1 of 173
***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: 12311926 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
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865445
Page 2 of 173
***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: 12311926 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/18/2020
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865446
Page 3 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12311926]
2.Birth Date: /1988
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865447
Page 4 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/18/2020
2.Erroneous Visit
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865448
Page 5 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 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
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865449
Page 6 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 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
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865450
Page 7 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or systemic
corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
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
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865451
Page 8 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865452
Page 9 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
Medical History Details
1.Line/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865453
Page 10 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/18/2020
2.Weight: [77.0]
3.Unit: kg
4.Height: [174.0]
5.Unit: cm
6.Body Mass Index: [25.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865454
Page 11 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/18/2020
2.Randomization Number: [54038]
3.Randomization Group: [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865455
Page 12 of 173
***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: 12311926 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/18/2020
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 [BPHN2N]
5.bSample ID [BPHN2R]
5.cSample ID [BPHN2S]
5.dSample ID [BHWT4D]
5.eSample ID [BHWT4B]
5 fSample ID [BHWT4C]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865456
Page 13 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865457
Page 14 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Applicable Comments
2.Treatment Name Not Applicable
[ ]Comments
3.Formulation: Not Applicable Comments
4.Dose Date Time: Not Applicable
//Comments
5.Anatomical Location: Not Applicable Comments
6.Body Side: Not Applicable Comments
7.Route: Not Applicable Comments
8.Actual Dose: Not Applicable
[ ]Comments
9.Unit: Not Applicable Comments
10.Timeframe Subject Was Observed Not Applicable Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Applicable Comments
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865458
Page 15 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNot Done Comments
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865459
Page 16 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865460
Page 17 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L 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: 12311926 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:
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865461
Page 18 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L 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: 12311926 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 [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865462
Page 19 of 173
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L 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: 12311926 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?
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865463
Page 20 of 173
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865464
Page 21 of 173
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_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: 12311926 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 [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865465
Page 22 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865466
Page 23 of 173
***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: 12311926 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 [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865467
Page 24 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865468
Page 25 of 173
***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: 12311926 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 [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865469
Page 26 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865470
Page 27 of 173
***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: 12311926 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 [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865471
Page 28 of 173
***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: 12311926 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:
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865472
Page 29 of 173
***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: 12311926 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: [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865473
Page 30 of 173
***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: 12311926 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 [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865474
Page 31 of 173
***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: 12311926 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 [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865475
Page 32 of 173
***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: 12311926 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?
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865476
Page 33 of 173
***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: 12311926 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:
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865477
Page 34 of 173
***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: 12311926 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:
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865478
Page 35 of 173
***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: 12311926 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 [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865479
Page 36 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865480
Page 37 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865481
Page 38 of 173
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Not Applicable
//Comments
2.Phase of Disposition: Not Applicable Comments
3.Status: Not Applicable Comments
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865482
Page 39 of 173
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Aug/18/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865483
Page 40 of 173
***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: 12311926 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:
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865484
Page 41 of 173
***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: 12311926 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 [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865485
Page 42 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865486
Page 43 of 173
***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: 12311926 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:
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865487
Page 44 of 173
***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: 12311926 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?
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865488
Page 45 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865489
Page 46 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865490
Page 47 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865491
Page 48 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865492
Page 49 of 173
***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: 12311926 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 [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865493
Page 50 of 173
***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: 12311926 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 [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865494
Page 51 of 173
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - 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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865495
Page 52 of 173
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865496
Page 53 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#CategoryAE Identifie
rAdverse Even
tStart DateIs the Adverse Event Still Ongoi
ngForm Instance
1.ADVERSE EVEN
T 1 Syncope Aug/18/2020 10:2
5 NO
End Date Time:
Aug/18/2020 13:30
Repeating Pages
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865497
Page 54 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 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)[Syncope]
4.Start Date Time: Aug/18/2020 10:25
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/18/2020 13:30
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Post blood extraction]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865498
Page 55 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865499
Page 56 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865500
Page 57 of 173
***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: 12311926 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[ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865501
Page 58 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
1. Repeating
Pages
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865502
Page 59 of 173
***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: 12311926 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: //
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865503
Page 60 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865504
Page 61 of 173
***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: 12311926 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?
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865505
Page 62 of 173
***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: 12311926 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
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865506
Page 63 of 173
***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: 12311926 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?
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865507
Page 64 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865508
Page 65 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865509
Page 66 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865510
Page 67 of 173
***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: 12311926 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?
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865511
Page 68 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865512
Page 69 of 173
***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: 12311926 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: [ ]
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865513
Page 70 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Aug/18/2020
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865514
Page 71 of 173
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 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
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865515
Page 72 of 173
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Santiago
Corradetti Approved Nov-08-2020 16:35:36 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, SantiagoCorradetti, 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.
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865516
Page 73 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormAug-21-2020 12:39:24 (UTC-03:00) City of
Buenos Aires
FormAug-21-2020 12:33:13 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865517
Page 74 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormOct-03-2020 08:55:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865518
Page 75 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Oct-03-2020 08:55:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865519
Page 76 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2Oct-03-2020 08:55:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865520
Page 77 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
3Oct-03-2020 08:55:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865521
Page 78 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
4Oct-03-2020 08:55:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865522
Page 79 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormOct-03-2020 08:55:59 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865523
Page 80 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Oct-03-2020 08:55:59 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865524
Page 81 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2Oct-03-2020 08:55:59 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865525
Page 82 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
3Oct-03-2020 08:55:59 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865526
Page 83 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
4Oct-03-2020 08:55:59 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865527
Page 84 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
5Oct-03-2020 08:55:59 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865528
Page 85 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
6Oct-03-2020 08:55:59 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865529
Page 86 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
7Oct-03-2020 08:55:59 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865530
Page 87 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
8Oct-03-2020 08:55:59 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865531
Page 88 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
9Oct-03-2020 08:55:59 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865532
Page 89 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
10Oct-03-2020 08:55:59 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865533
Page 90 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
11Oct-03-2020 08:55:59 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865534
Page 91 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - Comments
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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormOct-07-2020 13:46:48 (UTC-03:00) City of Buenos
AiresNot Done
FormOct-03-2020 08:56:13 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865535
Page 92 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - Comments
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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Oct-07-2020 13:46:48 (UTC-03:00) City of Buenos
AiresNot Done
1Oct-03-2020 08:56:13 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865536
Page 93 of 173
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - Comments
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormNov-05-2020 15:04:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865537
Page 94 of 173
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Nov-05-2020 15:04:28 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865538
Page 95 of 173
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2Nov-05-2020 15:04:28 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865539
Page 96 of 173
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
3Nov-05-2020 15:04:28 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865540
Page 97 of 173
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
4Nov-05-2020 15:04:28 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865541
Page 98 of 173
***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, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Santiago
Corradetti Approved Nov-08-2020 16:35:36 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, SantiagoCorradetti, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-07-2020 13:17:13 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-06-2020 13:37:00 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-05-2020 15:03:52 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-02-2020 14:41:21 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865542
Page 99 of 173
***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, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865543
Page 100 of 173
***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: 12311926 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-21-2020 13:04:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
30 JUN 2020Initial Entry
Aug-21-2020 12:48:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:31:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-21-2020 13:04:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
STAGE 3 COHORTSInitial Entry
Aug-21-2020 12:48:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:31:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865544
Page 101 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-21-2020 13:04:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/18/2020Initial Entry
Aug-21-2020 12:50:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/18/2020Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865545
Page 102 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-18-2020 10:11:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12311926Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-21-2020 13:53:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-21-2020 12:32:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Changed data per
query
Aug-21-2020 09:15:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Balaji Prabu R Query 1: Opened Please complete
cohort selection and
Informed consent
CRF.
Aug-18-2020 10:11:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1988Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-21-2020 13:05:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
MALEInitial Entry
Aug-21-2020 12:49:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865546
Page 103 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-21-2020 13:05:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
HISPANIC OR LATINO(A) OR OF
SPANISH ORIGINInitial Entry
Aug-21-2020 12:49:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-21-2020 13:05:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
WHITEInitial Entry
Aug-21-2020 12:49:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865547
Page 104 of 173
***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: 12311926 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-04-2020 08:21:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-03-2020 08:57:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Subject is
discontinued since
aug/18. forms updated
accordingly.
Oct-01-2020 14:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened Please respond to this
query once action has
been taken.
Oct-01-2020 12:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The subject expresses
his desire to receive
the vaccine, was told
that if there are
appointments
available, he will be
contacted again Thank
you
Sep-28-2020 12:15:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened Please consider
entering Not
Applicable for these
forms.
Sep-28-2020 08:24:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered This subject was
discontinued before
finishing the visit
process.
Sep-28-2020 06:01:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM Query: Kindly
review and complete
‘Vaccination and
Nasal Swab form and
Reactogenecity' at this
visit. Thank you.
Aug-21-2020 12:32:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (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) (6)
(b) (4)
FDA-CBER-2021-5683-0865548
Page 105 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Inclus
ion Nu
mber:1
Criter
ion De
scripti
on:Male or female participants
between the ages of 18 and
55 years, inclusive, 65 and
85 years, inclusive, or 18 a
nd 85 years, inclusive, at ra
ndomization (dependent up
on study stage)
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
Aug-21-2020 12:39:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion Nu
mber:1
Criter
ion De
scripti
on:Male or female participants
between the ages of 18 and
55 years, inclusive, 65 and
85 years, inclusive, or 18 a
nd 85 years, inclusive, at ra
ndomization (dependent up
on study stage)
Criter
ion me
t?:
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Transcription Error
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865549
Page 106 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion Nu
mber:1
Criter
ion De
scripti
on:Male or female participants
between the ages of 18 and
55 years, inclusive, 65 and
85 years, inclusive, or 18 a
nd 85 years, inclusive, at ra
ndomization (dependent up
on study stage)
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Male or female participants between t
he ages of 18 and 55 years, inclusive,
65 and 85 years, inclusive, or 18 and 8
5 years, inclusive, at randomization (d
ependent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
YESInitial Entry
Aug-21-2020 12:39:59
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry: Transcription Error
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865550
Page 107 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willin
g and able to comply with
all scheduled visits, vaccin
ation plan, laboratory tests
, lifestyle considerations, a
nd other study procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN02A00Initial Entry
Aug-21-2020 12:40:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willin
g and able to comply with
all scheduled visits, vaccin
ation plan, laboratory tests
, lifestyle considerations, a
nd other study proceduresTranscription Error
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865551
Page 108 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on met
?:
Criteri
on ID:
(For Pf
izer us
e only)
:IN02A00
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willin
g and able to comply with
all scheduled visits, vaccin
ation plan, laboratory tests
, lifestyle considerations, a
nd other study procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN02A00Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865552
Page 109 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Inclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are willing and able t
o comply with all scheduled visits, va
ccination plan, laboratory tests, lifesty
le considerations, and other study proc
eduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
YESInitial Entry
Aug-21-2020 12:40:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865553
Page 110 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Healthy participants who a
re determined by medical
history, physical examinati
on, and clinical judgment
of the investigator to be eli
gible for inclusion in the st
udy
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
Aug-21-2020 12:40:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who a
re determined by medical
history, physical examinati
on, and clinical judgment
of the investigator to be eli
gible for inclusion in the st
udy
Criteri
on met
?:
Criteri
on ID:
(For P
fizer u
se only
):IN03A00Transcription Error
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865554
Page 111 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Healthy participants who a
re determined by medical
history, physical examinati
on, and clinical judgment
of the investigator to be eli
gible for inclusion in the st
udy
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865555
Page 112 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Inclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants who are determin
ed by medical history, physical exami
nation, and clinical judgment of the in
vestigator to be eligible for inclusion i
n the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
YESInitial Entry
Aug-21-2020 12:40:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865556
Page 113 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Capable of giving personal
signed informed consent,
which includes complianc
e with the requirements an
d restrictions listed in the I
CD and in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN04A00
Aug-21-2020 12:40:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4
Criteri
on Des
criptio
n:Capable of giving personal
signed informed consent,
which includes complianc
e with the requirements an
d restrictions listed in the I
CD and in this protocol
Criteri
on met
?:
Criteri
on ID:
(For Pf
izer us
e only)
:IN04A00Transcription Error
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4
Criteri
on Des
criptio
n:Capable of giving personal
signed informed consent,
which includes complianc
e with the requirements an
d restrictions listed in the I
CD and in this protocolInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865557
Page 114 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN04A00
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865558
Page 115 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Inclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal signed inf
ormed consent, which includes compli
ance with the requirements and restric
tions listed in the ICD and in this prot
ocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
YESInitial Entry
Aug-21-2020 12:40:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865559
Page 116 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Other medical or psychiatr
ic condition incl. recent (w
ithin past year) or active su
icidal ideation/behavior/la
b abnormality that may inc
rease the risk of study parti
cipation
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00
Aug-21-2020 12:44:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatr
ic condition incl. recent (w
ithin past year) or active su
icidal ideation/behavior/la
b abnormality that may inc
rease the risk of study parti
cipation
Criteri
on met
?:
Criteri
on ID:
(For P
fizer u
se only
):EX01A00Transcription Error
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865560
Page 117 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Other medical or psychiatr
ic condition incl. recent (w
ithin past year) or active su
icidal ideation/behavior/la
b abnormality that may inc
rease the risk of study parti
cipation
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatric condition
incl. recent (within past year) or active
suicidal ideation/behavior/lab abnorm
ality that may increase the risk of stud
y participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
Aug-21-2020 12:44:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865561
Page 118 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with hu
man immunodeficiency
virus (HIV), hepatitis C
virus (HCV), or hepatitis
B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX02A00Initial Entry
Aug-21-2020 12:45:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with hu
man immunodeficiency
virus (HIV), hepatitis C
virus (HCV), or hepatitis
B virus (HBV)
Criterio
n met?:
Criterio
n ID: (F
or Pfizer
use only
):EX02A00Transcription Error
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865562
Page 119 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with hu
man immunodeficiency
virus (HIV), hepatitis C
virus (HCV), or hepatitis
B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX02A00Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865563
Page 120 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.b Exclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with human immuno
deficiency virus (HIV), hepatitis C vir
us (HCV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
Aug-21-2020 12:45:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Exclusi
on Nu
mber:3Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865564
Page 121 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:History of severe adverse r
eaction associated with a v
accine and/or severe allerg
ic reaction (eg, anaphylaxi
s) to any component of the
study intervention(s)
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX03A00
Aug-21-2020 12:45:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse r
eaction associated with a v
accine and/or severe allerg
ic reaction (eg, anaphylaxi
s) to any component of the
study intervention(s)
Criteri
on met
?:
Criteri
on ID:
(For Pf
izer us
e only)
:EX03A00Transcription Error
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse r
eaction associated with a v
accine and/or severe allerg
ic reaction (eg, anaphylaxi
s) to any component of the
study intervention(s)Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865565
Page 122 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX03A00
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865566
Page 123 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Exclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adverse reaction ass
ociated with a vaccine and/or severe al
lergic reaction (eg, anaphylaxis) to an
y component of the study intervention
(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
Aug-21-2020 12:45:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Exclusion Nu
mber:4Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865567
Page 124 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion De
scription:Receipt of medicati
ons intended to prev
ent COVID-19
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX04A00
Aug-21-2020 12:45:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:4
Criterion De
scription:Receipt of medicati
ons intended to prev
ent COVID-19
Criterion me
t?:
Criterion ID:
(For Pfizer u
se only):EX04A00Transcription Error
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:4
Criterion De
scription:Receipt of medicati
ons intended to prev
ent COVID-19
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX04A00Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865568
Page 125 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.d Exclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of medications intended to pre
vent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
Aug-21-2020 12:45:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Exclusi
on Nu
mber:8Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865569
Page 126 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Immunocompromised indi
viduals with known or sus
pected immunodeficiency,
as determined by history a
nd/or laboratory/physical
examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX08A00
Aug-21-2020 12:46:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Des
criptio
n:Immunocompromised indi
viduals with known or sus
pected immunodeficiency,
as determined by history a
nd/or laboratory/physical
examination
Criteri
on met
?:
Criteri
on ID:
(For Pf
izer use
only):EX08A00Transcription Error
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Des
criptio
n:Immunocompromised indi
viduals with known or sus
pected immunodeficiency,
as determined by history a
nd/or laboratory/physical
examination
Criteri
on met
?:NOInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865570
Page 127 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on ID:
(For Pf
izer use
only):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised individuals wit
h known or suspected immunodeficien
cy, as determined by history and/or la
boratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
Aug-21-2020 12:46:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865571
Page 128 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Exclusi
on Nu
mber:10
Criteri
on Des
criptio
n:Bleeding diathesis or cond
ition associated with prolo
nged bleeding that would,
in the opinion of the invest
igator, contraindicate intra
muscular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX10A00Initial Entry
Aug-21-2020 12:46:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:10
Criteri
on Des
criptio
n:Bleeding diathesis or cond
ition associated with prolo
nged bleeding that would,
in the opinion of the invest
igator, contraindicate intra
muscular injection
Criteri
on met
?:
Criteri
on ID:
(For Pf
izer us
e only):EX10A00Transcription Error
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:10
Criteri
on Des
criptio
n:Bleeding diathesis or cond
ition associated with prolo
nged bleeding that would,
in the opinion of the invest
igator, contraindicate intra
muscular injectionInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865572
Page 129 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition associ
ated with prolonged bleeding that wou
ld, in the opinion of the investigator, c
ontraindicate intramuscular injectionInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865573
Page 130 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.f Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
Aug-21-2020 12:46:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Exclusion Num
ber:11
Criterion Desc
ription:Women who are p
regnant or breastf
eeding
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX11A00Initial Entry
Aug-21-2020 12:46:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Num
ber:11
Criterion Desc
ription:Women who are p
regnant or breastf
eeding
Criterion met?
:Transcription Error
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865574
Page 131 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion ID: (
For Pfizer use
only):EX11A00
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Num
ber:11
Criterion Desc
ription:Women who are p
regnant or breastf
eeding
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX11A00Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865575
Page 132 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.g Exclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are pregnant or breastfee
dingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
Aug-21-2020 12:46:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinatio
n with any coronav
irus vaccineInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865576
Page 133 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX12A00
Aug-21-2020 12:46:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinatio
n with any coronav
irus vaccine
Criterion met
?:
Criterion ID:
(For Pfizer us
e only):EX12A00Transcription Error
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinatio
n with any coronav
irus vaccine
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX12A00Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865577
Page 134 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.h Exclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with any corona
virus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
Aug-21-2020 12:46:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Exclusio
n Numbe
r:13Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865578
Page 135 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion
Descripti
on:Subjects who receive im
munosuppressive therap
y, such as cytotoxic age
nts or systemic corticost
eroids
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX13A01
Aug-21-2020 12:47:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:13
Criterion
Descripti
on:Subjects who receive im
munosuppressive therap
y, such as cytotoxic age
nts or systemic corticost
eroids
Criterion
met?:
Criterion
ID: (For
Pfizer us
e only):EX13A01Transcription Error
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:13
Criterion
Descripti
on:Subjects who receive im
munosuppressive therap
y, such as cytotoxic age
nts or systemic corticost
eroids
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX13A01Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865579
Page 136 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.i Exclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immunosuppres
sive therapy, such as cytotoxic agents
or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
Aug-21-2020 12:47:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Exclusi
on Nu
mber:15Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865580
Page 137 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Receipt of blood/plasma p
roducts or immunoglobuli
n, from 60 days before stu
dy intervention administra
tion or planned receipt thr
oughout the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX14A01
Aug-21-2020 12:47:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma p
roducts or immunoglobuli
n, from 60 days before stu
dy intervention administra
tion or planned receipt thr
oughout the study
Criteri
on met
?:
Criteri
on ID:
(For Pf
izer us
e only):EX14A01Transcription Error
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma p
roducts or immunoglobuli
n, from 60 days before stu
dy intervention administra
tion or planned receipt thr
oughout the study
Criteri
on met
?:NOInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865581
Page 138 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on ID:
(For Pf
izer us
e only):EX14A01
2.j Exclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products or i
mmunoglobulin, from 60 days before
study intervention administration or pl
anned receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
Aug-21-2020 12:47:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
2.k
Date Location User Value Reason
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865582
Page 139 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Exclusi
on Num
ber:16
Criterio
n Descri
ption:Participation in other stud
ies involving study interv
ention within 28 days pri
or to study entry and/or d
uring study participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01Initial Entry
Aug-21-2020 12:47:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:16
Criterio
n Descri
ption:Participation in other stud
ies involving study interv
ention within 28 days pri
or to study entry and/or d
uring study participation
Criterio
n met?:
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01Transcription Error
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:16
Criterio
n Descri
ption:Participation in other stud
ies involving study interv
ention within 28 days pri
or to study entry and/or d
uring study participation
Criterio
n met?:NOInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865583
Page 140 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01
2.k Exclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other studies involvin
g study intervention within 28 days pri
or to study entry and/or during study p
articipationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
Aug-21-2020 12:47:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865584
Page 141 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Exclusion
Number:17
Criterion
Descripti
on:Previous participation in
other studies involving s
tudy intervention contai
ning lipid nanoparticles
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX16A01Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865585
Page 142 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.l
Date Location User Value Reason
Aug-21-2020 12:47:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:17
Criterion
Descripti
on:Previous participation in
other studies involving st
udy intervention containi
ng lipid nanoparticles
Criterion
met?:
Criterion
ID: (For
Pfizer use
only):EX16A01Transcription Error
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:17
Criterion
Descripti
on:Previous participation in
other studies involving st
udy intervention containi
ng lipid nanoparticles
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX16A01Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865586
Page 143 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.l Exclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participation in other studies
involving study intervention containin
g lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-21-2020 13:05:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
Aug-21-2020 12:47:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:22Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0865587
Page 144 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Investigator site staff or Pfiz
er employees directly involv
ed in the conduct of the stud
y, site staff otherwise superv
ised by the investigator, and
their respective family mem
bers
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX21A01
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865588
Page 145 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Exclusion Number:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer emplo
yees directly involved in the conduct
of the study, site staff otherwise super
vised by the investigator, and their res
pective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-21-2020 12:32:53
(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-21-2020 12:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865589
Page 146 of 173
***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: 12311926 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-21-2020 12:33:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-21-2020 12:33:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-21-2020 13:05:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
COMPLETEDInitial Entry
Aug-21-2020 12:39:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:33:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865590
Page 147 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Aug-21-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Aug/18/2020Initial Entry
Aug-21-2020 12:39:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:33:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-21-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
77.0Initial Entry
Aug-21-2020 12:38:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:33:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
77.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-21-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
kgInitial Entry
Aug-21-2020 12:38:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-21-2020 12:38:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:38:04
(UTC-03:00) City ofACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened kg is selected for
weight unit, then cm
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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)
(b) (4)
FDA-CBER-2021-5683-0865591
Page 148 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires is expected to be
selected for Height
unit. Please check and
update data as
appropriate.
Aug-21-2020 12:33:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-21-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
174.0Initial Entry
Aug-21-2020 12:38:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:33:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
174.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-21-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
cmInitial Entry
Aug-21-2020 12:38:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:33:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-21-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.4Initial Entry
Aug-21-2020 12:38:56
(UTC-03:00) City ofACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865592
Page 149 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
Aug-21-2020 12:38:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Aug-21-2020 12:38:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Aug-21-2020 12:38:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Aug-21-2020 12:33:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.4Initial Entry
7.a
Date Location User Value Reason
Aug-21-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Record Identifier:: 1
Temperature: 36.3
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
Aug-21-2020 12:37:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature:
Temperature Unit:
Temperature Location::Transcription Error
Aug-21-2020 12:33:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.3
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-21-2020 12:33:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865593
Page 150 of 173
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
7.a Temperature:
Date Location User Value Reason
Aug-21-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
36.3Initial Entry
Aug-21-2020 12:37:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:33:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-21-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
CInitial Entry
Aug-21-2020 12:37:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:33:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-21-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
ORAL CAVITYInitial Entry
Aug-21-2020 12:37:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:33:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (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)
(b) (4)
FDA-CBER-2021-5683-0865594
Page 151 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-21-2020 13:07:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Aug/18/2020Initial Entry
Aug-21-2020 12:37:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 12:34:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020 01:27:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed As per site response
Aug-24-2020 21:32:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Query 1: Answered Subject was
randomized and after
blood sample
collection decided not
receive the study
intervention, based on
medical record.Thank
you
Aug-24-2020 09:18:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened PDQ: Subject has
been randomized,
however, has not been
Vaccinated. Please
reconcile and update
accordingly, else
clarify.
Aug-21-2020 13:07:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
54038Initial Entry
Aug-21-2020 12:37:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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)
(b) (4)
FDA-CBER-2021-5683-0865595
Page 152 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-21-2020 12:34:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
54038Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865596
Page 153 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 13:07:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 13:07:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-22-2020 08:51:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-21-2020 14:05:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-21-2020 13:07:54
(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-21-2020 13:07:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865597
Page 154 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-22-2020 08:51:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BPHN2NInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 08:51:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BPHN2NInitial Entry
5.b
Date Location User Value Reason
Aug-22-2020 08:51:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BPHN2RInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-22-2020 08:51:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BPHN2RInitial Entry
5.c
Date Location User Value Reason
Aug-22-2020 08:51:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BPHN2SInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-22-2020 08:51:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BPHN2SInitial Entry
5.d
Date Location User Value Reason
Sep-01-2020 15:43:25
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Sample ID: BHWT4DInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0865598
Page 155 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
5.d Sample ID
Date Location User Value Reason
Sep-01-2020 15:43:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHWT4DInitial Entry
5.e
Date Location User Value Reason
Sep-01-2020 15:44:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHWT4BInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-01-2020 15:44:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHWT4BInitial Entry
5.f
Date Location User Value Reason
Sep-01-2020 15:44:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHWT4CInitial Entry
5.f Sample ID
Date Location User Value Reason
Sep-01-2020 15:44:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHWT4CInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0865599
Page 156 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-03-2020 08:55:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-03-2020 08:55:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020
08:10:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: C
losedClosing as subject
discontinued
Oct-05-2020
08:31:30
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Romina Barrera Query 1: A
nsweredThe volunteer presents
complications to the
procedure. For the
moment he did not
introduce himself
again.
Oct-05-2020
07:35:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: O
penedDMW4879678;Sample
Collected is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Oct-03-2020
08:55:38
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entr
y:
Not Applic
ableInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865600
Page 157 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-03-2020 08:55:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865601
Page 158 of 173
***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: 12311926 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
Oct-03-2020 08:55:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-03-2020 08:55:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-03-2020 08:55:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Oct-30-2020
12:54:17
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Oct-29-2020
10:28:01
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: Ans
weredSubject was discontinued
Oct-28-2020
16:37:02
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5207835;Randomization
number is recorded and the
final disposition date is
present on the Disposition -
Follow-up eCRF, but there is
no dosing date present on the
Treatment eCRF. Please
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(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-2021-5683-0865602
Page 159 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
review and update as
appropriate.
Oct-03-2020
08:55:59
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-03-2020 08:55:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-03-2020 08:55:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Route:
Date Location User Value Reason
Oct-03-2020 08:55:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
8. Actual Dose:
Date Location User Value Reason
Oct-03-2020 08:55:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Unit:
Date Location User Value Reason
Oct-03-2020 08:55:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
10. Timeframe Subject Was Observed
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0865603
Page 160 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Oct-03-2020 08:55:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-03-2020 08:55:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865604
Page 161 of 173
***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: 12311926 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
Oct-07-2020
16:44:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: Cl
osedAuto closed by
Validation Check:
VC_TRIG001_02
Oct-07-2020
13:47:06
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: An
sweredChanged data per
query
Oct-07-2020
13:46:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry
:
Not DoneInitial Entry
Oct-05-2020
05:14:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: Op
enedDMW4879674;Select
appropriate response -
Reactogenicity diary
collection is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or
clarify
Oct-03-2020
08:56:13
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry
:
Not Applica
bleInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865605
Page 162 of 173
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 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
Nov-05-2020 17:50:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-05-2020 15:04:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-05-2020 15:03:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-05-2020 15:03:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Nov-05-2020 14:07:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Balaji Prabu R Query 1: Opened In case subject
randomized and did
not receive the
vaccination, this CRF
is not expected to be
completed. Hence
please remove all data
entered and add form
level comment as
NOT APPLICABLE.
Else clarify.
Aug-21-2020 13:09:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Aug/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-05-2020 15:04:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Nov-05-2020 15:03:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Aug-21-2020 13:09:22 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865606
Page 163 of 173
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos Aires(autocalc) VACCINATION
3. Status:
Date Location User Value Reason
Nov-05-2020 15:04:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-05-2020 15:04:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-21-2020 13:09:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Aug-21-2020 13:09:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
ADVERSE EVENTInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-05-2020 15:04:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865607
Page 164 of 173
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-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: 12311926 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-28-2020 10:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-28-2020 10:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Oct-28-2020 10:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ADVERSE EVENTInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0865608
Page 165 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Form Created
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865609
Page 166 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
SyncopeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Aug/18/2020 10:25Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Aug-21-2020 13:22:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NO
End Date Time:
Aug/18/2020 13:30Transcription Error
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865610
Page 167 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
2Initial 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
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOT RELATED
If Not Related to study treatment(s)
, this event is due to:
OTHER
If Other, specify:
Post blood extractionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-07-2020 17:00:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865611
Page 168 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Nov-07-2020 13:17:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Nov-07-2020 13:17:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLETranscription Error
Nov-07-2020 11:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Balaji Prabu R Query 2: Opened Latest Action Taken
with Study Treatment
question is answered
as DRUG
WITHDRAWN,
however subject has
not received
vaccination 1 or 2.
Please verify and
update as NOT
APPLICABLE if
appropriate. Else
clarify.
Sep-09-2020 10:07:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Marjorie
BuonannoQuery 1: Closed Response satisfies
query
Sep-08-2020 17:14:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Sep-08-2020 17:14:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNNew Information
Sep-02-2020 12:44:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Marjorie
BuonannoQuery 1: Opened Clin Query:
Treatment Disposition
page states subject
discontinued from
Treatment due to
Adverse Event. As
per study guidelines,
Action taken with
Study treatment on
AE page must state
DRUG
WITHDRAWN.
Please correct
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865612
Page 169 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
11. Was a Concomitant Medication given?
Date Location User Value Reason
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Aug-21-2020 13:22:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Syncope: Response
to "What was the outcome
of this adverse event?" is
RECOVERED/RESOLVED
but End Date/Time is
missing.
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-29-2020 08:13:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Data updated
Oct-28-2020 10:39:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered Original value is
correct
Oct-27-2020 14:49:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Erica Weaver Query 2: Opened this question is YES,
however, FUP
disposition is not
completed. If subject
is discontinued from
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865613
Page 170 of 173
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
study, please enter
FUP disposition. If
subject is continuing,
please update to NO.
Aug-24-2020 03:50:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Unscheduled has
status ADVERSE
EVENT
Aug-21-2020 16:22:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Query 1: Answered DISPOSITION -
TREATMENT –
Unscheduled has
status ADVERSE
EVENT. Please advise
how to proceed.
Thank you
Aug-21-2020 14:05:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Did the adverse event
cause the subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Did the adverse event
cause the subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Aug-21-2020 13:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
YESInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0865614
Page 171 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-05-2020 15:04:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Oct-28-2020 10:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-21-2020 13:09:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-21-2020 13:07:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-21-2020 13:05:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
Aug-21-2020 12:39:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Aug-21-2020 12:37:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDTranscription Error
Aug-21-2020 12:34:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-21-2020 12:33:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-05-2020 15:04:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Transcription Error
Nov-05-2020 15:03:52
(UTC-03:00) City ofACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Transcription Error
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865615
Page 172 of 173
***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: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
Oct-28-2020 10:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
Aug-21-2020 13:09:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
Aug-21-2020 13:07:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
Aug-21-2020 13:05:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
Aug-21-2020 12:39:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Aug-21-2020 12:37:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Transcription Error
Aug-21-2020 12:34:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
Aug-21-2020 12:33:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0865616
Page 173 of 173
***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, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311926 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-02-2020 14:41:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2ef1\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0865617