125742 S1 M5 CRF c4591001 1231 12311409

Document text

Page 1 of 193
***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: 12311409 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
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861627
Page 2 of 193
***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: 12311409 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/15/2020
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861628
Page 3 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12311409]
2.Birth Date: 1982
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861629
Page 4 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/15/2020
2.Erroneous Visit
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861630
Page 5 of 193
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 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
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861631
Page 6 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 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
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861632
Page 7 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 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
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861633
Page 8 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861634
Page 9 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861635
Page 10 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/15/2020
2.Weight: [54.25]
3.Unit: kg
4.Height: [188.0]
5.Unit: cm
6.Body Mass Index: [15.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861636
Page 11 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/15/2020
2.Randomization Number: [51472]
3.Randomization Group: [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861637
Page 12 of 193
***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: 12311409 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/15/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM83YX]
5.bSample ID [BM83YY]
5.cSample ID [BM83YZ]
5.dSample ID [BLCVPZ]
5.eSample ID [BLCVR0]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861638
Page 13 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[After blood extraction with complications, the volunteer decide not to continue with
the study so no swabbing and no other procedure was performed]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861639
Page 14 of 193
***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: 12311409 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
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861640
Page 15 of 193
***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: 12311409 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 Applicable Comments
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861641
Page 16 of 193
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861642
Page 17 of 193
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Temperature: Not Done
[ ]Comments
Unit: Not Done Comments
Temperature Location: Not Done Comments
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861643
Page 18 of 193
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 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 Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861644
Page 19 of 193
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 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 Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861645
Page 20 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861646
Page 21 of 193
***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: 12311409 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 [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861647
Page 22 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861648
Page 23 of 193
***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: 12311409 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 [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861649
Page 24 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861650
Page 25 of 193
***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: 12311409 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 [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861651
Page 26 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861652
Page 27 of 193
***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: 12311409 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 [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861653
Page 28 of 193
***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: 12311409 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:
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861654
Page 29 of 193
***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: 12311409 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: [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861655
Page 30 of 193
***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: 12311409 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 [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861656
Page 31 of 193
***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: 12311409 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 [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861657
Page 32 of 193
***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: 12311409 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?
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861658
Page 33 of 193
***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: 12311409 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:
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861659
Page 34 of 193
***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: 12311409 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:
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861660
Page 35 of 193
***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: 12311409 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 [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861661
Page 36 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861662
Page 37 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861663
Page 38 of 193
***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: 12311409 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
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861664
Page 39 of 193
***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: 12311409 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/15/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861665
Page 40 of 193
***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: 12311409 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:
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861666
Page 41 of 193
***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: 12311409 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 [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861667
Page 42 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861668
Page 43 of 193
***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: 12311409 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:
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861669
Page 44 of 193
***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: 12311409 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?
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861670
Page 45 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861671
Page 46 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861672
Page 47 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861673
Page 48 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861674
Page 49 of 193
***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: 12311409 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 [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861675
Page 50 of 193
***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: 12311409 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 [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861676
Page 51 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861677
Page 52 of 193
***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: 12311409 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?
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861678
Page 53 of 193
***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: 12311409 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/15/2020 15:4
0 NO
End Date Time:
Aug/15/2020 15:41
 Repeating Pages
 2.ADVERSE EVEN
T 2  vomits  Aug/15/2020 15:3
0 NO
End Date Time:
Aug/15/2020 15:40
 Repeating Pages
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861679
Page 54 of 193
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 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/15/2020 15:40
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/15/2020 15:41
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 phlebotomy]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861680
Page 55 of 193
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
12.Was a Non-Drug Treatment given? YES
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[ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861681
Page 56 of 193
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[vomits]
4.Start Date Time: Aug/15/2020 15:30
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/15/2020 15:40
6.Toxicity Grade: 1
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 sincopal recovery]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861682
Page 57 of 193
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
12.Was a Non-Drug Treatment given? YES
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[ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861683
Page 58 of 193
***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: 12311409 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 Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861684
Page 59 of 193
***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: 12311409 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[ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861685
Page 60 of 193
***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: 12311409 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
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861686
Page 61 of 193
***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: 12311409 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: //
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861687
Page 62 of 193
***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: 12311409 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
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861688
Page 63 of 193
***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: 12311409 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?
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861689
Page 64 of 193
***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: 12311409 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
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861690
Page 65 of 193
***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: 12311409 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?
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861691
Page 66 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861692
Page 67 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861693
Page 68 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861694
Page 69 of 193
***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: 12311409 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?
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861695
Page 70 of 193
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861696
Page 71 of 193
***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: 12311409 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: [ ]
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861697
Page 72 of 193
***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: 12311409 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/15/2020
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861698
Page 73 of 193
***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: 12311409 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
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861699
Page 74 of 193
***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: 12311409 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
 Approved Nov-17-2020 20:22:57 (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.
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861700
Page 75 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormAug-21-2020 10:18:21 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861701
Page 76 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormSep-28-2020 19:45:08 (UTC-03:00) City of Buenos
AiresWithdrawal of consent from the volunteer both for
the study treatment, procedures and subsequent
follow-up. Thank you
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861702
Page 77 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Sep-28-2020 19:45:08 (UTC-03:00) City of Buenos
AiresWithdrawal of consent from the volunteer both for
the study treatment, procedures and subsequent
follow-up. Thank you
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861703
Page 78 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2Sep-28-2020 19:45:08 (UTC-03:00) City of Buenos
AiresWithdrawal of consent from the volunteer both for
the study treatment, procedures and subsequent
follow-up. Thank you
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861704
Page 79 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
3Sep-28-2020 19:45:08 (UTC-03:00) City of Buenos
AiresWithdrawal of consent from the volunteer both for
the study treatment, procedures and subsequent
follow-up. Thank you
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861705
Page 80 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
4Sep-28-2020 19:45:08 (UTC-03:00) City of Buenos
AiresWithdrawal of consent from the volunteer both for
the study treatment, procedures and subsequent
follow-up. Thank you
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861706
Page 81 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
5Sep-28-2020 19:45:08 (UTC-03:00) City of Buenos
AiresWithdrawal of consent from the volunteer both for
the study treatment, procedures and subsequent
follow-up. Thank you
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861707
Page 82 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
6Sep-28-2020 19:45:08 (UTC-03:00) City of Buenos
AiresWithdrawal of consent from the volunteer both for
the study treatment, procedures and subsequent
follow-up. Thank you
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861708
Page 83 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
7Sep-28-2020 19:45:08 (UTC-03:00) City of Buenos
AiresWithdrawal of consent from the volunteer both for
the study treatment, procedures and subsequent
follow-up. Thank you
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861709
Page 84 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
8Sep-28-2020 19:45:08 (UTC-03:00) City of Buenos
AiresWithdrawal of consent from the volunteer both for
the study treatment, procedures and subsequent
follow-up. Thank you
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861710
Page 85 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
9Sep-28-2020 19:45:08 (UTC-03:00) City of Buenos
AiresWithdrawal of consent from the volunteer both for
the study treatment, procedures and subsequent
follow-up. Thank you
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861711
Page 86 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
10Sep-28-2020 19:45:08 (UTC-03:00) City of Buenos
AiresWithdrawal of consent from the volunteer both for
the study treatment, procedures and subsequent
follow-up. Thank you
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861712
Page 87 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
11Sep-28-2020 19:45:08 (UTC-03:00) City of Buenos
AiresWithdrawal of consent from the volunteer both for
the study treatment, procedures and subsequent
follow-up. Thank you
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861713
Page 88 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormSep-28-2020 19:45:47 (UTC-03:00) City of Buenos
AiresWithdrawal of consent from the volunteer both for
the study treatment, procedures and subsequent
follow-up. Thank you
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861714
Page 89 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Sep-28-2020 19:45:47 (UTC-03:00) City of Buenos
AiresWithdrawal of consent from the volunteer both for
the study treatment, procedures and subsequent
follow-up. Thank you
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861715
Page 90 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormNov-07-2020 10:23:25 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861716
Page 91 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Nov-07-2020 10:23:25 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861717
Page 92 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2Nov-07-2020 10:23:25 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861718
Page 93 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormNov-07-2020 10:23:37 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861719
Page 94 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Nov-07-2020 10:23:37 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861720
Page 95 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2.aNov-07-2020 10:23:37 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861721
Page 96 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2.aNov-07-2020 10:23:37 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861722
Page 97 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2.aNov-07-2020 10:23:37 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861723
Page 98 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormNov-07-2020 10:23:50 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861724
Page 99 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Nov-07-2020 10:23:50 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861725
Page 100 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2Nov-07-2020 10:23:50 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861726
Page 101 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
3Nov-07-2020 10:23:50 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861727
Page 102 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
4Nov-07-2020 10:23:50 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861728
Page 103 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormNov-07-2020 10:24:03 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861729
Page 104 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Nov-07-2020 10:24:03 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861730
Page 105 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2Nov-07-2020 10:24:03 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861731
Page 106 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
3Nov-07-2020 10:24:03 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861732
Page 107 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
4Nov-07-2020 10:24:03 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861733
Page 108 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
5Nov-07-2020 10:24:03 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861734
Page 109 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
6Nov-07-2020 10:24:03 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861735
Page 110 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
7Nov-07-2020 10:24:03 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861736
Page 111 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
8Nov-07-2020 10:24:03 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861737
Page 112 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
9Nov-07-2020 10:24:03 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861738
Page 113 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
10Nov-07-2020 10:24:03 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861739
Page 114 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
11Nov-07-2020 10:24:03 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861740
Page 115 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormNov-07-2020 10:23:08 (UTC-03:00) City of
Buenos AiresNot Applicable
FormNov-07-2020 10:21:44 (UTC-03:00) City of
Buenos Aires
FormNov-05-2020 15:06:51 (UTC-03:00) City of
Buenos Aireschanged to not applicable as query requested
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861741
Page 116 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Nov-07-2020 10:23:08 (UTC-03:00) City of Buenos
AiresNot Applicable
1Nov-07-2020 10:21:44 (UTC-03:00) City of Buenos
Aires
1Nov-05-2020 15:06:51 (UTC-03:00) City of Buenos
Aireschanged to not applicable as query requested
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861742
Page 117 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2Nov-07-2020 10:23:08 (UTC-03:00) City of Buenos
AiresNot Applicable
2Nov-07-2020 10:21:44 (UTC-03:00) City of Buenos
Aires
2Nov-05-2020 15:06:51 (UTC-03:00) City of Buenos
Aireschanged to not applicable as query requested
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861743
Page 118 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
3Nov-07-2020 10:23:08 (UTC-03:00) City of Buenos
AiresNot Applicable
3Nov-07-2020 10:21:44 (UTC-03:00) City of Buenos
Aires
3Nov-05-2020 15:06:51 (UTC-03:00) City of Buenos
Aireschanged to not applicable as query requested
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861744
Page 119 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
4Nov-07-2020 10:23:08 (UTC-03:00) City of Buenos
AiresNot Applicable
4Nov-07-2020 10:21:44 (UTC-03:00) City of Buenos
Aires
4Nov-05-2020 15:06:51 (UTC-03:00) City of Buenos
Aireschanged to not applicable as query requested
Not Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861745
Page 120 of 193
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormNov-17-2020 19:07:30 (UTC-03:00) City of
Buenos AiresNot Applicable
FormNov-17-2020 19:06:29 (UTC-03:00) City of
Buenos AiresNot applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861746
Page 121 of 193
***Confidential***
Header Text: C4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Nov-17-2020 19:07:30 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861747
Page 122 of 193
***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: 12311409 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
 Approved Nov-17-2020 20:22:57 (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-17-2020 19:06:29 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando Polack  Approved Nov-17-2020 11:55:43 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-17-2020 10:12:45 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando Polack  Approved Nov-16-2020 11:12:16 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861748
Page 123 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-12-2020 10:59:50 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Santiago
Corradetti Approved Nov-08-2020 10:30:40 (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 10:21:44 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-06-2020 13:31:24 (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.
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861749
Page 124 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
 N/A Nov-05-2020 15:06:23 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-03-2020 12:17:41 (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.
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861750
Page 125 of 193
***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: 12311409 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-15-2020 16:35:03
(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-15-2020 16:35:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861751
Page 126 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-15-2020 16:35:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/15/2020Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861752
Page 127 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-15-2020 16:34:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12311409Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-15-2020 16:34:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1982Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-15-2020 16:35:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-15-2020 16:35:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-15-2020 16:35:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861753
Page 128 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-29-2020 03:19:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-28-2020 19:46:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The option Not
applicable is indicated
in the remaining
forms of visit 1.
Withdrawal of consent
from the volunteer
both for the study
treatment, procedures
and subsequent
follow-up. Thank you
Sep-28-2020 12:00:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opened Please consider
entering Not
Applicable for these
two forms.
Sep-28-2020 08:23:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered This subject was
discontinued before
finishing the visit
process.
Sep-28-2020 06:00:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM Query: Kindly
review and complete
‘Vaccination and
Reactogenecity ' at
this visit. Thank you.
Aug-21-2020 10:17:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (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-2021-5683-0861754
Page 129 of 193
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 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 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants b
etween the ages of 18 and 55
years, inclusive, 65 and 85 ye
ars, inclusive, or 18 and 85 ye
ars, inclusive, at randomizatio
n (dependent upon study stag
e)
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Male or female participants between th
e ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 y
ears, inclusive, at randomization (depe
ndent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861755
Page 130 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-21-2020 10:17:48
(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 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Desc
ription:Participants who are willing
and able to comply with all s
cheduled visits, vaccination
plan, laboratory tests, lifestyl
e considerations, and other st
udy procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN02A00Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861756
Page 131 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Inclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participants who are willing and able t
o comply with all scheduled visits, vac
cination plan, laboratory tests, lifestyle
considerations, and other study proced
uresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who are
determined by medical histor
y, physical examination, and
clinical judgment of the inve
stigator to be eligible for incl
usion in the studyInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861757
Page 132 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Healthy participants who are determin
ed by medical history, physical examin
ation, and clinical judgment of the inve
stigator to be eligible for inclusion in t
he studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusi4Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861758
Page 133 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
on Nu
mber:
Criteri
on Desc
ription:Capable of giving personal si
gned informed consent, whic
h includes compliance with t
he requirements and restricti
ons listed in the ICD and in t
his protocol
Criteri
on met
?:YES
Criteri
on ID: (
For Pfi
zer use
only):IN04A00
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861759
Page 134 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Inclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Capable of giving personal signed info
rmed consent, which includes complia
nce with the requirements and restricti
ons listed in the ICD and in this protoc
olInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatric
condition incl. recent (within
past year) or active suicidal i
deation/behavior/lab abnorm
ality that may increase the ris
k of study participationInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861760
Page 135 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 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):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 abnorma
lity that may increase the risk of study
participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusio 2Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861761
Page 136 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
n Numbe
r:
Criterion
Descripti
on:Known infection with hum
an immunodeficiency virus
(HIV), hepatitis C virus (H
CV), or hepatitis B virus (
HBV)
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX02A00
2.b Exclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(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 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861762
Page 137 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Desc
ription:History of severe adverse rea
ction associated with a vacci
ne and/or severe allergic reac
tion (eg, anaphylaxis) to any
component of the study inter
vention(s)
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX03A00Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861763
Page 138 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Exclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
History of severe adverse reaction asso
ciated with a vaccine and/or severe alle
rgic reaction (eg, anaphylaxis) to any c
omponent of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:4
Criterion Desc
ription:Receipt of medication
s intended to prevent
COVID-19
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX04A00Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861764
Page 139 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.d Exclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(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 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:8
Criterio
n Descri
ption:Immunocompromised indivi
duals with known or suspect
ed immunodeficiency, as det
ermined by history and/or la
boratory/physical examinati
on
Criterio
n met?:NOInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861765
Page 140 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n ID: (F
or Pfize
r use on
ly):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Immunocompromised individuals with
known or suspected immunodeficiency
, as determined by history and/or labor
atory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:10Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861766
Page 141 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Desc
ription:Bleeding diathesis or conditi
on associated with prolonged
bleeding that would, in the o
pinion of the investigator, co
ntraindicate intramuscular in
jection
Criteri
on met?
:NO
Criteri
on ID: (
For Pfi
zer use
only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition associa
ted with prolonged bleeding that would
, in the opinion of the investigator, cont
raindicate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861767
Page 142 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion Numb
er:11
Criterion Descri
ption:Women who are pr
egnant or breastfee
ding
Criterion met?: NO
Criterion ID: (F
or Pfizer use onl
y):EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Women who are pregnant or breastfeed
ingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (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-2021-5683-0861768
Page 143 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aires Exclusion Num
ber:12
Criterion Desc
ription:Previous vaccination
with any coronavirus
vaccine
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Previous vaccination with any coronav
irus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:13Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (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-2021-5683-0861769
Page 144 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion
Descripti
on:Subjects who receive imm
unosuppressive therapy, su
ch as cytotoxic agents or s
ystemic corticosteroids
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Subjects who receive immunosuppress
ive therapy, such as cytotoxic agents or
systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry:
Exclusi15Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861770
Page 145 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aires on Num
ber:
Criterio
n Descr
iption:Receipt of blood/plasma pro
ducts or immunoglobulin, fr
om 60 days before study inte
rvention administration or pl
anned receipt throughout the
study
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX14A01
2.j Exclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products or i
mmunoglobulin, from 60 days before s
tudy intervention administration or pla
nned receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861771
Page 146 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.k
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other studie
s involving study interventi
on within 28 days prior to s
tudy entry and/or during stu
dy participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX15A01Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861772
Page 147 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Exclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other studies involving
study intervention within 28 days prior
to study entry and/or during study part
icipationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in
other studies involving st
udy intervention containi
ng lipid nanoparticles
Criterion
met?:NOInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861773
Page 148 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion
ID: (For P
fizer use o
nly):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(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 10:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:22Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861774
Page 149 of 193
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Investigator site staff or Pfize
r employees directly involve
d in the conduct of the study,
site staff otherwise supervise
d by the investigator, and thei
r respective family members
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX21A01
2.m Exclusion Number:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-21-2020 10:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer employ
ees directly involved in the conduct of
the study, site staff otherwise supervis
ed by the investigator, and their respec
tive family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-21-2020 10:17:48
(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 10:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861775
Page 150 of 193
***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: 12311409 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 10:18:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-21-2020 10:18:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-21-2020 10:18:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861776
Page 151 of 193
***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: 12311409 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 10:19:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-21-2020 10:19:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
54.25Initial Entry
3. Unit:
Date Location User Value Reason
Aug-21-2020 10:19:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-21-2020 10:19:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
188.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-21-2020 10:19:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-21-2020 10:19:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15.3Initial Entry
7.a
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861777
Page 152 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-21-2020 10:19:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.4
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-21-2020 10:19:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-21-2020 10:19:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-21-2020 10:19:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-21-2020 10:19:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861778
Page 153 of 193
***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: 12311409 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 10:19:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020 01:26:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed As per site response
Aug-24-2020 21:26:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Query 1: Answered Subject left after
blood sample was
collected and dis not
receive study
intervention, based on
medical record
Aug-24-2020 09:15:56
(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 10:19:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
51472Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861779
Page 154 of 193
***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: 12311409 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 10:19:54
(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 10:19:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 19:35:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-21-2020 11:00:52
(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 10:19:54
(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 10:19:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/15/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861780
Page 155 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-21-2020 19:35:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BM83YXInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020 19:35:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BM83YXInitial Entry
5.b
Date Location User Value Reason
Aug-21-2020 19:35:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BM83YYInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-21-2020 19:35:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BM83YYInitial Entry
5.c
Date Location User Value Reason
Aug-21-2020 19:36:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BM83YZInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-21-2020 19:36:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BM83YZInitial Entry
5.d
Date Location User Value Reason
Aug-23-2020 19:38:01
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
Sample ID: BLCVPZInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861781
Page 156 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
5.d Sample ID
Date Location User Value Reason
Aug-23-2020 19:38:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLCVPZInitial Entry
5.e
Date Location User Value Reason
Aug-23-2020 19:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLCVR0Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-23-2020 19:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLCVR0Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861782
Page 157 of 193
***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: 12311409 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 10:20:18
(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 10:20:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 10:27:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Aug-21-2020 10:21:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened 'Sample Collected?' is
marked as No and 'If
no sample was
collected or sample
was not collected
according to protocol,
please provide reason'
is missing. Please
review and update as
appropriate.
Aug-21-2020 10:21:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-21-2020 10:21:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOTranscription Error
Aug-21-2020 10:20:18
(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.
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861783
Page 158 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-21-2020 10:20:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/15/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Aug-21-2020 10:27:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
After blood extraction with complicati
ons, the volunteer decide not to contin
ue with the study so no swabbing and
no other procedure was performedInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861784
Page 159 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-28-2020 19:45:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020 19:45:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020 19:45:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Oct-30-2020
05:16:21
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Oct-29-2020
12:33:56
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Ans
weredThe subject decided to
withdraw consent after blood
collection, so no vaccination
was carried out. Thank you
Oct-28-2020
22:29:03
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW5210910;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
review and update as
appropriate.
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (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-2021-5683-0861785
Page 160 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-28-2020
19:45:08
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Not A
pplica
bleInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020 19:45:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-28-2020 19:45:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Route:
Date Location User Value Reason
Sep-28-2020 19:45:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Actual Dose:
Date Location User Value Reason
Sep-28-2020 19:45:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Unit:
Date Location User Value Reason
Sep-28-2020 19:45:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (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-2021-5683-0861786
Page 161 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-28-2020 19:45:08
(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
Sep-28-2020 19:45:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861787
Page 162 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-28-2020 19:45:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861788
Page 163 of 193
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-07-2020 10:23:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Nov-07-2020 10:23:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861789
Page 164 of 193
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Nov-07-2020 10:23:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.a
Date Location User Value Reason
Nov-07-2020 10:23:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: Not Done
Temperature: Not Done
Temperature Unit: Not Done
Temperature Location:: Not DoneInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-07-2020 10:23:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.a Temperature:
Date Location User Value Reason
Nov-07-2020 10:23:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.a Unit:
Date Location User Value Reason
Nov-07-2020 10:23:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-07-2020 10:23:37
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (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-2021-5683-0861790
Page 165 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861791
Page 166 of 193
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-07-2020 10:23:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-07-2020 10:23:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-07-2020 10:23:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-07-2020 10:23:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861792
Page 167 of 193
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 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
Nov-07-2020 10:24:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-07-2020 10:24:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-07-2020 10:24:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Nov-08-2020
10:41:38
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-07-2020
18:30:12
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Ans
weredOriginal value is correct
Nov-07-2020
17:40:19
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5310465;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
review and update as
appropriate.
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (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-2021-5683-0861793
Page 168 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Nov-07-2020
10:24:03
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Not D
oneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-07-2020 10:24:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-07-2020 10:24:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Nov-07-2020 10:24:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Nov-07-2020 10:24:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Nov-07-2020 10:24:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-07-2020 10:24:03 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861794
Page 169 of 193
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresNot Done
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Nov-07-2020 10:24:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861795
Page 170 of 193
***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: 12311409 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-07-2020 10:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Nov-07-2020 10:21:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Nov-05-2020 17:48:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-05-2020 15:06:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Nov-05-2020 15:06:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-05-2020 15:06:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Nov-05-2020 14:02:21
(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 13:03:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
Aug/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-07-2020 10:23:08 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (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-2021-5683-0861796
Page 171 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos Aires(autocalc) Not Applicable
Nov-07-2020 10:21:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
Nov-05-2020 15:06:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Nov-05-2020 15:06:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Aug-21-2020 13:03:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-07-2020 10:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Nov-07-2020 10:21:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Nov-05-2020 15:06:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Nov-05-2020 15:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Aug-21-2020 13:03:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
REFUSED FURTHER STUDY P
ROCEDURESInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-07-2020 10:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Nov-07-2020 10:21:44
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (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-2021-5683-0861797
Page 172 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
Nov-05-2020 15:06:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861798
Page 173 of 193
***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: 12311409 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-17-2020 14:17:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Nov-17-2020 10:13:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Nov-17-2020 10:13:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Changed Information
Nov-13-2020 14:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 1: Reissued:Opened CLINQUERY: Since
the subject declined
to proceed with the
study/vax 1 due to
AEs linked to
phlebotomy, we
would like
ADVERSE EVENT
captured as status on
this page to link with
matching date.
Consent withdrawal
can be captured on
the WOC page
Nov-12-2020 14:59:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered On Aug 15, 2020 he
declined to receive
vaccination, but on
Sep 25, 2020 he
withdrew his
informed consent
Nov-12-2020 12:36:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: Please
review what this date
relates to that is
entered as end of
study. Per CRF, the
subject declined to
receive vaccination at
V1 on 15Aug20.
Thank you for
clarifying.
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861799
Page 174 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-28-2020 16:15:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-28-2020 16:15:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-17-2020 10:16:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 5: Closed Close Auto Query
Nov-17-2020 10:12:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 5: Opened Response to "Status"
is ADVERSE EVENT
but "Specify Status" is
Provided.
Nov-17-2020 10:12:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ADVERSE EVENTChanged Information
Nov-13-2020 18:41:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-13-2020 09:30:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
Nov-13-2020 09:28:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened Response to "Status"
is WITHDRAWAL
BY SUBJECT but
"Specify Status" is
missing.
Nov-13-2020 09:28:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Answer Auto Query
Nov-13-2020 09:28:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WITHDRAWAL BY SUBJECTTranscription Error
Nov-13-2020 05:10:07 ACV0PFEINFP6000  Query 2: Reissued:Opened As per WOC form
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861800
Page 175 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos Airescompleted, if subject
withdrew consent
please consider
updating this field to
WITHDRAWAL by
SUBJECT and
provide reason at
'Specify status;' field
on this CRF.
Nov-12-2020 12:37:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Nov-12-2020 11:01:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered Changed data per
query
Nov-12-2020 11:01:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Nov-12-2020 10:59:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Response to "Status"
is ADVERSE EVENT
but "Specify Status" is
Provided.
Nov-12-2020 10:59:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: 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.
Nov-12-2020 10:59:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-12-2020 10:59:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ADVERSE EVENTTranscription Error
Nov-12-2020 08:37:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY: It
appears through
information in the
CRF that this subject
may have ceased
participation in the
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861801
Page 176 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
study due to adverse
event related to the
phlebotomy. If so,
please capture here
the status as
ADVERSE EVENT
as the priority reason
Nov-12-2020 06:55:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 1: Candidate CLINQUERY: It
appears through
information in the
CRF that this subject
may have ceased
participation in the
study due to adverse
event related to the
phlebotomy. If so,
please capture here
the status as
ADVERSE EVENT
as the priority reason
Oct-28-2020 16:15:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-17-2020 10:16:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Nov-17-2020 10:14:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
the subject declined to proceed wit
h the study due to AEs linked to p
hlebotomyChanged Information
Nov-13-2020 09:30:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
the subject decided to withdraw th
e consent.Initial Entry
Nov-12-2020 11:01:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Oct-28-2020 16:15:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
subject decided to withdraw conse
ntInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (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-2021-5683-0861802
Page 177 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Oct-23-2020 13:04:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861803
Page 178 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Oct-23-2020 13:46:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861804
Page 179 of 193
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Oct-28-2020 14:06:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Marjorie
BuonannoQuery 1: Closed entered in error
Oct-27-2020 10:54:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Marjorie
BuonannoQuery 1: Opened GPD Clin: Please
confirm that
SYNCOPE WAS or
WAS NOT
associated with a
study procedure (e.g.
blood drawn or
physical
examination)
Oct-23-2020 13:04:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-23-2020 13:04:22
(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
Nov-02-2020
16:33:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Nov-02-2020
10:07:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Answered Changed data per
query
Oct-31-2020
13:38:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Reissued:
Openedclinical-Thank
you. pls add this
info under: Not
related, other=
post phlebotomy
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861805
Page 180 of 193
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-30-2020
16:42:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Answered The syncope
occurred after the
blood extraction
of visit 1. After
this episode, the
subject decided to
withdraw his
consent and no
longer participate
in the study, so no
swab was
performed.
Oct-30-2020
09:35:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Opened clinical: pls
advise if patient
had nasal swab,
phlebotomy
performed and
what temporal
relationship of
syncopal event
was to these
procedures if
done.
Oct-26-2020
16:53:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Oct-26-2020
12:11:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Oct-26-2020
12:11:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SyncopeTranscription
Error
Oct-23-2020
19:29:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opened Special
Characters:
Verbatim Term
contains
embedded
non-compliant
characters.
Oct-23-2020
13:04:22
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
SyncopeInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (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-2021-5683-0861806
Page 181 of 193
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
4. Start Date Time:
Date Location User Value Reason
Oct-23-2020 13:04:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020 15:40Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-23-2020 13:04:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/15/2020 15:41Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-23-2020 13:04:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  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
Oct-23-2020 13:04:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-23-2020 13:04:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861807
Page 182 of 193
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-02-2020 10:07:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
post phlebotomyTranscription Error
Oct-23-2020 13:04:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
stress situationInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-23-2020 13:04:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-23-2020 13:04:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-23-2020 13:04:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861808
Page 183 of 193
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Oct-23-2020 13:04:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-12-2020 12:37:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 2: Closed Response satisfies
query
Nov-12-2020 11:42:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Nov-12-2020 11:42:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESTranscription Error
Nov-12-2020 08:38:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened CLINQUERY: It
appears through
information in the
CRF that the AEs
following phlebotomy
may have contributed
to the decision to
withdraw from the
study. If so, please
update these fields to
'yes' as an AE would
take priority for end of
study reason
Nov-12-2020 06:58:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 2: Candidate CLINQUERY: It
appears through
information in the
CRF that the AEs
following phlebotomy
may have contributed
to the decision to
withdraw from the
study. If so, please
update these fields to
'yes' as an AE would
take priority for end of
study reason
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861809
Page 184 of 193
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-26-2020 16:43:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-26-2020 16:43:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOtranscription error. It
is a withdrawal of
consent
Oct-24-2020 11:40:51
(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.
Oct-23-2020 13:04:22
(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.
Oct-23-2020 13:04:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861810
Page 185 of 193
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Oct-23-2020 13:46:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-23-2020 13:46:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-28-2020 13:36:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Marjorie
BuonannoQuery 1: Closed Response satisfies
query
Oct-28-2020 09:02:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered As stated in medical
record, vomiting was
associated to post
sincopal recovery
after blood drawn
Oct-27-2020 10:55:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Marjorie
BuonannoQuery 1: Opened GPR Clin:confirm
that VOMITING
WAS or WAS NOT
associated with a
study procedure (e.g.
blood drawn or
physical
examination)
Oct-23-2020 13:46:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
vomitsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-23-2020 13:46:54 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861811
Page 186 of 193
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresAug/15/2020 15:30
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-23-2020 13:46:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/15/2020 15:40Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-23-2020 13:46:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-23-2020 13:46:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-23-2020 13:46:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-28-2020 09:01:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(Changed Information
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (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-2021-5683-0861812
Page 187 of 193
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
s), this event is due to:
OTHER
If Other, specify:
post sincopal recovery
Oct-23-2020 13:46:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
stress situationInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-23-2020 13:46:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-23-2020 13:46:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-23-2020 13:46:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-23-2020 13:46:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861813
Page 188 of 193
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-13-2020 11:54:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-12-2020 12:37:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Nov-12-2020 12:25:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered The volunteer decided
not to continue with
the visits scheduled
according to the
protocol, since he did
not want to go
through procedures
such as blood
extraction, after what
happened.
Nov-12-2020 11:43:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened More than 1 AE for
this patient has "Did
the adverse event
cause the subject to
be discontinued from
the study?" marked as
'Yes'.
Nov-12-2020 11:43:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-12-2020 11:43:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESTranscription Error
Nov-12-2020 08:39:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY: It
appears through
information in the
CRF that the AEs
following phlebotomy
may have contributed
to the decision to
withdraw from the
study. If so, please
update these fields to
'yes' as an AE would
take priority for end
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861814
Page 189 of 193
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of study reason
Nov-12-2020 06:58:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 1: Candidate CLINQUERY: It
appears through
information in the
CRF that the AEs
following phlebotomy
may have contributed
to the decision to
withdraw from the
study. If so, please
update these fields to
'yes' as an AE would
take priority for end
of study reason
Oct-23-2020 13:46:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861815
Page 190 of 193
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - 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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Nov-17-2020
19:40:31
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1
: ClosedResponse satisfies query
Nov-17-2020
19:07:30
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:
Not Ap
plicableInitial Entry
Nov-17-2020
19:07:12
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:New Information
Nov-17-2020
19:01:52
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1
: Answe
redDisposition form changed.
Thank you
Nov-17-2020
17:36:45
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1
: Opene
dDMW5402355;‘Withdrawal
of Consent Date' is after
‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Sep-28-2020
19:47:21
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:
Sep/25/
2020Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (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-2021-5683-0861816
Page 191 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-17-2020 10:12:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged Information
Nov-13-2020 09:28:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Nov-12-2020 10:59:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Nov-05-2020 15:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Oct-28-2020 16:15:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-21-2020 13:03:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-21-2020 10:19:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-21-2020 10:18:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-17-2020 10:13:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/15/2020Changed Information
Nov-17-2020 10:12:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Changed Information
Nov-13-2020 09:28:09
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Transcription Error
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861817
Page 192 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
Nov-12-2020 10:59:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Transcription Error
Nov-05-2020 15:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Transcription Error
Nov-05-2020 15:06:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Transcription Error
Oct-28-2020 16:15:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
Aug-21-2020 13:03:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/15/2020Initial Entry
Aug-21-2020 10:19:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/15/2020Initial Entry
Aug-21-2020 10:18:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/15/2020Initial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861818
Page 193 of 193
***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: 12311409 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-03-2020 12:17:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2e91\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861819