Document text
Page 1 of 162
***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: 12311579 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
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862559
Page 2 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/16/2020
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862560
Page 3 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12311579]
2.Birth Date: /1952
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862561
Page 4 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/16/2020
2.Erroneous Visit
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862562
Page 5 of 162
***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: 12311579 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
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862563
Page 6 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
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
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862564
Page 7 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or laboratory/physical
examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that
would, in the opinion of the investigator, contraindicate intramuscular
injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862565
Page 8 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before
study intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior
to study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862566
Page 9 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862567
Page 10 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862568
Page 11 of 162
***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: 12311579 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
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862569
Page 12 of 162
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/16/2020
2.Weight: [68.6]
3.Unit: kg
4.Height: [167.0]
5.Unit: cm
6.Body Mass Index: [24.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862570
Page 13 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/16/2020
2.Randomization Number: [229758]
3.Randomization Group: [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862571
Page 14 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/16/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP149Y]
5.bSample ID [BP149Z]
5.cSample ID [BP14B0]
5.dSample ID [BPHMFP]
5.eSample ID [BPHMFR]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862572
Page 15 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/16/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP156L]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862573
Page 16 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/16/2020 14:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862574
Page 17 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862575
Page 18 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/7/2020
2.Erroneous Visit
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862576
Page 19 of 162
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862577
Page 20 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/7/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1TJ5]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862578
Page 21 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/7/2020 13:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862579
Page 22 of 162
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862580
Page 23 of 162
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
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 [BPCM9N]
5.bSample ID [BPCM9P]
5.cSample ID [BPCM8G]
5.dSample ID [BPXHNC]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862581
Page 24 of 162
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/16/2021
2.Erroneous Visit
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862582
Page 25 of 162
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/16/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRZ2P0]
5.bSample ID [BRM9Z1]
5.cSample ID [BRZ2SK]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862583
Page 26 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862584
Page 27 of 162
***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: 12311579 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 [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862585
Page 28 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862586
Page 29 of 162
***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: 12311579 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 [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862587
Page 30 of 162
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 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:
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862588
Page 31 of 162
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 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: [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862589
Page 32 of 162
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 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 [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862590
Page 33 of 162
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 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 [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862591
Page 34 of 162
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 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?
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862592
Page 35 of 162
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 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:
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862593
Page 36 of 162
***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: 12311579 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:
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862594
Page 37 of 162
***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: 12311579 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 [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862595
Page 38 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862596
Page 39 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862597
Page 40 of 162
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862598
Page 41 of 162
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862599
Page 42 of 162
***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: 12311579 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:
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862600
Page 43 of 162
***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: 12311579 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 [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862601
Page 44 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862602
Page 45 of 162
***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: 12311579 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:
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862603
Page 46 of 162
***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: 12311579 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?
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862604
Page 47 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862605
Page 48 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862606
Page 49 of 162
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862607
Page 50 of 162
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862608
Page 51 of 162
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 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 [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862609
Page 52 of 162
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 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 [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862610
Page 53 of 162
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862611
Page 54 of 162
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination
1/2
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862612
Page 55 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1.ADVERSE E
VENT 1 closed fracture first phalanx r
ight little finger Sep/14/2020
19:30 NO
End Date Time:
Oct/15/2020 11:57
Repeating
Pages
2.ADVERSE E
VENT 2 Acute gastritis Oct/17/2020
10:00 NO
End Date Time:
Nov/3/2020 10:00
Repeating
Pages
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862613
Page 56 of 162
***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: 12311579 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)[closed fracture first phalanx right little finger]
4.Start Date Time: Sep/14/2020 19:30
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/15/2020 11:57
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
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862614
Page 57 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[hit with a clay pot]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862615
Page 58 of 162
***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: 12311579 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)[Acute gastritis]
4.Start Date Time: Oct/17/2020 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/3/2020 10:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862616
Page 59 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020421017]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862617
Page 60 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862618
Page 61 of 162
***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: 12311579 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[ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862619
Page 62 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862620
Page 63 of 162
***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: 12311579 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: //
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862621
Page 64 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862622
Page 65 of 162
***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: 12311579 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?
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862623
Page 66 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862624
Page 67 of 162
***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: 12311579 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?
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862625
Page 68 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862626
Page 69 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862627
Page 70 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862628
Page 71 of 162
***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: 12311579 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?
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862629
Page 72 of 162
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/5/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862630
Page 73 of 162
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862631
Page 74 of 162
***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: 12311579 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: [ ]
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862632
Page 75 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/5/2020
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862633
Page 76 of 162
***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: 12311579 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
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862634
Page 77 of 162
***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: 12311579 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 Mar-17-2021 19:01:42 (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.
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862635
Page 78 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormAug-16-2020 16:28:02 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862636
Page 79 of 162
***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: 12311579 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 Mar-17-2021 19:01:42 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-16-2021 13:43:49 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-09-2021 11:27:39 (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 Feb-05-2021 11:10:48 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862637
Page 80 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
N/A
Approved Nov-11-2020 19:23:43 (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-11-2020 08:32:10 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-30-2020 15:32:43 (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 Oct-30-2020 08:48:41 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-29-2020 18:31:19 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862638
Page 81 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-28-2020 22:31:19 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-22-2020 17:52:57 (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.
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0862639
Page 82 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-16-2020 16:26:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-16-2020 16:26:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862640
Page 83 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-16-2020 16:26:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/16/2020Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862641
Page 84 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-16-2020 12:49:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12311579Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-16-2020 12:49:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1952Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-16-2020 16:27:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-16-2020 16:27:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-16-2020 16:27:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
WHITEInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862642
Page 85 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-16-2020 16:27:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/16/2020Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862643
Page 86 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Inclu
sion
Num
ber:1
Crite
rion
Descr
iption
:Male or female particip
ants between the ages o
f 18 and 55 years, inclu
sive, 65 and 85 years, i
nclusive, or 18 and 85
years, inclusive, at rand
omization (dependent u
pon study stage)
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer us
e only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862644
Page 87 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Male or female participants bet
ween the ages of 18 and 55 yea
rs, inclusive, 65 and 85 years, i
nclusive, or 18 and 85 years, in
clusive, at randomization (depe
ndent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Inclus
ion N
umbe
r:2
Criter
ion De
scripti
on:Participants who are w
illing and able to comp
ly with all scheduled vi
sits, vaccination plan, l
aboratory tests, lifestyl
e considerations, and o
ther study procedures
Criter
ion m
et?:YESInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862645
Page 88 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion ID
: (For
Pfizer
use on
ly):IN02A00
1.b Inclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Participants who are willing an
d able to comply with all sched
uled visits, vaccination plan, la
boratory tests, lifestyle conside
rations, and other study proced
uresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
IN02A00Initial Entry
1.c
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862646
Page 89 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Inclus
ion N
umbe
r:3
Criter
ion D
escrip
tion:Healthy participants w
ho are determined by
medical history, physic
al examination, and cli
nical judgment of the i
nvestigator to be eligib
le for inclusion in the s
tudy
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862647
Page 90 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Inclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Healthy participants who are de
termined by medical history, ph
ysical examination, and clinical
judgment of the investigator to
be eligible for inclusion in the s
tudyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Inclus
ion N
umbe4Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862648
Page 91 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
r:
Criter
ion De
scripti
on:Capable of giving pers
onal signed informed c
onsent, which includes
compliance with the re
quirements and restrict
ions listed in the ICD a
nd in this protocol
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN04A00
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862649
Page 92 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Inclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Capable of giving personal sign
ed informed consent, which inc
ludes compliance with the requ
irements and restrictions listed
in the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclu
sion
Numb
er:1Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862650
Page 93 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion D
escrip
tion:Other medical or psych
iatric condition incl. re
cent (within past year)
or active suicidal ideati
on/behavior/lab abnor
mality that may increas
e the risk of study parti
cipation
Criter
ion m
et?:NO
Criter
ion I
D: (F
or Pfi
zer us
e only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Other medical or psychiatric co
ndition incl. recent (within past
year) or active suicidal ideation
/behavior/lab abnormality that
may increase the risk of study p
articipationInitial Entry
2.a Criterion met?
Date Location User Value Reason
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862651
Page 94 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusi
on Nu
mber:2
Criteri
on Desc
ription:Known infection wit
h human immunodefi
ciency virus (HIV), h
epatitis C virus (HCV
), or hepatitis B virus
(HBV)
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX02A00Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862652
Page 95 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.b Exclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Known infection with human i
mmunodeficiency virus (HIV),
hepatitis C virus (HCV), or hep
atitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclu
sion N
umbe
r:3Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862653
Page 96 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion De
scripti
on:History of severe adve
rse reaction associated
with a vaccine and/or s
evere allergic reaction
(eg, anaphylaxis) to an
y component of the stu
dy intervention(s)
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX03A00
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862654
Page 97 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Exclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
History of severe adverse reacti
on associated with a vaccine an
d/or severe allergic reaction (eg
, anaphylaxis) to any componen
t of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusion
Number:4Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862655
Page 98 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion D
escription:Receipt of medic
ations intended t
o prevent COVI
D-19
Criterion
met?:NO
Criterion I
D: (For Pfi
zer use only
):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Receipt of medications intende
d to prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX04A00Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862656
Page 99 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclus
ion Nu
mber:8
Criter
ion De
scripti
on:Immunocompromised
individuals with know
n or suspected immun
odeficiency, as determ
ined by history and/or
laboratory/physical ex
amination
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX08A00Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862657
Page 100 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e Exclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Immunocompromised individu
als with known or suspected im
munodeficiency, as determined
by history and/or laboratory/ph
ysical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclus
ion N
umber
:10Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862658
Page 101 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion De
scripti
on:Bleeding diathesis or c
ondition associated wit
h prolonged bleeding t
hat would, in the opini
on of the investigator,
contraindicate intramu
scular injection
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX10A00
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862659
Page 102 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.f Exclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Bleeding diathesis or condition
associated with prolonged blee
ding that would, in the opinion
of the investigator, contraindica
te intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusion Nu
mber:11Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862660
Page 103 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion De
scription:Women who ar
e pregnant or br
eastfeeding
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Women who are pregnant or br
eastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862661
Page 104 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusion N
umber:12
Criterion D
escription:Previous vaccina
tion with any cor
onavirus vaccine
Criterion m
et?:NO
Criterion I
D: (For Pfiz
er use only)
:EX12A00Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862662
Page 105 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.h Exclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Previous vaccination with any
coronavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusi
on Num
ber:13Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862663
Page 106 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n Descri
ption:Subjects who receive
immunosuppressive t
herapy, such as cytot
oxic agents or syste
mic corticosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX13A01
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862664
Page 107 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.i Exclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Subjects who receive immunos
uppressive therapy, such as cyt
otoxic agents or systemic cortic
osteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclus
ion Nu
mber:15Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862665
Page 108 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion De
scripti
on:Receipt of blood/plas
ma products or immun
oglobulin, from 60 day
s before study interven
tion administration or
planned receipt throug
hout the study
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX14A01
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862666
Page 109 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.j Exclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Receipt of blood/plasma produ
cts or immunoglobulin, from 6
0 days before study interventio
n administration or planned rec
eipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX14A01Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862667
Page 110 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.k
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusi
on Nu
mber:16
Criteri
on Des
criptio
n:Participation in other
studies involving stud
y intervention within
28 days prior to study
entry and/or during st
udy participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX15A01Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862668
Page 111 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Exclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Participation in other studies in
volving study intervention with
in 28 days prior to study entry
and/or during study participati
onInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusio
n Numb
er:17Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862669
Page 112 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n Descri
ption:Previous participatio
n in other studies in
volving study interv
ention containing lip
id nanoparticles
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX16A01
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862670
Page 113 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.l Exclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Previous participation in other
studies involving study interve
ntion containing lipid nanopart
iclesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclu
sion
Num
ber:22Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862671
Page 114 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crite
rion
Descr
iption
:Investigator site staff o
r Pfizer employees dire
ctly involved in the co
nduct of the study, site
staff otherwise supervi
sed by the investigator,
and their respective fa
mily members
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX21A01
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862672
Page 115 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Exclusion Number:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Investigator site staff or Pfizer
employees directly involved in
the conduct of the study, site st
aff otherwise supervised by the
investigator, and their respectiv
e family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 16:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX21A01Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862673
Page 116 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-16-2020 16:27:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-16-2020 16:27:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-16-2020 16:27:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
COMPLETEDInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862674
Page 117 of 162
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Aug-16-2020 16:28:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-16-2020 16:28:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
68.6Initial Entry
3. Unit:
Date Location User Value Reason
Aug-16-2020 16:28:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-16-2020 16:28:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
167.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-16-2020 16:28:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862675
Page 118 of 162
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020 16:28:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24.6Initial Entry
7.a
Date Location User Value Reason
Aug-16-2020 16:28:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Record Identifie
r::1
Temperature: 36.3
Temperature Un
it:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-16-2020 16:28:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-16-2020 16:28:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
36.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-16-2020 16:28:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862676
Page 119 of 162
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020 16:28:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
ORAL CAVITYInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862677
Page 120 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-16-2020 16:29:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-16-2020 16:29:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
229758Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862678
Page 121 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-16-2020 16:29:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-16-2020 16:29:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020 09:32:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-16-2020 16:29:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-16-2020 16:29:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Aug/16/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862679
Page 122 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-17-2020 09:32:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP149YInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-17-2020 09:32:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP149YInitial Entry
5.b
Date Location User Value Reason
Aug-17-2020 09:32:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP149ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-17-2020 09:32:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP149ZInitial Entry
5.c
Date Location User Value Reason
Aug-17-2020 09:32:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP14B0Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-17-2020 09:32:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP14B0Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (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-2021-5683-0862680
Page 123 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.d
Date Location User Value Reason
Aug-17-2020 15:46:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPHMFPInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-17-2020 15:46:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPHMFPInitial Entry
5.e
Date Location User Value Reason
Aug-17-2020 15:47:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPHMFRInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-17-2020 15:47:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPHMFRInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862681
Page 124 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-16-2020 16:29:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-16-2020 16:29:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-18-2020 08:59:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-16-2020 16:29:54
(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-16-2020 16:29:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Aug/16/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862682
Page 125 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-18-2020 08:59:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP156LInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-18-2020 08:59:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP156LInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862683
Page 126 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-16-2020 16:30:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-16-2020 16:30:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-16-2020 16:30:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-16-2020 16:30:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/16/2020 14:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-16-2020 16:30:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862684
Page 127 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020 16:30:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-16-2020 16:30:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-16-2020 16:30:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-16-2020 16:30:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862685
Page 128 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-16-2020 16:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862686
Page 129 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-07-2020 14:50:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/7/2020Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862687
Page 130 of 162
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Sep-07-2020 14:51:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/7/2020Initial Entry
2.a
Date Location User Value Reason
Sep-07-2020 14:51:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifi
er::1
Temperature: 36.5
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-07-2020 14:51:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-07-2020 14:51:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-07-2020 14:51:06 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (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-2021-5683-0862688
Page 131 of 162
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresC
2.a Temperature Location:
Date Location User Value Reason
Sep-07-2020 14:51:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862689
Page 132 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020 14:51:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020 14:51:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020 11:19:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-08-2020 06:07:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-07-2020 14:51:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-07-2020 14:51:16
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862690
Page 133 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires Date of Collection:
Sep/7/2020
5.a
Date Location User Value Reason
Sep-08-2020 11:19:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1TJ5Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-08-2020 11:19:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1TJ5Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862691
Page 134 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-07-2020 14:51:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-07-2020 14:51:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-07-2020 14:51:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-07-2020 14:51:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/7/2020 13:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-07-2020 14:51:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862692
Page 135 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-07-2020 14:51:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-07-2020 14:51:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-07-2020 14:51:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-07-2020 14:51:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862693
Page 136 of 162
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-05-2020 14:06:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Oct/5/2020Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862694
Page 137 of 162
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-05-2020 14:07:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-05-2020 14:07:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020 18:52:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-05-2020 14:07:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-05-2020 14:07:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862695
Page 138 of 162
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-05-2020 18:52:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BPCM9NInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-05-2020 18:52:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BPCM9NInitial Entry
5.b
Date Location User Value Reason
Oct-05-2020 18:52:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BPCM9PInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-05-2020 18:52:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BPCM9PInitial Entry
5.c
Date Location User Value Reason
Oct-05-2020 18:54:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPCM8GInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-05-2020 18:54:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPCM8GInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862696
Page 139 of 162
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.d
Date Location User Value Reason
Oct-06-2020 09:23:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPXHNCInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-06-2020 09:23:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPXHNCInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862697
Page 140 of 162
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User ValueReason
Mar-19-2021
02:59:03
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: Clo
sedAs per site
confirmation -
updated PD
tracker
Mar-18-2021
13:13:27
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Santiago Corradetti Query
1: An
swere
dDate of visit at
V4_MONTH6_L
is indeed out of
window for 1
days from
V2_VAX2_L
DOV. V4 was
delayed due to
subject's agenda
issues. Thank
you.
Mar-18-2021
02:44:51
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedPDQ: Date of
visit at
V4_MONTH6_L
is out of window
for 1 days from
V2_VAX2_L
DOV or V2
Vaccination date.
Please verify and
update. Else,
confirm in query
response
appropriately.
Mar-16-2021
13:43:49
(UTC-03:00)ACV0PFEINFP6000 Data
Entry
:Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862698
Page 141 of 162
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
City of
Buenos
AiresMar/1
6/202
1
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862699
Page 142 of 162
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-16-2021 13:44:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-16-2021 13:44:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-16-2021 16:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-16-2021 13:44:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-16-2021 13:44:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/16/2021Initial Entry
5.a
Date Location User Value Reason
Mar-16-2021 16:03:39 ACV0PFEINFP6000 Alan Colombo Data Entry: Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862700
Page 143 of 162
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresSample ID: BRZ2P0
5.a Sample ID
Date Location User Value Reason
Mar-16-2021 16:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BRZ2P0Initial Entry
5.b
Date Location User Value Reason
Mar-17-2021 09:21:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BRM9Z1Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-17-2021 09:21:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BRM9Z1Initial Entry
5.c
Date Location User Value Reason
Mar-17-2021 10:59:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRZ2SKInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-17-2021 10:59:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRZ2SKInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862701
Page 144 of 162
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-09-2020 23:47:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020 23:47:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020 23:47:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862702
Page 145 of 162
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-05-2021 11:11:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/5/2021Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862703
Page 146 of 162
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-05-2021 11:11:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862704
Page 147 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Oct-07-2020 15:48:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862705
Page 148 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Oct-28-2020 22:31:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862706
Page 149 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Oct-07-2020 15:48:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-07-2020 15:48:58
(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
Oct-07-2020 15:48:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
closed fracture first phalanx right
little fingerInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-07-2020 15:48:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/14/2020 19:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 14:14:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/15/2020 11:57New Information
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862707
Page 150 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-07-2020 15:48:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-07-2020 15:48:58
(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-07-2020 15:48:58
(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-07-2020 15:48:58
(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-13-2020 03:17:59
(UTC-03:00) City ofACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (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-2021-5683-0862708
Page 151 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
Oct-12-2020 18:28:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-12-2020 18:28:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Julieta Gelardi Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
hit with a clay potNew Information
Oct-12-2020 08:40:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: The response
for "Is this event
related to study
treatment" Is
reported as 'Not
Related', however
response for,
'Please indicate
what this event is
due to' is missing.
Kindly review and
update.
Oct-07-2020 15:48:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-07-2020 15:48:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862709
Page 152 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Oct-07-2020 15:48:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-07-2020 15:48:58
(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-16-2020 14:14:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-16-2020 14:14:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Oct-16-2020 14:14:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE closed fracture
first phalanx right little
finger: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-07-2020 15:48:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVIN
GInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862710
Page 153 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Oct-07-2020 15:48:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862711
Page 154 of 162
***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: 12311579 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 22:31:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-28-2020 22:31:19
(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 22:31:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Acute gastritisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020 22:31:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/17/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-11-2020 08:32:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/3/2020 10:00New Information
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862712
Page 155 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-28-2020 22:31:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-28-2020 22:31:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-03-2020 02:16:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Nov-02-2020 23:43:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Query 2: Answered Information was
sent to follow up
team and study
coordinators to
update SAE form.
Nov-01-2020 21:03:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Opened Clinical – Thank
you. If NO hospital
COVID test was
performed is
known, please
submit this
information on a
follow-up SAE
form, as pertinent
information for this
trial.
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862713
Page 156 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-31-2020 18:41:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered It is clarified that a
test for Covid was
not performed
because the adverse
event is not
associated with
Covid disease, in
addition the patient
did not present
symptoms of Covid
disease.
Oct-30-2020 21:01:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened Clinical COVID
testing has not been
reported in the
SAE submitted to
safety. Please
submit a follow-up
SAE form
[#2020421017] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Oct-29-2020 14:58:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Deleted Query is invalid or
does not apply
Oct-28-2020 22:31:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Acute
gastritis: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Oct-28-2020 22:31:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associ
ated with congenital anom
aly or birth defect?
NOInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862714
Page 157 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Did this serious event resu
lt in death?
NO
Did this serious event requ
ire or prolong hospitalizati
on?
YES
Did this serious event resu
lt in persistent or significa
nt disability/incapacity?
NO
Is this serious event life th
reatening?
NO
Other medically important
serious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-28-2020 22:31:19
(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 22:31:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatmenInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862715
Page 158 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
t(s), this event is due to:
OTHER
If Other, specify:
unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-28-2020 22:31:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-28-2020 22:31:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-28-2020 22:31:19
(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
Nov-11-2020 08:32:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-11-2020 08:32:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-11-2020 08:32:10
(UTC-03:00) City ofACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Acute
gastritis: Response to
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862716
Page 159 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires "What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-28-2020 22:31:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVIN
GInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-28-2020 22:31:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-30-2020 08:48:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2020421017Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862717
Page 160 of 162
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-05-2021 11:10:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/5/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-05-2021 11:10:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0862718
Page 161 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-09-2020 23:47:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-16-2020 16:29:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-16-2020 16:27:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-09-2020 23:47:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/5/2020Initial Entry
Aug-16-2020 16:29:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/16/2020Initial Entry
Aug-16-2020 16:27:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/16/2020Initial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0862719
Page 162 of 162
***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: 12311579 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020 17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Fernando
PolackData Entry:
Click Here to EnableInitial Entry
090177e196ae2e68\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0862720