Document text
Page 1 of 174
***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: 12311834 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
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864112
Page 2 of 174
***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: 12311834 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/17/2020
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864113
Page 3 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12311834]
2.Birth Date: /1965
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864114
Page 4 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864115
Page 5 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for
inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes
compliance with the requirements and restrictions listed in the ICD and in this
protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864116
Page 6 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864117
Page 7 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
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
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864118
Page 8 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before
study intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX14A01
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior
to study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
2 mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of
the study, site staff otherwise supervised by the investigator, and their
respective family members
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX21A01
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864119
Page 9 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864120
Page 10 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Colon Cancer]
Start Date: Apr/3/2017
Ongoing: NO
End Date:
Nov/17/2017
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864121
Page 11 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
2.Weight: [78.85]
3.Unit: kg
4.Height: [173.0]
5.Unit: cm
6.Body Mass Index: [26.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864122
Page 12 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/17/2020
2.Randomization Number: [53315]
3.Randomization Group: [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864123
Page 13 of 174
***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: 12311834 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/17/2020
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 [BPHZ5G]
5.bSample ID [BPHZ5H]
5.cSample ID [BHWSLZ]
5.dSample ID [BHWSM0]
5.eSample ID [BHWSM1]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864124
Page 14 of 174
***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: 12311834 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/17/2020
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 [BHWSPL]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864125
Page 15 of 174
***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: 12311834 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/17/2020 17:46
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
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864126
Page 16 of 174
***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: 12311834 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
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864127
Page 17 of 174
***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: 12311834 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
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864128
Page 18 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864129
Page 19 of 174
***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: 12311834 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 [BP1TJY]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864130
Page 20 of 174
***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: 12311834 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 14:15
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
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864131
Page 21 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864132
Page 22 of 174
***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: 12311834 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/9/2020
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 [BJ51WH]
5.bSample ID [BJ51T6]
5.cSample ID [BPX14T]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864133
Page 23 of 174
***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: 12311834 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:
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864134
Page 24 of 174
***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: 12311834 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: [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864135
Page 25 of 174
***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: 12311834 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 [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864136
Page 26 of 174
***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: 12311834 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 [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864137
Page 27 of 174
***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: 12311834 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?
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864138
Page 28 of 174
***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: 12311834 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:
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864139
Page 29 of 174
***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: 12311834 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:
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864140
Page 30 of 174
***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: 12311834 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 [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864141
Page 31 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864142
Page 32 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864143
Page 33 of 174
***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: 12311834 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/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864144
Page 34 of 174
***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: 12311834 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: [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864145
Page 35 of 174
***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: 12311834 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:
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864146
Page 36 of 174
***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: 12311834 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 [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864147
Page 37 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864148
Page 38 of 174
***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: 12311834 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:
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864149
Page 39 of 174
***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: 12311834 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?
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864150
Page 40 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864151
Page 41 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864152
Page 42 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864153
Page 43 of 174
***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: 12311834 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 per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864154
Page 44 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864155
Page 45 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/25/2021
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864156
Page 46 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864157
Page 47 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Feb/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864158
Page 48 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12311834 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:
Feb/25/2021
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 [BRZ1HR]
5.bSample ID [BR1ZTN]
5.cSample ID [BRZ1K2]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864159
Page 49 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12311834 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:
Feb/25/2021
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 [BR28LL]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864160
Page 50 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/25/2021 17:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864161
Page 51 of 174
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/17/2021
2.Erroneous Visit
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864162
Page 52 of 174
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12311834 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:
Mar/17/2021
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 [BRN0LR]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864163
Page 53 of 174
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/17/2021 16:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864164
Page 54 of 174
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864165
Page 55 of 174
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864166
Page 56 of 174
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864167
Page 57 of 174
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864168
Page 58 of 174
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864169
Page 59 of 174
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864170
Page 60 of 174
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864171
Page 61 of 174
***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: 12311834 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 Hallux fracture and second toe
of the right foot Sep/16/2020
08:00 NO
End Date Time:
Oct/20/2020 19:00
Repeating
Pages
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864172
Page 62 of 174
***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: 12311834 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)[Hallux fracture and second toe of the right foot]
4.Start Date Time: Sep/16/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/20/2020 19:00
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?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864173
Page 63 of 174
***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: 12311834 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:
[work accident]
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[2020402413]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864174
Page 64 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864175
Page 65 of 174
***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: 12311834 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[ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864176
Page 66 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864177
Page 67 of 174
***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: 12311834 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: //
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864178
Page 68 of 174
***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: 12311834 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
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864179
Page 69 of 174
***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: 12311834 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?
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864180
Page 70 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864181
Page 71 of 174
***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: 12311834 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?
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864182
Page 72 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864183
Page 73 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864184
Page 74 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/10/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864185
Page 75 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864186
Page 76 of 174
***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: 12311834 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: [ ]
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864187
Page 77 of 174
***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: 12311834 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/9/2020
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864188
Page 78 of 174
***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: 12311834 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
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864189
Page 79 of 174
***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: 12311834 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-19-2021 17:02:41 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864190
Page 80 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormFeb-26-2021 11:01:57 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864191
Page 81 of 174
***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: 12311834 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-19-2021 17:02:41 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Martina
Davalli N/A Mar-17-2021 17:58:39 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-09-2021 11:14:39 (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.
Martina
Davalli N/A Feb-26-2021 11:00:54 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864192
Page 82 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Tatiana Estrada Approved Feb-16-2021 13:03:05 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, TatianaEstrada, 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-10-2021 14:39:04 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Santiago
Corradetti Approved Nov-15-2020 15:39:06 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, SantiagoCorradetti, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-14-2020 11:41:14 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Romina Libster Approved Oct-21-2020 16:45:14 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864193
Page 83 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, RominaLibster, 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.
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864194
Page 84 of 174
***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: 12311834 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-17-2020 16:13:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-17-2020 16:13:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864195
Page 85 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-17-2020 16:13:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/17/2020Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864196
Page 86 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-17-2020 16:12:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12311834Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-17-2020 16:12:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1965Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-17-2020 19:23:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-17-2020 19:23:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-17-2020 19:23:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864197
Page 87 of 174
***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: 12311834 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-17-2020 19:23:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864198
Page 88 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclu
sion
Num
ber:1
Crite
rion
Descr
iptio
n:Male or female partici
pants between the ages
of 18 and 55 years, inc
lusive, 65 and 85 years
, inclusive, or 18 and 8
5 years, inclusive, at ra
ndomization (depende
nt upon study stage)
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864199
Page 89 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresMale or female participants be
tween the ages of 18 and 55 ye
ars, inclusive, 65 and 85 years,
inclusive, or 18 and 85 years, i
nclusive, at randomization (de
pendent upon study stage)
1.a Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:2
Criter
ion D
escrip
tion:Participants who are
willing and able to co
mply with all schedul
ed visits, vaccination
plan, laboratory tests,
lifestyle consideration
s, and other study pro
cedures
Criter
ion m
et?:YESInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864200
Page 90 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion I
D: (F
or Pfi
zer us
e only
):IN02A00
1.b Inclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are willing a
nd able to comply with all sch
eduled visits, vaccination plan,
laboratory tests, lifestyle consi
derations, and other study proc
eduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864201
Page 91 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:3
Crite
rion
Descr
iption
:Healthy participants w
ho are determined by
medical history, physi
cal examination, and c
linical judgment of th
e investigator to be eli
gible for inclusion in t
he study
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer us
e only
):IN03A00Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864202
Page 92 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Inclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants who are d
etermined by medical history,
physical examination, and clin
ical judgment of the investigat
or to be eligible for inclusion i
n the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:4Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864203
Page 93 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion D
escrip
tion:Capable of giving per
sonal signed informed
consent, which includ
es compliance with th
e requirements and re
strictions listed in the
ICD and in this protoc
ol
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN04A00
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864204
Page 94 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Inclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal sig
ned informed consent, which i
ncludes compliance with the r
equirements and restrictions li
sted in the ICD and in this pro
tocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion
Num
ber:1Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864205
Page 95 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crite
rion
Descr
iption
:Other medical or psyc
hiatric condition incl.
recent (within past yea
r) or active suicidal id
eation/behavior/lab ab
normality that may inc
rease the risk of study
participation
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatric c
ondition incl. recent (within pa
st year) or active suicidal ideat
ion/behavior/lab abnormality t
hat may increase the risk of st
udy participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864206
Page 96 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Known infection wit
h human immunodef
iciency virus (HIV),
hepatitis C virus (H
CV), or hepatitis B v
irus (HBV)
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX02A00Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864207
Page 97 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.b Exclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with human i
mmunodeficiency virus (HIV)
, hepatitis C virus (HCV), or h
epatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:3Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864208
Page 98 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion D
escrip
tion:History of severe adv
erse reaction associate
d with a vaccine and/o
r severe allergic reacti
on (eg, anaphylaxis) t
o any component of t
he study intervention(
s)
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX03A00
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864209
Page 99 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Exclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adverse reac
tion associated with a vaccine
and/or severe allergic reaction
(eg, anaphylaxis) to any comp
onent of the study intervention
(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:4Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864210
Page 100 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion
Descriptio
n:Receipt of medic
ations intended t
o prevent COVI
D-19
Criterion
met?:NO
Criterion I
D: (For Pfi
zer use onl
y):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of medications intend
ed to prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864211
Page 101 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion N
umber
:8
Criter
ion De
scripti
on:Immunocompromised
individuals with kno
wn or suspected imm
unodeficiency, as dete
rmined by history and
/or laboratory/physica
l examination
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX08A00Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864212
Page 102 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e Exclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised individ
uals with known or suspected i
mmunodeficiency, as determin
ed by history and/or laborator
y/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:10Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864213
Page 103 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion De
scripti
on:Bleeding diathesis or
condition associated
with prolonged bleedi
ng that would, in the
opinion of the investi
gator, contraindicate i
ntramuscular injectio
n
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX10A00
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864214
Page 104 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.f Exclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or conditio
n associated with prolonged bl
eeding that would, in the opini
on of the investigator, contrain
dicate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion N
umber:11
Criterion De
scription:Women who ar
e pregnant or b
reastfeedingInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864215
Page 105 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are pregnant or b
reastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion 12Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864216
Page 106 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Number:
Criterion D
escription:Previous vaccin
ation with any c
oronavirus vacc
ine
Criterion m
et?:NO
Criterion I
D: (For Pfi
zer use only
):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with any
coronavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864217
Page 107 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.i
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:13
Criterio
n Descr
iption:Subjects who receiv
e immunosuppressiv
e therapy, such as cy
totoxic agents or sys
temic corticosteroid
s
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX13A01Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864218
Page 108 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.i Exclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immuno
suppressive therapy, such as c
ytotoxic agents or systemic co
rticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:15Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864219
Page 109 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion De
scripti
on:Receipt of blood/plas
ma products or immu
noglobulin, from 60 d
ays before study inter
vention administratio
n or planned receipt t
hroughout the study
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX14A01
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864220
Page 110 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.j Exclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma produ
cts or immunoglobulin, from 6
0 days before study interventi
on administration or planned r
eceipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864221
Page 111 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.k
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:16
Criteri
on Des
criptio
n:Participation in other
studies involving stu
dy intervention withi
n 28 days prior to stu
dy entry and/or durin
g study participation
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX15A01Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864222
Page 112 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Exclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other studies i
nvolving study intervention w
ithin 28 days prior to study en
try and/or during study partici
pationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:17Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864223
Page 113 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n Descri
ption:Previous participati
on in other studies i
nvolving study inte
rvention containing
lipid nanoparticles
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX16A01
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864224
Page 114 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.l Exclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participation in other
studies involving study interv
ention containing lipid nanopa
rticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion
Num
ber:22Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864225
Page 115 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crite
rion
Descr
iption
:Investigator site staff
or Pfizer employees di
rectly involved in the
conduct of the study, s
ite staff otherwise sup
ervised by the investig
ator, and their respecti
ve family members
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX21A01
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864226
Page 116 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Exclusion Number:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer
employees directly involved i
n the conduct of the study, site
staff otherwise supervised by
the investigator, and their resp
ective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020 19:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864227
Page 117 of 174
***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: 12311834 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-17-2020 19:24:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-17-2020 19:24:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-17-2020 19:24:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864228
Page 118 of 174
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-20-2020 13:05:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Colon Canc
er
Start Date: Apr/3/2017
Ongoing: NO
End Date:
Nov/17/
2017Transcription Error
Aug-18-2020 10:51:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH N
umber:1
Medical Hi
story Term
:Colon Cancer.
Fully Resolved
Start Date: Apr/3/2017
Ongoing: NO
End Date:
Nov/17/201
7Transcription Error
Aug-17-2020 19:25:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Colon Cancer
(Solved)
Start Date: Apr/3/2017
Ongoing: NO
End Date:
Nov/17/20
17Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864229
Page 119 of 174
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.a Line/MH Number:
Date Location User Value Reason
Aug-17-2020 19:25:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020
22:06:34
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 2:
ClosedDiscrepancy has
been closed.
Aug-20-2020
13:05:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 2:
AnsweredTranscription
Error
Aug-20-2020
13:05:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Ent
ry:
Colon Ca
ncerTranscription
Error
Aug-19-2020
04:26:59
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 2:
OpenedClarify COLON
CANCER.
FULLY
RESOLVED as
follows...Are you
reporting
UNEXPECTED
THERAPEUTIC
EFFECT?
PRE-EXISTING
CONDITION
IMPROVED?
CANCER
SURGERY?
THERAPY
RESPONDER?
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864230
Page 120 of 174
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
If so, update the
verbatim term as
such. Otherwise
clarify and edit
the term. Thank
you.
Aug-18-2020
23:25:05
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1:
ClosedDiscrepancy has
been closed.
Aug-18-2020
23:25:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1:
ClosedDiscrepancy has
been closed.
Aug-18-2020
10:51:31
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1:
AnsweredTranscription
Error
Aug-18-2020
10:51:31
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Ent
ry:
Colon Ca
ncer. Full
y Resolve
dTranscription
Error
Aug-18-2020
02:41:38
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1:
OpenedClarify COLON
CANCER
(SOLVED) as
follows...Clarify
SOLVED. Are
you reporting
UNEXPECTED
THERAPEUTIC
EFFECT? Other?
If so, update the
verbatim term as
such. If reporting
COLON
CANCER,
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864231
Page 121 of 174
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
update the
verbatim term as
such. Otherwise
clarify and
update the term
as appropriate.
Thank you.
Aug-17-2020
19:25:02
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Ent
ry:
Colon Ca
ncer (Solv
ed)Initial Entry
1.a Start Date:
Date Location User Value Reason
Aug-17-2020 19:25:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Apr/3/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-17-2020 19:25:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
Nov/17/2017Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864232
Page 122 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Aug-17-2020 19:25:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-17-2020 19:25:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
78.85Initial Entry
3. Unit:
Date Location User Value Reason
Aug-17-2020 19:25:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-17-2020 19:25:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
173.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-17-2020 19:25:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864233
Page 123 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-17-2020 19:25:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
26.3Initial Entry
7.a
Date Location User Value Reason
Aug-17-2020 19:25:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 36.5
Temperature Un
it:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-17-2020 19:25:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-17-2020 19:25:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-17-2020 19:25:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864234
Page 124 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-17-2020 19:25:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864235
Page 125 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-17-2020 19:25:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-17-2020 19:25:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
53315Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864236
Page 126 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020 19:25:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020 19:25:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-18-2020 18:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-18-2020 16:21:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM Query:
Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-17-2020 19:25:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-17-2020 19:25:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864237
Page 127 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug/17/2020
5.a
Date Location User Value Reason
Aug-18-2020 18:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPHZ5GInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-18-2020 18:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPHZ5GInitial Entry
5.b
Date Location User Value Reason
Aug-18-2020 18:45:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPHZ5HInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-18-2020 18:45:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPHZ5HInitial Entry
5.c
Date Location User Value Reason
Aug-18-2020 18:56:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHWSLZInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864238
Page 128 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.c Sample ID
Date Location User Value Reason
Aug-18-2020 18:56:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHWSLZInitial Entry
5.d
Date Location User Value Reason
Aug-18-2020 18:56:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHWSM0Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-18-2020 18:56:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHWSM0Initial Entry
5.e
Date Location User Value Reason
Aug-18-2020 18:56:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHWSM1Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-18-2020 18:56:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHWSM1Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864239
Page 129 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020 19:25:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020 19:25:51
(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 10:38:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-17-2020 19:25:51
(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-17-2020 19:25:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864240
Page 130 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-18-2020 10:38:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHWSPLInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-18-2020 10:38:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHWSPLInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864241
Page 131 of 174
***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: 12311834 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-17-2020 19:26:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-17-2020 19:26:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-17-2020 19:26:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-17-2020 19:26:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/17/2020 17:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-17-2020 19:26:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864242
Page 132 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-17-2020 19:26:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-17-2020 19:26:11
(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-17-2020 19:26:11
(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-17-2020 19:26:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864243
Page 133 of 174
***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: 12311834 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-17-2020 19:26:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864244
Page 134 of 174
***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: 12311834 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-13-2020 04:48:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Per site
confirmation-
Subject says that
he answered "yes"
by mistake
Oct-12-2020 19:25:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered when contact was
made subject says
that he answered
"yes" by mistake
and denied having
symptoms of any
kind. thank you
Oct-01-2020 13:13:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have
you experienced
any of the
following?” for the
COVID-19
symptoms or
diagnosis on
31AUG2020. But
there is no COVID
Illness visit
reported in the
database. Please
clarify.
Sep-07-2020 15:37:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/7/2020Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864245
Page 135 of 174
***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: 12311834 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 15:38:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/7/2020Initial Entry
2.a
Date Location User Value Reason
Sep-07-2020 15:38:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.3
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-07-2020 15:38:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-07-2020 15:38:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.3Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864246
Page 136 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-07-2020 15:38:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-07-2020 15:38:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864247
Page 137 of 174
***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: 12311834 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 15:38:21
(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 15:38:21
(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 11:30:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-08-2020 06:08:27
(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 15:38:21
(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 15:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/7/2020Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0864248
Page 138 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a
Date Location User Value Reason
Sep-08-2020 11:30:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1TJYInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-08-2020 11:30:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1TJYInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864249
Page 139 of 174
***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: 12311834 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 15:38:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-07-2020 15:38:46
(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 15:38:46
(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 15:38:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/7/2020 14:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-07-2020 15:38:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864250
Page 140 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Sep-07-2020 15:38:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-07-2020 15:38:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-07-2020 15:38:46
(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 15:38:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864251
Page 141 of 174
***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: 12311834 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-09-2020 19:36:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/9/2020Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864252
Page 142 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-09-2020 19:36:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-09-2020 19:36:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020 10:59:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-10-2020 06:20:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-09-2020 19:36:14
(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-09-2020 19:36:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864253
Page 143 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a
Date Location User Value Reason
Oct-12-2020 10:59:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ51WHInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020 10:59:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ51WHInitial Entry
5.b
Date Location User Value Reason
Oct-12-2020 12:19:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ51T6Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-12-2020 12:19:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ51T6Initial Entry
5.c
Date Location User Value Reason
Oct-12-2020 12:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPX14TInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864254
Page 144 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.c Sample ID
Date Location User Value Reason
Oct-12-2020 12:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPX14TInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864255
Page 145 of 174
***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: 12311834 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 19:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020 19:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020 19:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864256
Page 146 of 174
***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: 12311834 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-10-2021 14:39:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/10/2021Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864257
Page 147 of 174
***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: 12311834 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-10-2021 14:39:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per other protocol allo
wance(s) and confirmed to hav
e received only placebo at Vac
cination 1/2Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864258
Page 148 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12311834 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-26-2021 11:00:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Feb/25/2021Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864259
Page 149 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-26-2021 11:01:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
OBTAINED
Date Written Consent Obtaine
d
Feb/25/2021Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864260
Page 150 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 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
Feb-26-2021 11:02:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Feb/25/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-26-2021 11:02:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-26-2021 11:02:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
COMPLETEDInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864261
Page 151 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021 11:02:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021 11:02:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021 11:19:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-26-2021 11:02:31
(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.
Feb-26-2021 11:02:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021 11:19:31
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Sample ID: BRZ1HRInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864262
Page 152 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
5.a Sample ID
Date Location User Value Reason
Feb-26-2021 11:19:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRZ1HRInitial Entry
5.b
Date Location User Value Reason
Feb-26-2021 12:46:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR1ZTNInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-26-2021 12:46:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR1ZTNInitial Entry
5.c
Date Location User Value Reason
Feb-26-2021 12:57:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRZ1K2Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-26-2021 12:57:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRZ1K2Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (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-2021-5683-0864263
Page 153 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021 11:02:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021 11:02:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021 11:08:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-26-2021 11:02:49
(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.
Feb-26-2021 11:02:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021 11:08:51
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Sample ID: BR28LLInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864264
Page 154 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
5.a Sample ID
Date Location User Value Reason
Feb-26-2021 11:08:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR28LLInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864265
Page 155 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 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
Feb-26-2021 11:03:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-26-2021 11:03:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-26-2021 11:03:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-26-2021 11:03:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Feb/25/2021 17:22Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-26-2021 11:03:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864266
Page 156 of 174
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Feb-26-2021 11:03:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-26-2021 11:03:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-26-2021 11:03:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-26-2021 11:03:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-26-2021 11:03:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-26-2021 11:03:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864267
Page 157 of 174
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-17-2021 17:58:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Mar/17/2021Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864268
Page 158 of 174
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-17-2021 17:58:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-17-2021 17:58:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-18-2021 13:48:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-18-2021 08:01:22
(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.
Mar-17-2021 17:58:59
(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-17-2021 17:58:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Mar/17/2021Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864269
Page 159 of 174
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a
Date Location User Value Reason
Mar-18-2021 13:48:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BRN0LRInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-18-2021 13:48:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BRN0LRInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864270
Page 160 of 174
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 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
Mar-17-2021 17:59:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-17-2021 17:59:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-17-2021 17:59:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-17-2021 17:59:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Mar/17/2021 16:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-17-2021 17:59:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864271
Page 161 of 174
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Mar-17-2021 17:59:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Mar-17-2021 17:59:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-17-2021 17:59:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-17-2021 17:59:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-17-2021 17:59:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Mar-17-2021 17:59:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864272
Page 162 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Oct-14-2020 08:20:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0864273
Page 163 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Oct-14-2020 08:20:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-14-2020 08:20:13
(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-16-2020
20:49:53
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Clos
edDiscrepancy
has been
closed.
Oct-16-2020
18:15:57
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredNew
Information
Oct-16-2020
18:15:57
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Hallux fractur
e and second t
oe of the right
footNew
Information
Oct-14-2020
16:57:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Ope
nedMultiple
concepts in the
term WORK
ACCIDENT
WITH
FRACTURE
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864274
Page 164 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
OF THE
FIRST AND
SECOND
TOES OF
THE RIGHT
FOOT. Split
the term into
WORK
ACCIDENT
and
FRACTURE
OF THE
FIRST AND
SECOND
TOES OF
THE RIGHT
FOOT and
submit
separately.
Thank you.
Oct-14-2020
08:20:13
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Work accident
with fracture
of the first an
d second toes
of the right fo
otInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-14-2020 08:20:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/16/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-14-2020 11:41:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:New Information
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0864275
Page 165 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct/20/2020 19:00
Oct-14-2020 08:20:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-14-2020 08:20:13
(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
Oct-20-2020 05:48:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-20-2020 05:43:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-19-2020 10:06:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate For AE Hallux fracture and
second toe of the right foot:
Response to "Is the adverse
event serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Oct-19-2020 10:06:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-19-2020 10:06:38
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
YESNew Information
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0864276
Page 166 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires Is this serious event associ
ated with congenital anom
aly or birth defect?
NO
Did this serious event resu
lt in death?
NO
Did this serious event requ
ire or prolong hospitalizati
on?
NO
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
YES
Oct-17-2020 10:53:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020402413
Right hallux and second
toe fracture(onset
date:16Sep2020)was
reported as serious in
Safety database but
nonserious in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864277
Page 167 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-14-2020 08:20:13
(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-14-2020 08:20:13
(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-21-2020
18:00:33
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query 1
: ClosedResponse
satisfies query
Oct-20-2020
12:06:27
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query 1
: Answe
redIT WAS AN
ACCIDENT AT
WORK.
INFORMATION
IS CORRECT
Oct-19-2020
18:55:51
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1
: Opene
dPlease review "If
not related to
study treatment
other" field, the
following text
was indicated in
the comment
field [work
accident]. Any
symptoms, AEs
or other key data
should be
collected on the
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0864278
Page 168 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
adverse event
page. Please
review and
update as
necessary.
Oct-14-2020
08:20:13
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s), t
his ev
ent is
due to:
OTH
ER
If
Oth
er,
spe
cify
:
w
or
k
ac
ci
d
e
ntInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864279
Page 169 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-14-2020 08:20:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-14-2020 08:20:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-14-2020 08:20:13
(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-16-2020
12:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed Per confirmation from PSSR
during the call, outcome was
reported as
RECOVERED/RESOLVED.
Issue resolved
Nov-15-2020
17:17:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Candi
dateAwaiting update in safety
database.
Nov-15-2020
13:49:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Answered The result of the serious
adverse event is considered
recovered. End date 20 OCT
2020, 7:00 p m. Serious
adverse event follow-up form
was sent to the sponsor on
NOV 13, 2020. Thank you.
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0864280
Page 170 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Nov-15-2020
06:28:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened SAE
RECON:AER#2020402413
outcome was updated to
RECOVERED/RESOLVED
on AE CRF while reported as
RECOVERING/RESOLVING
in Safety database. Please
confirm correct outcome. If
safety update is required,
please submit a follow-up
form.
Nov-14-2020
11:51:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-14-2020
11:51:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLV
EDTranscription Error
Nov-14-2020
11:41:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE Hallux fracture and
second toe of the right foot:
Response to "What was the
outcome of this adverse
event?" is
'Recovering/Resolving' but
AE End Date/Time is present.
Oct-16-2020
18:20:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-16-2020
18:20:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOL
VINGTranscription Error
Oct-16-2020
18:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Hallux fracture and
second toe of the right foot:
Response to "What was the
outcome of this adverse
event?" is 3 but End
Date/Time is missing.
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0864281
Page 171 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-14-2020
08:20:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Work accident with
fracture of the first and second
toes of the right foot:
Response to "What was the
outcome of this adverse
event?" is 3 but End
Date/Time is missing.
Oct-14-2020
08:20:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-14-2020 08:20:13
(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-20-2020 05:48:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2020402413Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0864282
Page 172 of 174
***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: 12311834 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-10-2021 14:39:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/10/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-10-2021 14:39:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0864283
Page 173 of 174
***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: 12311834 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 19:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-17-2020 19:25:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-17-2020 19:24:28
(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 19:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Initial Entry
Aug-17-2020 19:25:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
Aug-17-2020 19:24:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0864284
Page 174 of 174
***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: 12311834 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020 16:45:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
LibsterData Entry:
Click Here to EnableInitial Entry
090177e196ae2f0a\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0864285