125742 S1 M5 CRF c4591001 1231 12313345

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
202
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873557
Page 2 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/23/2020
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873558
Page 3 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Demography
1.Subject ID [12313345]
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:
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873559
Page 4 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/23/2020
2.Erroneous Visit
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873560
Page 5 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873561
Page 6 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes
compliance with the requirements and restrictions listed in the ICD and in this
protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C
virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study
intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX03A00
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873562
Page 7 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or laboratory/physical
examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that
would, in the opinion of the investigator, contraindicate intramuscular
injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873563
Page 8 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before
study intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days
prior to study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873564
Page 9 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873565
Page 10 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/23/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873566
Page 11 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[lumbar disc herniation]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873567
Page 12 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vital Signs
1.Date: Aug/23/2020
2.Weight: [105.2]
3.Unit: kg
4.Height: [186.0]
5.Unit: cm
6.Body Mass Index: [30.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873568
Page 13 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/23/2020
2.Randomization Number: [62579]
3.Randomization Group: [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873569
Page 14 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/23/2020
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 [BP2C4K]
5.bSample ID [BP2C4J]
5.cSample ID [BP2C4H]
5.dSample ID [BNV9P6]
5.eSample ID [BNV9P7]
5 fSample ID [BNV9P8]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873570
Page 15 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/23/2020
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 [BP2694]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873571
Page 16 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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/23/2020 09:40
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
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873572
Page 17 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873573
Page 18 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873574
Page 19 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vital Signs
1.Date: Sep/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873575
Page 20 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/11/2020
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 [BP1Y2V]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873576
Page 21 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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/11/2020 12:34
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
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873577
Page 22 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873578
Page 23 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [BJ51KF]
5.bSample ID [BPX10M]
5.cSample ID [BJ51L0]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873579
Page 24 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873580
Page 25 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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: [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873581
Page 26 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873582
Page 27 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873583
Page 28 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873584
Page 29 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873585
Page 30 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873586
Page 31 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873587
Page 32 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873588
Page 33 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Unplanned Assessments
1.Assessments
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873589
Page 34 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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: [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873590
Page 35 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873591
Page 36 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873592
Page 37 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873593
Page 38 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873594
Page 39 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873595
Page 40 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873596
Page 41 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873597
Page 42 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873598
Page 43 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/4/2021
2.Erroneous Visit
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873599
Page 44 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873600
Page 45 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873601
Page 46 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/12/2021
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873602
Page 47 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873603
Page 48 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Mar/12/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873604
Page 49 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/12/2021
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 [BR1P70]
5.bSample ID [BRYF87]
5.cSample ID [BRYF8G]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873605
Page 50 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/12/2021
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 [BR211C]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873606
Page 51 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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/12/2021 11:13
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
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873607
Page 52 of 202
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873608
Page 53 of 202
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873609
Page 54 of 202
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873610
Page 55 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873611
Page 56 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873612
Page 57 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873613
Page 58 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873614
Page 59 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873615
Page 60 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873616
Page 61 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873617
Page 62 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  low back pain  Sep/25/2020
08:00 NO
End Date Time:
Oct/2/2020 08:00
 Repeating
Pages
 2.ADVERSE E
VENT 2  cervicalgia  Oct/12/2020 0
8:00 NO
End Date Time:
Nov/11/2020 11:00
 Repeating
Pages
 3.ADVERSE E
VENT 3  bilateral tinnitus  Oct/13/2020 0
8:00 NO
End Date Time:
Nov/25/2020 18:00
 Repeating
Pages
 4.ADVERSE E
VENT 4  Clear cell renal cell ca
rcinoma Oct/12/2020 1
8:00 YES  Repeating
Pages
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873618
Page 63 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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)[low back pain]
4.Start Date Time: Sep/25/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/2/2020 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873619
Page 64 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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:
[medical history]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873620
Page 65 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[cervicalgia]
4.Start Date Time: Oct/12/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/11/2020 11:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873621
Page 66 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873622
Page 67 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[bilateral tinnitus]
4.Start Date Time: Oct/13/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/25/2020 18:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873623
Page 68 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873624
Page 69 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Clear cell renal cell carcinoma]
4.Start Date Time: Oct/12/2020 18:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873625
Page 70 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020498020]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873626
Page 71 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873627
Page 72 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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[ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873628
Page 73 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873629
Page 74 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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: //
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873630
Page 75 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873631
Page 76 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873632
Page 77 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873633
Page 78 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873634
Page 79 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873635
Page 80 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873636
Page 81 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/4/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873637
Page 82 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873638
Page 83 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873639
Page 84 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/9/2020
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873640
Page 85 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873641
Page 86 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-17-2021 00:42:27 (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.
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873642
Page 87 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
FormNov-03-2020 13:16:23 (UTC-03:00) City of
Buenos Aires
FormAug-23-2020 13:22:15 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873643
Page 88 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
FormMar-12-2021 13:26:57 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873644
Page 89 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-17-2021 00:42:27 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-12-2021 13:24:27 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-12-2021 12:07:33 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-01-2021 13:40:08 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873645
Page 90 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Affidavit:
N/A
 Approved Feb-17-2021 11:01:16 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-11-2021 17:34:25 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-05-2021 13:45:37 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-03-2021 11:28:16 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-20-2021 17:33:56 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873646
Page 91 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-28-2020 18:27:01 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-25-2020 17:41:04 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-19-2020 15:06:14 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Nov-17-2020 08:28:30 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873647
Page 92 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-16-2020 18:47:19 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-04-2020 08:46:16 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-03-2020 13:16:23 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-02-2020 14:52:50 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873648
Page 93 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-01-2020 18:58:42 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-22-2020 09:17:39 (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.
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873649
Page 94 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-23-2020 13:20:55
(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-23-2020 13:20:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873650
Page 95 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-23-2020 13:21:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/23/2020Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873651
Page 96 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-23-2020 09:02:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12313345Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-23-2020 13:20:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
/1965Transcription Error
Aug-23-2020 09:02:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1965Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-23-2020 13:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-23-2020 13:20:46
(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-23-2020 13:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (6)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873652
Page 97 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020 14:55:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-03-2020 13:20:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Lumbar disc
herniation have
been added to
Medical History.
Thank you very
much.
Nov-03-2020 05:49:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY: per
query response for
AE of back pain
(due to "medical
history"),
"Information will
be updated on
MEDHX." please
update medical
history as
appropriate once
page is unfrozen.
Nov-02-2020 15:45:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Candidate CLINQUERY: per
query response for
AE of back pain
(due to "medical
history"),
"Information will
be updated on
MEDHX." please
update medical
history as
appropriate once
page is unfrozen.
Aug-23-2020 13:21:30 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873653
Page 98 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
(UTC-03:00) City of
Buenos AiresAug/23/2020
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873654
Page 99 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.a
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion N
umbe
r:1
Crite
rion
Descr
iption
:Male or female particip
ants between the ages of
18 and 55 years, inclusi
ve, 65 and 85 years, incl
usive, or 18 and 85 year
s, inclusive, at randomiz
ation (dependent upon s
tudy stage)
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer us
e only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873655
Page 100 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female participants bet
ween the ages of 18 and 55 year
s, inclusive, 65 and 85 years, inc
lusive, or 18 and 85 years, inclu
sive, at randomization (depende
nt upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion N
umbe
r:2
Criter
ion De
scripti
on:Participants who are wi
lling and able to compl
y with all scheduled vis
its, vaccination plan, la
boratory tests, lifestyle
considerations, and oth
er study procedures
Criter
ion m
et?:YESInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873656
Page 101 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criter
ion ID
: (For
Pfizer
use on
ly):IN02A00
1.b Inclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are willing and
able to comply with all schedule
d visits, vaccination plan, labora
tory tests, lifestyle consideration
s, and other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873657
Page 102 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion N
umbe
r:3
Criter
ion De
scripti
on:Healthy participants wh
o are determined by me
dical history, physical e
xamination, and clinical
judgment of the investi
gator to be eligible for i
nclusion in the study
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873658
Page 103 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.c Inclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants who are det
ermined by medical history, phy
sical examination, and clinical j
udgment of the investigator to b
e eligible for inclusion in the stu
dyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion N
umber4Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873659
Page 104 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
:
Criter
ion De
scripti
on:Capable of giving pers
onal signed informed c
onsent, which includes
compliance with the re
quirements and restricti
ons listed in the ICD an
d in this protocol
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN04A00
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873660
Page 105 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.d Inclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving personal sign
ed informed consent, which incl
udes compliance with the requir
ements and restrictions listed in
the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion N
umbe
r:1Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873661
Page 106 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criter
ion D
escrip
tion:Other medical or psychi
atric condition incl. rec
ent (within past year) or
active suicidal ideation/
behavior/lab abnormalit
y that may increase the
risk of study participati
on
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psychiatric co
ndition incl. recent (within past
year) or active suicidal ideation/
behavior/lab abnormality that m
ay increase the risk of study part
icipationInitial Entry
2.a Criterion met?
Date Location User Value Reason
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873662
Page 107 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:2
Criteri
on Desc
ription:Known infection with
human immunodefici
ency virus (HIV), hep
atitis C virus (HCV),
or hepatitis B virus (H
BV)
Criteri
on met?
:NO
Criteri
on ID: (
For Pfi
zer use
only):EX02A00Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873663
Page 108 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.b Exclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection with human im
munodeficiency virus (HIV), he
patitis C virus (HCV), or hepatit
is B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873664
Page 109 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criter
ion De
scripti
on:History of severe adver
se reaction associated
with a vaccine and/or s
evere allergic reaction (
eg, anaphylaxis) to any
component of the study
intervention(s)
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX03A00
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873665
Page 110 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.c Exclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adverse reacti
on associated with a vaccine an
d/or severe allergic reaction (eg,
anaphylaxis) to any component
of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion N
umber:4Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873666
Page 111 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterion D
escription:Receipt of medic
ations intended to
prevent COVID-1
9
Criterion m
et?:NO
Criterion I
D: (For Pfiz
er use only)
:EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medications intended
to prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873667
Page 112 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.e
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:8
Criteri
on Des
criptio
n:Immunocompromised i
ndividuals with known
or suspected immunod
eficiency, as determine
d by history and/or lab
oratory/physical exami
nation
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX08A00Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873668
Page 113 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.e Exclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised individua
ls with known or suspected imm
unodeficiency, as determined by
history and/or laboratory/physic
al examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873669
Page 114 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criter
ion De
scripti
on:Bleeding diathesis or c
ondition associated wit
h prolonged bleeding t
hat would, in the opini
on of the investigator, c
ontraindicate intramusc
ular injection
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX10A00
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873670
Page 115 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.f Exclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition
associated with prolonged bleed
ing that would, in the opinion of
the investigator, contraindicate i
ntramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:11Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873671
Page 116 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterion Des
cription:Women who are
pregnant or brea
stfeeding
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are pregnant or bre
astfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873672
Page 117 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion N
umber:12
Criterion D
escription:Previous vaccina
tion with any cor
onavirus vaccine
Criterion m
et?:NO
Criterion ID
: (For Pfizer
use only):EX12A00Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873673
Page 118 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.h Exclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccination with any c
oronavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:13Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873674
Page 119 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterio
n Descri
ption:Subjects who receive
immunosuppressive t
herapy, such as cytot
oxic agents or system
ic corticosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX13A01
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873675
Page 120 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.i Exclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive immunosu
ppressive therapy, such as cytot
oxic agents or systemic corticost
eroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:15Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873676
Page 121 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criter
ion De
scripti
on:Receipt of blood/plasm
a products or immunog
lobulin, from 60 days b
efore study interventio
n administration or pla
nned receipt throughou
t the study
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX14A01
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873677
Page 122 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.j Exclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma produc
ts or immunoglobulin, from 60
days before study intervention a
dministration or planned receipt
throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873678
Page 123 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
2.k
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:16
Criteri
on Des
criptio
n:Participation in other
studies involving stud
y intervention within
28 days prior to study
entry and/or during st
udy participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX15A01Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873679
Page 124 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.k Exclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other studies in
volving study intervention withi
n 28 days prior to study entry a
nd/or during study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:17Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873680
Page 125 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterio
n Descri
ption:Previous participatio
n in other studies inv
olving study interven
tion containing lipid
nanoparticles
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX16A01
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873681
Page 126 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.l Exclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participation in other s
tudies involving study intervent
ion containing lipid nanoparticl
esInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:22Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873682
Page 127 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crite
rion
Descr
iption
:Investigator site staff or
Pfizer employees direct
ly involved in the cond
uct of the study, site sta
ff otherwise supervised
by the investigator, and
their respective family
members
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX21A01
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873683
Page 128 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.m Exclusion Number:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer e
mployees directly involved in t
he conduct of the study, site staf
f otherwise supervised by the in
vestigator, and their respective f
amily membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-23-2020 13:21:51
(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-23-2020 13:21:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873684
Page 129 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-23-2020 13:22:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-23-2020 13:22:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-23-2020 13:22:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873685
Page 130 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.a
Date Location User Value Reason
Nov-03-2020 13:18:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:lumbar disc he
rniation
Start Date: UNK/UNK/20
05
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-03-2020 13:18:42
(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
Nov-03-2020 13:18:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
lumbar disc herniationInitial Entry
1.a Start Date:
Date Location User Value Reason
Nov-03-2020 13:18:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873686
Page 131 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.a Ongoing:
Date Location User Value Reason
Nov-03-2020 13:18:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873687
Page 132 of 202
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date:
Date Location User Value Reason
Aug-23-2020 13:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/23/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-23-2020 13:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
105.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-23-2020 13:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-23-2020 13:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
186.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-23-2020 13:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873688
Page 133 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020 13:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.4Initial Entry
7.a
Date Location User Value Reason
Aug-23-2020 13:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 36.8
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-23-2020 13:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-23-2020 13:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-23-2020 13:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873689
Page 134 of 202
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020 13:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873690
Page 135 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-23-2020 13:23:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/23/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-23-2020 13:23:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
62579Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873691
Page 136 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-23-2020 13:23:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-23-2020 13:23:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020 18:39:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-24-2020 02:49:22
(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.
Aug-23-2020 13:23:23
(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-23-2020 13:23:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873692
Page 137 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug/23/2020
5.a
Date Location User Value Reason
Aug-24-2020 18:39:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP2C4KInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-24-2020 18:39:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP2C4KInitial Entry
5.b
Date Location User Value Reason
Aug-24-2020 18:40:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP2C4JInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-24-2020 18:40:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP2C4JInitial Entry
5.c
Date Location User Value Reason
Aug-24-2020 18:40:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP2C4HInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873693
Page 138 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.c Sample ID
Date Location User Value Reason
Aug-24-2020 18:40:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP2C4HInitial Entry
5.d
Date Location User Value Reason
Aug-25-2020 19:36:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNV9P6Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-25-2020 19:36:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNV9P6Initial Entry
5.e
Date Location User Value Reason
Aug-25-2020 19:36:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNV9P7Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-25-2020 19:36:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNV9P7Initial Entry
5.f
Date Location User Value Reason
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873694
Page 139 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-25-2020 19:36:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNV9P8Initial Entry
5.f Sample ID
Date Location User Value Reason
Aug-25-2020 19:36:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNV9P8Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873695
Page 140 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-23-2020 13:23:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-23-2020 13:23:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020 16:50:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-24-2020 02:49:22
(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.
Aug-23-2020 13:23:30
(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-23-2020 13:23:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873696
Page 141 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug/23/2020
5.a
Date Location User Value Reason
Aug-24-2020 16:50:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP2694Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-24-2020 16:50:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP2694Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873697
Page 142 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-23-2020 13:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-23-2020 13:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-23-2020 13:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-23-2020 13:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/23/2020 09:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-23-2020 13:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873698
Page 143 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020 13:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-23-2020 13:23:53
(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-23-2020 13:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-23-2020 13:23:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873699
Page 144 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-23-2020 13:24:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873700
Page 145 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-11-2020 13:51:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873701
Page 146 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date:
Date Location User Value Reason
Sep-11-2020 13:51:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
2.a
Date Location User Value Reason
Sep-11-2020 13:51:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 36.9
Temperature Uni
t:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-11-2020 13:51:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-11-2020 13:51:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873702
Page 147 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Sep-11-2020 13:51:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-11-2020 13:51:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873703
Page 148 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020 13:51:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020 13:51:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020 19:28:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-11-2020 13:51:52
(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-11-2020 13:51:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873704
Page 149 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Sep-11-2020 19:28:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP1Y2VInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020 19:28:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP1Y2VInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873705
Page 150 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-11-2020 13:52:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020 13:52:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020 13:52:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-11-2020 13:52:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/11/2020 12:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020 13:52:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873706
Page 151 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Sep-11-2020 13:52:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-11-2020 13:52:09
(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-11-2020 13:52:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-11-2020 13:52:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873707
Page 152 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-09-2020 18:44:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873708
Page 153 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-09-2020 18:44:54
(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 18:44:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020 19:24:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-09-2020 18:44:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-09-2020 18:44:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873709
Page 154 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Oct-09-2020 19:24:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BJ51KFInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-09-2020 19:24:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BJ51KFInitial Entry
5.b
Date Location User Value Reason
Oct-09-2020 19:42:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPX10MInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-09-2020 19:42:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPX10MInitial Entry
5.c
Date Location User Value Reason
Oct-09-2020 20:00:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BJ51L0Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-09-2020 20:00:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BJ51L0Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873710
Page 155 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-09-2020 18:45:04
(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 18:45:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020 18:45:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873711
Page 156 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-05-2021 11:13:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/4/2021Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873712
Page 157 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-05-2021 11:14:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-05-2021 11:14:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Mar-05-2021 11:14:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per other protocol al
lowance(s) and confirmed t
o have received only placeb
o at Vaccination 1/2Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873713
Page 158 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021 13:24:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/12/2021Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873714
Page 159 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Consent Was:
Date Location User Value Reason
Mar-12-2021 13:25:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Mar/12/2021Initial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873715
Page 160 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-12-2021 13:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/12/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-12-2021 13:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Mar-12-2021 13:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873716
Page 161 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021 13:28:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021 13:28:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021 13:30:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-12-2021 13:28:24
(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-12-2021 13:28:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/12/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873717
Page 162 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Mar-12-2021 13:30:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR1P70Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021 13:30:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR1P70Initial Entry
5.b
Date Location User Value Reason
Mar-12-2021 13:31:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRYF87Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-12-2021 13:31:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRYF87Initial Entry
5.c
Date Location User Value Reason
Mar-12-2021 13:38:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRYF8GInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-12-2021 13:38:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRYF8GInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873718
Page 163 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021 13:28:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021 13:28:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021 14:23:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-12-2021 13:28:38
(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-12-2021 13:28:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/12/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873719
Page 164 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Mar-12-2021 14:23:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR211CInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021 14:23:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR211CInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873720
Page 165 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-12-2021 13:29:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-12-2021 13:29:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-12-2021 13:29:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-12-2021 13:29:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/12/2021 11:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-12-2021 13:29:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873721
Page 166 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Mar-12-2021 13:29:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Mar-12-2021 13:29:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-12-2021 13:29:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-12-2021 13:29:03
(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-12-2021 13:29:03
(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-12-2021 13:29:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873722
Page 167 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Date Location User Value Reason
Nov-01-2020 18:58:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873723
Page 168 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Date Location User Value Reason
Nov-01-2020 19:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873724
Page 169 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Date Location User Value Reason
Nov-01-2020 19:03:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873725
Page 170 of 202
***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: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Date Location User Value Reason
Nov-16-2020 18:53:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873726
Page 171 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Category:
Date Location User Value Reason
Nov-01-2020 18:58:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-01-2020 18:58:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-01-2020 18:58:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
low back painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-01-2020 18:58:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/25/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-01-2020 18:58:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/2/2020 08:00Initial Entry
6. Toxicity Grade:
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873727
Page 172 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Nov-01-2020 18:58:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-01-2020 18:58:42
(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
Nov-01-2020 18:58:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-03-2020
15:32:52
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1
: ClosedMH form
updated.
Nov-02-2020
21:35:44
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1
: Reissu
ed:Cand
idateDM wait for
Medical
History to be
updated with
Low Back
Pain as
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873728
Page 173 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
indicated in
query below
Nov-02-2020
15:35:29
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1
: Answe
redInformation
will be
updated on
MEDHX.
Nov-02-2020
10:54:57
(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 [medical
history]. Any
symptoms,
MH or other
key data
should be
collected on
the
appropriate
page. Please
review and
update as
necessary.
Nov-01-2020
18:58:42
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tre
atmentInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0873729
Page 174 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
(s), thi
s event
is due
to:
OTH
ER
If
Oth
er,
spe
cify
:
m
ed
ic
al
hi
st
or
y
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-01-2020 18:58:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-01-2020 18:58:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873730
Page 175 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Nov-01-2020 18:58:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-01-2020 18:58:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-01-2020 18:58:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873731
Page 176 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Category:
Date Location User Value Reason
Nov-01-2020 19:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-01-2020 19:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-01-2020 19:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cervicalgiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-01-2020 19:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/12/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-16-2020 18:47:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/11/2020 11:00New Information
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873732
Page 177 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Nov-03-2020 22:07:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-03-2020 20:20:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The event is
ongoing and has
not resolved
Nov-03-2020 17:28:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY:
please clarify if
this event has
resolved. If so,
please provide the
stop date.
Nov-01-2020 19:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-01-2020 19:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-01-2020 19:01:24
(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
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873733
Page 178 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Nov-01-2020 19:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-01-2020 19:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to
:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-01-2020 19:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-01-2020 19:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-01-2020 19:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873734
Page 179 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Nov-16-2020
18:47:45 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-16-2020
18:47:45 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
DNew Information
Nov-16-2020
18:47:19 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE
cervicalgia:
Response to "What
was the outcome of
this adverse
event?" is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Nov-01-2020
19:01:24 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT
RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-01-2020 19:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873735
Page 180 of 202
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Category:
Date Location User Value Reason
Nov-01-2020 19:03:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-01-2020 19:03:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-24-2020
18:30:30 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-24-2020
09:18:33 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Query 1: Answered He was evaluated
and medicated with
cyanocobalamin for
anemic syndrome.
At the moment it
was not studied for
vitamin B12
deficiency.
Nov-23-2020
15:43:08 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Query 1: Opened ANEMIA AND
TINNITUS: Since
VITAMIN B12
deficiency can
precipitate
TINNITUS, please
confirm this HAS
or HAS NOT been
assessed.
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873736
Page 181 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Nov-01-2020
19:03:35 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
bilateral tinnitusInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-01-2020 19:03:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/13/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-28-2020
18:27:01 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/25/2020 18:00New Information
Nov-24-2020
14:06:38 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-20-2020
16:26:36 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Query 2: Answered He refers to having
had an audiometry
on Nov 18, 2020
and will make an
appointment to
make a new
consultation with
an otolaryngologist
to evaluate the
study. Telephone
follow-up will be
carried out. The
adverse event
continues.
Nov-20-2020
14:38:39 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Query 2: Opened Clin: Please
confirm if this AE
is still ongoing
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873737
Page 182 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Nov-03-2020
22:08:39 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-03-2020
20:21:51 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Query 1: Answered The event is
ongoing and has
not resolved.
Nov-03-2020
17:29:50 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY:
please clarify if this
event has resolved.
If so, please
provide the stop
date.
Nov-01-2020
19:03:35 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-01-2020 19:03:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-01-2020 19:03:35
(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
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873738
Page 183 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Nov-01-2020 19:03:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-01-2020 19:03:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to
:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-01-2020 19:03:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-01-2020 19:03:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-01-2020 19:03:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (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-2021-5683-0873739
Page 184 of 202
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Nov-28-2020
18:27:20 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-28-2020
18:27:20 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
DNew Information
Nov-28-2020
18:27:01 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE bilateral
tinnitus: Response
to "What was the
outcome of this
adverse event?" is
'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Nov-01-2020
19:03:35 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT
RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-01-2020 19:03:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873740
Page 185 of 202
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020 18:53:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020 18:53:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-01-2021 17:04:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 10: Closed Response satisfies
query
Mar-01-2021 13:40:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 10: Answered New Information
Mar-01-2021 13:40:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Clear cell renal cell carcino
maNew Information
Mar-01-2021 07:19:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 10: Opened SAE RECON:
AER#2020498020,the
term was updated to
'Clear cell renal cell
carcinoma'in Safety
database while
recorded as 'in study
right renal mass' in
AE CRF. Please
confirm correct
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0873741
Page 186 of 202
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
term.If safety update
is required, please
submit a follow-up
form.
Feb-17-2021 03:38:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 9: Closed Query closed; will
follow for requested
tumor identification
information.
Feb-03-2021 11:27:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 9: Answered There is no additional
information regarding
the type of tumor yet.
When available,
information will be
updated.
Feb-03-2021 01:16:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 9: Opened Clinical Please update
tumor name when
surgical pathology is
available (in AE and
SAE)
Dec-28-2020 15:14:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 3: Closed Response satisfies
query
Dec-26-2020 13:49:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Answered Original value is
correct
Dec-26-2020 01:19:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 3: Reissued:Opened Clin: Thank you. A
protocol deviation
will be documented.
Dec-23-2020 21:23:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 8: Closed AE term updated
Dec-23-2020 13:55:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 8: Answered New Information
Dec-23-2020 13:55:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered New Information
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0873742
Page 187 of 202
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Dec-23-2020 13:55:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
in study right renal massNew Information
Dec-22-2020 20:17:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Dec-22-2020 11:22:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 8: Opened SAE RECON:
AER#2020498020,the
term was updated to
'in study right renal
mass' in Safety
database while
recorded as 'In study
anemia'in AE CRF.
Please confirm
correct term.If safety
update is required,
please submit a
follow-up form.
Dec-21-2020 18:37:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 3: Reissued:Opened Clin: The subject
experienced
DIARRHEA a
COVID-19 listed
symptom that should
have please triggered
a potential COVID
Illness Visit
irrespective of
perceived etiology or
clinical significance
Dec-21-2020 18:36:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 5: Closed Response satisfies
query
Dec-21-2020 18:36:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 4: Closed Response satisfies
query
Dec-21-2020 18:35:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 6: Closed Response satisfies
query
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0873743
Page 188 of 202
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Dec-21-2020 18:34:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 7: Closed Response satisfies
query
Dec-20-2020 19:36:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 7: Answered It is considered
related to anemic
syndrome
Dec-20-2020 19:36:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 6: Answered It is considered
related to anemic
syndrome
Dec-20-2020 19:34:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 5: Answered In communication
with the volunteer, he
refers to a poor
tolerance to the
medication, since he
has had diarrhea since
18Nov20 (before
which it is decided
not to make a home
visit since it is an
adverse effect of said
medication).
Dec-20-2020 19:32:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 4: Answered In communication
with the volunteer, he
refers to a poor
tolerance to the
medication, since he
has had diarrhea since
18Nov20 (before
which it is decided
not to make a home
visit since it is an
adverse effect of said
medication).
Dec-20-2020 19:24:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Answered In communication
with the volunteer, he
refers to a poor
tolerance to the
medication, since he
has had diarrhea since
18Nov20 (before
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0873744
Page 189 of 202
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
which it is decided
not to make a home
visit since it is an
adverse effect of said
medication).
Dec-20-2020 19:19:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered SAE follow up form
was sent
Dec-17-2020 19:40:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 7: Opened Clin: It was stated in
the SAE report
#2020498020 that the
subject experienced
HEADEACHE a
CDC-defined
symptoms of
COVID-19, please
consider whether this
symptom, could have
been due to
COVID-19 and
should have triggered
a COVID visit
Dec-17-2020 19:40:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 6: Opened Clin: It was stated in
the SAE report
#2020498020 that the
subject experienced
FATIGUE a
CDC-defined
symptoms of
COVID-19, please
consider whether this
symptom, could have
been due to
COVID-19 and
should have triggered
a COVID visit
Dec-17-2020 18:43:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 5: Opened Clin: Please the data
should still be
captured on the
appropriate CRF
pages (as for any late
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0873745
Page 190 of 202
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
data, we will still
capture it and not
ignore it) but a swab
will not be required if
symptoms have
resolved >4d
Dec-17-2020 18:42:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 4: Opened Clin: Despite
telehealth visit was
not done, please
complete the potential
COVID-19 Illness
Visit CRF forms with
all information
available. Should be
captured only on the
SOD CRF form and a
NASAL SWAB will
not be collected
Dec-17-2020 18:41:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 3: Opened Clin: It was stated in
the SAE report
#2020498020 that the
subject experienced
DIARRHEA a
COVID-19 listed
symptom that should
have please triggered
a potential COVID
Illness Visit
irrespective of
perceived etiology or
clinical significance
Dec-17-2020 18:12:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened CLINICAL Please
submit medications
prior to SAE onset on
12Oct20, to the Con
meds section of SAE,
including prn
mediations for pain
(back; cervicalgia)
Dec-16-2020 10:21:36
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
In study anemiaNew Information
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0873746
Page 191 of 202
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Buenos Aires
Nov-19-2020 19:19:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-19-2020 15:06:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Nov-19-2020 15:06:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Anemic syndrome. Hemogl
obin 11.0 g/dL (15 NOV 20
20)New Information
Nov-19-2020 14:19:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY: for the
AE of Anemic
syndrome, please
provide more
information, such as
the hemoglobin
results in the response
for this query.
Nov-16-2020 18:53:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Anemic syndromeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-16-2020 18:53:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/12/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-24-2020 14:05:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873747
Page 192 of 202
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Nov-20-2020 16:31:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered It is verified with
the volunteer that
the adverse event
continues. He is on
iron treatment.
Follow-up
continues.
Nov-20-2020 14:39:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Clin: Please
confirm if this AE
is still ongoing
Nov-16-2020 18:53:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-16-2020 10:22:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3New Information
Nov-16-2020 18:53:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-23-2020 21:23:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Dec-23-2020 13:53:42
(UTC-03:00) City ofACV0PFEINFP6000  Query 2: Answered SAE follow up
form was sent with
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0873748
Page 193 of 202
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Buenos Aires this information
090177e196ae2efb\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0873749
Page 194 of 202
***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, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313345 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
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
Dec-21-2020 15:00:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Reissued:Opened Clinical – Thank
you. If NO hospital
COVID test was
performed is
known, please
submit this
information on a
follow-up SAE
form, as pertinent
information for this
trial.
Dec-19-2020 11:41:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: A
…[truncated]
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