Document text
Page 1 of 171
***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: 12312893 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
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871260
Page 2 of 171
***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: 12312893 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/21/2020
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871261
Page 3 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Demography
1.Subject ID [12312893]
2.Birth Date: 1943
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871262
Page 4 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/21/2020
2.Erroneous Visit
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871263
Page 5 of 171
***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: 12312893 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
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871264
Page 6 of 171
***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: 12312893 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
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871265
Page 7 of 171
***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: 12312893 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
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871266
Page 8 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents
or systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before
study intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX14A01
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days
prior to study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871267
Page 9 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention
containing lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct
of the study, site staff otherwise supervised by the investigator, and their
respective family members
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX21A01
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871268
Page 10 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871269
Page 11 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Arterial hypertension]
Start Date: Jun/6/2003
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Polyglobulia]
Start Date: Mar/1/2020
Ongoing: YES
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871270
Page 12 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vital Signs
1.Date: Aug/21/2020
2.Weight: [91.05]
3.Unit: kg
4.Height: [180.0]
5.Unit: cm
6.Body Mass Index: [28.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871271
Page 13 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/21/2020
2.Randomization Number: [236432]
3.Randomization Group: [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871272
Page 14 of 171
***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: 12312893 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/21/2020
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 [BJ4986]
5.bSample ID [BJ4987]
5.cSample ID [BHY5T0]
5.dSample ID [BHY5T1]
5.eSample ID [BHY5T2]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871273
Page 15 of 171
***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: 12312893 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/21/2020
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 [BHY658]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871274
Page 16 of 171
***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: 12312893 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/21/2020 14:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871275
Page 17 of 171
***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: 12312893 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
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871276
Page 18 of 171
***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: 12312893 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
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871277
Page 19 of 171
***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: 12312893 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: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871278
Page 20 of 171
***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: 12312893 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 [BP1Y2L]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871279
Page 21 of 171
***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: 12312893 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: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871280
Page 22 of 171
***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: 12312893 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
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871281
Page 23 of 171
***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: 12312893 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 [BNTMKF]
5.bSample ID [BNTMHG]
5.cSample ID [BKPDXK]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871282
Page 24 of 171
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871283
Page 25 of 171
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 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 [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871284
Page 26 of 171
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871285
Page 27 of 171
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 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 [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871286
Page 28 of 171
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871287
Page 29 of 171
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 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 [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871288
Page 30 of 171
***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: 12312893 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:
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871289
Page 31 of 171
***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: 12312893 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: [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871290
Page 32 of 171
***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: 12312893 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 [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871291
Page 33 of 171
***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: 12312893 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 [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871292
Page 34 of 171
***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: 12312893 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?
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871293
Page 35 of 171
***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: 12312893 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:
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871294
Page 36 of 171
***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: 12312893 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:
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871295
Page 37 of 171
***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: 12312893 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 [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871296
Page 38 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871297
Page 39 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Unplanned Assessments
1.Assessments
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871298
Page 40 of 171
***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: 12312893 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: [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871299
Page 41 of 171
***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: 12312893 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: [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871300
Page 42 of 171
***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: 12312893 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:
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871301
Page 43 of 171
***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: 12312893 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 [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871302
Page 44 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871303
Page 45 of 171
***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: 12312893 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:
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871304
Page 46 of 171
***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: 12312893 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?
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871305
Page 47 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871306
Page 48 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871307
Page 49 of 171
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871308
Page 50 of 171
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871309
Page 51 of 171
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 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 [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871310
Page 52 of 171
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 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 [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871311
Page 53 of 171
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871312
Page 54 of 171
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871313
Page 55 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1. DELETED ADVERSE
EVENT 1 polyglobulia un
der study Oct/6/2020
10:30 NO
End Date Time:
Oct/6/2020 11:30
Repeating
Pages
2. ADVERSE
EVENT 2 Polycythemia v
era Dec/15/202
0 17:00 YES Repeating
Pages
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871314
Page 56 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[polyglobulia under study ]
4.Start Date Time: Oct/6/2020 10:30
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/6/2020 11:30
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
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871315
Page 57 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871316
Page 58 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 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)[Polycythemia vera]
4.Start Date Time: Dec/15/2020 17:00
5.Is the adverse event still
ongoing?YES
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).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871317
Page 59 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
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[2020502098]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871318
Page 60 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
1. Repeating
Pages
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871319
Page 61 of 171
***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: 12312893 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[ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871320
Page 62 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart
DateForm Instanc
e
1. Repeating
Pages
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871321
Page 63 of 171
***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: 12312893 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: //
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871322
Page 64 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871323
Page 65 of 171
***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: 12312893 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?
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871324
Page 66 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Categor
yTreatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871325
Page 67 of 171
***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: 12312893 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?
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871326
Page 68 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871327
Page 69 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871328
Page 70 of 171
***Confidential***
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871329
Page 71 of 171
***Confidential***
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Booster Dose Trigger Form
1.Select appropriate response -
Will the participant return for
consent/eligibility assessment for
the booster dose visit?
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871330
Page 72 of 171
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871331
Page 73 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871332
Page 74 of 171
***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: 12312893 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: [ ]
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871333
Page 75 of 171
***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: 12312893 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
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871334
Page 76 of 171
***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: 12312893 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
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871335
Page 77 of 171
***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: 12312893 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 Jan-21-2021 00:43:59 (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.
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871336
Page 78 of 171
***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: 12312893 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 Jan-21-2021 00:43:59 (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 Dec-18-2020 10:37:36 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-23-2020 13:49:02 (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.
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871337
Page 79 of 171
***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: 12312893 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-21-2020
15:39:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-21-2020
15:39:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871338
Page 80 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-21-2020
15:39:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obt
ained
Aug/21/2020Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871339
Page 81 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-21-2020 13:31:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12312893Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-21-2020 13:31:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1943Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-21-2020
15:39:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-21-2020
15:39:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A
) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-21-2020
15:39:55
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871340
Page 82 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Buenos Aires
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871341
Page 83 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-21-2020
15:40:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871342
Page 84 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.a
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclu
sion
Num
ber:1
Crite
rion
Desc
ripti
on:Male or female part
icipants between the
ages of 18 and 55 y
ears, inclusive, 65 a
nd 85 years, inclusi
ve, or 18 and 85 yea
rs, inclusive, at rand
omization (depende
nt upon study stage)
Crite
rion
met?
:YES
Crite
rion
ID: (
For
Pfize
r use
only)
:IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871343
Page 85 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Buenos Aires
1.a Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Male or female participants
between the ages of 18 and
55 years, inclusive, 65 and
85 years, inclusive, or 18 a
nd 85 years, inclusive, at ra
ndomization (dependent up
on study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclu
sion
Num
ber:2Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871344
Page 86 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Crite
rion
Descr
iptio
n:Participants who ar
e willing and able t
o comply with all s
cheduled visits, vac
cination plan, labor
atory tests, lifestyle
considerations, and
other study procedu
res
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):IN02A00
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871345
Page 87 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.b Inclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are willin
g and able to comply with
all scheduled visits, vaccin
ation plan, laboratory tests,
lifestyle considerations, an
d other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871346
Page 88 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclu
sion
Num
ber:3
Crite
rion
Desc
riptio
n:Healthy participant
s who are determin
ed by medical histo
ry, physical examin
ation, and clinical j
udgment of the inve
stigator to be eligibl
e for inclusion in th
e study
Crite
rion
met?
:YES
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):IN03A00Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871347
Page 89 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.c Inclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants who ar
e determined by medical hi
story, physical examination
, and clinical judgment of t
he investigator to be eligibl
e for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871348
Page 90 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclu
sion
Num
ber:4
Crite
rion
Descr
iptio
n:Capable of giving p
ersonal signed infor
med consent, which
includes complianc
e with the requirem
ents and restriction
s listed in the ICD a
nd in this protocol
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):IN04A00Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871349
Page 91 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.d Inclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal
signed informed consent, w
hich includes compliance
with the requirements and r
estrictions listed in the ICD
and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871350
Page 92 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usion
Num
ber:1
Crite
rion
Desc
ripti
on:Other medical or ps
ychiatric condition i
ncl. recent (within p
ast year) or active s
uicidal ideation/beh
avior/lab abnormali
ty that may increase
the risk of study par
ticipation
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX01A00Initial Entry
2.a Exclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871351
Page 93 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatri
c condition incl. recent (wit
hin past year) or active suic
idal ideation/behavior/lab a
bnormality that may increa
se the risk of study particip
ationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:2Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871352
Page 94 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criteri
on Des
criptio
n:Known infection
with human immu
nodeficiency virus
(HIV), hepatitis C
virus (HCV), or h
epatitis B virus (H
BV)
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX02A00
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871353
Page 95 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.b Exclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with hum
an immunodeficiency virus
(HIV), hepatitis C virus (H
CV), or hepatitis B virus (
HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871354
Page 96 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion
Num
ber:3
Crite
rion
Descr
iptio
n:History of severe a
dverse reaction ass
ociated with a vacci
ne and/or severe all
ergic reaction (eg, a
naphylaxis) to any
component of the st
udy intervention(s)
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX03A00Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871355
Page 97 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.c Exclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adverse r
eaction associated with a v
accine and/or severe allergi
c reaction (eg, anaphylaxis)
to any component of the st
udy intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871356
Page 98 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:4
Criterion
Descriptio
n:Receipt of me
dications inten
ded to prevent
COVID-19
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX04A00Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871357
Page 99 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.d Exclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of medications inte
nded to prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Exclu8Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (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-2021-5683-0871358
Page 100 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Buenos Aires sion
Num
ber:
Crite
rion
Descr
iption
:Immunocompromi
sed individuals wit
h known or suspect
ed immunodeficien
cy, as determined b
y history and/or lab
oratory/physical ex
amination
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX08A00
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871359
Page 101 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.e Exclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised indi
viduals with known or susp
ected immunodeficiency, a
s determined by history an
d/or laboratory/physical ex
aminationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871360
Page 102 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion
Num
ber:10
Crite
rion
Descr
iption
:Bleeding diathesis
or condition associ
ated with prolonge
d bleeding that wou
ld, in the opinion of
the investigator, co
ntraindicate intram
uscular injection
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX10A00Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871361
Page 103 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.f Exclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condi
tion associated with prolon
ged bleeding that would, in
the opinion of the investiga
tor, contraindicate intramus
cular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871362
Page 104 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:11
Criterion
Descriptio
n:Women who
are pregnant
or breastfeedi
ng
Criterion
met?:NO
Criterion I
D: (For Pfi
zer use onl
y):EX11A00Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871363
Page 105 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.g Exclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are pregnant o
r breastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Exclusion 12Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (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-2021-5683-0871364
Page 106 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Buenos Aires Number:
Criterion
Descriptio
n:Previous vacci
nation with an
y coronavirus
vaccine
Criterion
met?:NO
Criterion
ID: (For P
fizer use o
nly):EX12A00
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871365
Page 107 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.h Exclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with a
ny coronavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Exclusi13Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (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-2021-5683-0871366
Page 108 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Buenos Aires on Nu
mber:
Criteri
on Des
criptio
n:Subjects who rece
ive immunosuppr
essive therapy, su
ch as cytotoxic ag
ents or systemic c
orticosteroids
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX13A01
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871367
Page 109 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.i Exclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immu
nosuppressive therapy, suc
h as cytotoxic agents or sys
temic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-21-2020
15:40:22ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (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-2021-5683-0871368
Page 110 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
(UTC-03:00) City of
Buenos AiresExclu
sion
Num
ber:15
Crite
rion
Descr
iption
:Receipt of blood/pl
asma products or i
mmunoglobulin, fr
om 60 days before
study intervention
administration or pl
anned receipt throu
ghout the study
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX14A01
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871369
Page 111 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.j Exclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma pr
oducts or immunoglobulin,
from 60 days before study i
ntervention administration
or planned receipt througho
ut the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871370
Page 112 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
2.k
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:16
Criter
ion De
scripti
on:Participation in ot
her studies involvi
ng study interventi
on within 28 days
prior to study entr
y and/or during st
udy participation
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX15A01Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871371
Page 113 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.k Exclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other studi
es involving study interven
tion within 28 days prior to
study entry and/or during s
tudy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871372
Page 114 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:17
Criteri
on Des
criptio
n:Previous particip
ation in other stu
dies involving st
udy intervention
containing lipid n
anoparticles
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX16A01Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871373
Page 115 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.l Exclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participation in ot
her studies involving study
intervention containing lipi
d nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-21-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871374
Page 116 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
15:40:22
(UTC-03:00) City of
Buenos AiresExcl
usion
Num
ber:22
Crite
rion
Desc
ripti
on:Investigator site sta
ff or Pfizer employ
ees directly involve
d in the conduct of
the study, site staff
otherwise supervise
d by the investigato
r, and their respecti
ve family members
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX21A01
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0871375
Page 117 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.m Exclusion Number:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfi
zer employees directly inv
olved in the conduct of the
study, site staff otherwise s
upervised by the investigat
or, and their respective fam
ily membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020
15:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871376
Page 118 of 171
***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: 12312893 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-21-2020
15:40:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-21-2020 15:40:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-21-2020
15:40:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871377
Page 119 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.a
Date Location User Value Reason
Aug-21-2020 15:40:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Arterial hype
rtension
Start Date: Jun/6/2003
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-21-2020 15:40:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020
15:40:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Arterial hypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-21-2020
15:40:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jun/6/2003Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871378
Page 120 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.a Ongoing:
Date Location User Value Reason
Aug-21-2020
15:40:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Jan-19-2021 12:01:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:2
Medical History
Term:Polyglob
ulia
Start Date: Mar/1/20
20
Ongoing: YESNew Information
Oct-15-2020 12:17:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Polycyth
emia
Start Date: Mar/1/20
20
Ongoing: YESTranscription
Error
Oct-14-2020 16:02:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Poliglob
ulia
Start Date: Mar/1/2
020
Ongoing: YESInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871379
Page 121 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.b Line/MH Number:
Date Location User Value Reason
Oct-14-2020 16:02:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Jan-19-2021
12:01:33
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
Polyg
lobuli
aNew Information
Oct-20-2020
14:33:08
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Samuel
DychterQuery
2: Clo
sedGPD Clin: Thank
you. Please update
the AE fields once
further information
is known.
Oct-19-2020
16:58:16
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Julieta Gelardi Query
2: An
swere
dNo, the biopsy
result will be
available in 30 days
Oct-15-2020
14:59:11
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has
been closed.
Oct-15-2020
14:21:29
(UTC-03:00)ACV0PFEINFP6000 Samuel
DychterQuery
2: Op
enedGPD Clin: Might
you happen to know
if the etiology of the
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0871380
Page 122 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
City of
Buenos
Airespolycythemia is
known?
Oct-15-2020
12:17:51
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Oct-15-2020
12:17:51
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
Polyc
ythem
iaTranscription Error
Oct-15-2020
03:06:14
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedClarify as follows
POLIGLOBULIA.
Term appears to be
in foreign language
are you reporting
POLYCYTHEMIA?
if so edit as such or
please clarify the
term further. Thank
you.
Oct-14-2020
16:02:25
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
Poligl
obuliaInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-14-2020 16:02:25
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Mar/1/2020Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0871381
Page 123 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Buenos Aires
1.b Ongoing:
Date Location User Value Reason
Oct-14-2020 16:02:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871382
Page 124 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date:
Date Location User Value Reason
Aug-21-2020
15:41:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-21-2020
15:41:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
91.05Initial Entry
3. Unit:
Date Location User Value Reason
Aug-21-2020
15:41:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-21-2020
15:41:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
180.0Initial Entry
5. Unit:
Date Location User Value Reason
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871383
Page 125 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-21-2020
15:41:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-21-2020 15:41:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28.1Initial Entry
7.a
Date Location User Value Reason
Aug-21-2020
15:41:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identif
ier::1
Temperature: 36.1
Temperature
Unit:C
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-21-2020
15:41:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-21-2020
15:41:17
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
36.1Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871384
Page 126 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Buenos Aires
7.a Unit:
Date Location User Value Reason
Aug-21-2020
15:41:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-21-2020
15:41:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871385
Page 127 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-21-2020
15:41:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-21-2020
15:41:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
236432Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871386
Page 128 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 16:34:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 16:34:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 16:35:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 16:34:39
(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-02-2020 16:34:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/21/2020Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871387
Page 129 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a
Date Location User Value Reason
Sep-02-2020 16:35:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ4986Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 16:35:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ4986Initial Entry
5.b
Date Location User Value Reason
Sep-02-2020 16:35:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ4987Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-02-2020 16:35:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ4987Initial Entry
5.c
Date Location User Value Reason
Sep-02-2020 16:35:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHY5T0Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (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-2021-5683-0871388
Page 130 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.c Sample ID
Date Location User Value Reason
Sep-02-2020 16:35:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHY5T0Initial Entry
5.d
Date Location User Value Reason
Sep-02-2020 16:35:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHY5T1Initial Entry
5.d Sample ID
Date Location User Value Reason
Sep-02-2020 16:35:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHY5T1Initial Entry
5.e
Date Location User Value Reason
Sep-02-2020 16:36:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHY5T2Initial Entry
5.e Sample ID
Date Location User Value Reason
Sep-02-2020 16:36:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHY5T2Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (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-2021-5683-0871389
Page 131 of 171
***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: 12312893 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 15:53:58
(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 15:53:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-23-2020
15:54:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-23-2020
15:53:58
(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
15:53:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/21/2020Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871390
Page 132 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a
Date Location User Value Reason
Aug-23-2020
15:54:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHY658Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-23-2020
15:54:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHY658Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871391
Page 133 of 171
***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: 12312893 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-21-2020
15:41:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-21-2020 15:41:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-21-2020 15:41:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-21-2020
15:41:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/21/2020 14:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-21-2020 15:41:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871392
Page 134 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
6. Body Side:
Date Location User Value Reason
Aug-21-2020
15:41:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-21-2020 15:41:42
(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-21-2020 15:41:42
(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-21-2020
15:41:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871393
Page 135 of 171
***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: 12312893 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-21-2020
15:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLEC
TED FOR THIS SUBJECTInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871394
Page 136 of 171
***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: 12312893 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 14:42:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871395
Page 137 of 171
***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: 12312893 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 14:43:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
2.a
Date Location User Value Reason
Sep-11-2020 14:43:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifi
er::1
Temperature: 36.1
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-11-2020 14:43:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-11-2020 14:43:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.1Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871396
Page 138 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.a Unit:
Date Location User Value Reason
Sep-11-2020 14:43:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-11-2020 14:43:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871397
Page 139 of 171
***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: 12312893 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 14:43:10
(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 14:43:10
(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 19:26:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-11-2020 14:43:10
(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 14:43:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/11/2020Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871398
Page 140 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a
Date Location User Value Reason
Sep-11-2020 19:26:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1Y2LInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020 19:26:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1Y2LInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871399
Page 141 of 171
***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: 12312893 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 14:43:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020 14:43:29
(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 14:43:29
(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 14:43:29
(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 14:43:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871400
Page 142 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
6. Body Side:
Date Location User Value Reason
Sep-11-2020 14:43:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-11-2020 14:43:29
(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 14:43:29
(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 14:43:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871401
Page 143 of 171
***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: 12312893 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 12:23:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/9/2020Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871402
Page 144 of 171
***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: 12312893 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 12:23:51
(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 12:23:51
(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 13:50:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-09-2020 12:23:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-09-2020 12:23:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871403
Page 145 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a
Date Location User Value Reason
Oct-09-2020 13:50:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNTMKFInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-09-2020 13:50:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BNTMKFInitial Entry
5.b
Date Location User Value Reason
Oct-09-2020 13:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNTMHGInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-09-2020 13:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BNTMHGInitial Entry
5.c
Date Location User Value Reason
Oct-09-2020 14:18:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BKPDXKInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0871404
Page 146 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.c Sample ID
Date Location User Value Reason
Oct-09-2020 14:18:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BKPDXKInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871405
Page 147 of 171
***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: 12312893 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-11-2020 12:03:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-11-2020 12:03:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-11-2020 12:03:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0871406
Page 148 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-04-2021 15:05:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Deleted The adverse
event 1
polyglobulia
under study
was ruled out.
Oct-14-2020 15:48:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871407
Page 149 of 171
***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: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Date Location User Value Reason
Dec-18-2020 10:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871408
Page 150 of 171
***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, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Oct-14-2020 15:48:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-14-2020 15:48:33
(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
Jan-12-2021
23:43:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 5: Closed Closing query on a deleted
adverse event
Jan-04-2021
15:04:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 4: Closed Response satisfies query
Jan-04-2021
15:03:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 5: Answered The adverse event 1
polyglobulia under study
was ruled out.
Dec-23-2020
21:50:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 5: Reissued:
OpenedClinical As
Polycythemia/Polyglobulia
is in past med Hx (of at
least grade 1), there is no
need for an AE for this
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871409
Page 151 of 171
***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, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
*** THIS REPEATING FORM HAS BEEN DELETED ***
continuing condition,
unless it worsens. A
biopsy can be performed
for care of a past med Hx
condition.
Dec-23-2020
12:32:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 5: Answered Changed Information
Dec-23-2020
12:32:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
polyglobulia under
studyChanged Information
Dec-22-2020
15:53:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 5: Reissued:
OpenedCLINICAL
Polyglobula/Polycythemia
is already reported on
previous medical history
(start date 01Mar20).
Please review for cause to
have a biopsy performed
(worsening polycythemia;
workup for possibly
malignancy; other) and
update report as
appropriate
Dec-21-2020
16:47:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 5: Answered Changed Information
Dec-21-2020
16:47:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 4: Answered Changed Information
Dec-21-2020
16:47:55
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
PolyglobuliaChanged Information
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871410
Page 152 of 171
***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, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
*** THIS REPEATING FORM HAS BEEN DELETED ***
of Buenos Aires
Dec-20-2020
21:49:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 5: Opened Clinical - Per safety
reporting guidelines,
please specify the
condition or symptom as
the event term, rather than
a medical procedure.
Dec-17-2020
15:40:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 4: Opened CLINQUERY: if available,
please provide the results
of the biopsy when
responding to this query.
Dec-15-2020
15:31:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 3: Closed Response satisfies query
Dec-14-2020
18:27:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 3: Answered result of the biopsy its still
not available Thank you
Dec-14-2020
16:43:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 3: Opened CLINQUERY: per
response, "According to
the volunteer, the results
will be available on
December 12th"; please
provide the results of the
biopsy when responding to
this query, if available.
Dec-14-2020
14:39:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 3: Candidate CLINQUERY: per
response, "According to
the volunteer, the results
will be available on
December 12th"; please
provide the results of the
biopsy when responding to
this query, if available.
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (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-2021-5683-0871411
Page 153 of 171
***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, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
*** THIS REPEATING FORM HAS BEEN DELETED ***
Dec-03-2020
12:49:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies query
Dec-03-2020
12:08:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 2: Answered According to the
volunteer, the results will
be available on December
12th. Thank you.
Nov-30-2020
18:14:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 2: Opened CLINQUERY: please
provide the results of the
biopsy, if available. Per
response on 22Oct, the
result of the biopsy will be
in 40 days, approximately.
Oct-22-2020
19:44:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-22-2020
18:15:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Answered The result of the biopsy
will be in 40 days,
approximately. Thank you.
Oct-21-2020
09:05:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Reissued:
OpenedCLINQUERY: please
provide the results of the
biopsy.
Oct-20-2020
19:38:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Answered Study carried out for the
diagnosis of polyglobulia.
thanks
Oct-15-2020
17:43:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINQUERY: for the AE
Spinal Puncture in the
lumbar sacral region,
please clarify the
underlying pathology that
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871412
Page 154 of 171
***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, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
*** THIS REPEATING FORM HAS BEEN DELETED ***
lead to spinal puncture,
and clarify if the event is
considered related to study
treatment.
Oct-14-2020
15:48:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Spinal Puncture in t
he lumbar sacral re
gionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-14-2020 15:48:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/6/2020 10:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-14-2020 15:48:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/6/2020 11:30Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-14-2020 15:48:33
(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
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871413
Page 155 of 171
***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, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
*** THIS REPEATING FORM HAS BEEN DELETED ***
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-14-2020 15:48:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-14-2020 15:48:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-05-2021
08:02:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Jan-04-2021
12:56:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription
Error
Jan-04-2021
12:56:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
NOT RELATED
If Not Related to study tr
eatment(s), this event is
due to:
OTHER
If Other, specify:Transcription
Error
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0871414
Page 156 of 171
***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, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
*** THIS REPEATING FORM HAS BEEN DELETED ***
Unknown
Jan-04-2021
02:33:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened DM: The
response for "Is
this event related
to study
treatment" Is
reported as 'Not
Related', however
response for,
'Please indicate
what this event is
due to' is missing.
Kindly review
and update.
Dec-22-2020
15:47:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Dec-21-2020
16:49:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Dec-21-2020
16:49:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATEDTranscription
Error
Dec-20-2020
21:48:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINICAL -
Please clarify
how the
procedure
Lumbar Puncture
is related to
Vaccine study
drug.
Oct-14-2020
15:48:33ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (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-2021-5683-0871415
Page 157 of 171
***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, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-03:00) City of
Buenos Aires
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-14-2020 15:48:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-14-2020 15:48:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-14-2020 15:48:33
(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
Oct-14-2020 15:48:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-14-2020 15:48:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (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-2021-5683-0871416
Page 158 of 171
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Category:
Date Location User Value Reason
Dec-18-2020 10:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-18-2020 10:37:36
(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
Jan-22-2021 16:08:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Jan-15-2021 10:50:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered New Information
Jan-15-2021 10:50:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Polycythemia veraNew Information
Jan-12-2021 23:40:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened CLINICAL SAE
(06Jan21) reports
that the
myeloproliferative
neoplasm has been
diagnosed as
Polycythemia Vera.
Please consider an
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871417
Page 159 of 171
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
update for event
term, in both AE
CRF and SAE
report.
Dec-23-2020
21:39:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Dec-23-2020
13:46:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered The SAE follow-up
form was sent with
the last complete
blood count on
November 16, 2020
Dec-21-2020
15:52:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened CLNICAL Please
submit hematology
results (CBC/diff)
in this subject with
myeloproliferative
disorder including
polycythemia, to
SAE report
Dec-21-2020
15:51:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Rewording
Dec-20-2020
22:15:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLNICAL Please
submit hematology
results (+/- anemia)
in this subject with
myeloproliferative
disorder, to SAE
report
Dec-18-2020
10:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Myeloproliferative Neopla
smInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (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-2021-5683-0871418
Page 160 of 171
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
4. Start Date Time:
Date Location User Value Reason
Jan-22-2021
16:00:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 6: Closed Response satisfies query
Jan-17-2021
08:04:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 5: Closed Response satisfies query
Jan-15-2021
10:35:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 6: Answered New Information
Jan-15-2021
10:35:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 5: Answered New Information
Jan-15-2021
10:35:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/15/2020 17:00New Information
Jan-13-2021
07:13:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Closed Related clinical query
present
Jan-12-2021
23:50:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 6: Opened CLINICAL Past Med
Hx now includes the
condition Polycythemia
diagnosed on 01Mar20.
Start date in SAE report
for Myeloproliferative
neoplasm is 15DEC20
(release of pathology
report); please review
Start date, harmonize
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (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-2021-5683-0871419
Page 161 of 171
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
reporting & update
where required.
Jan-08-2021
09:21:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 5: Opened SAE RECON:
AER#2020502098 ,onset
date was recorded as
15Dec2020 in Safety
database however,
recorded as 01Mar2020
on AE CRF. Please
confirm correct Onset
Date. If safety update is
required, please submit
a follow-up SAE form.
Dec-27-2020
13:28:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 4: Closed Will await the pending
SAE update referenced
in a different query
Dec-27-2020
13:27:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 4: Reissued:Ope
nedClinical Thank you;
however in the most
recent SAE update
(22Dec20), there is no
ONSET date for event
of myeloproliferative
neoplasm entered in the
SAE event section
Dec-26-2020
11:35:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 4: Answered SAE tracking form sent
on 12/22/2020. Thank
you.
Dec-24-2020
06:40:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Can
didateRelated clinical query
present.
Dec-24-2020
01:52:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies query
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (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-2021-5683-0871420
Page 162 of 171
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Dec-23-2020
21:44:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 4: Opened CLINICAL Please
submit a SAE safety
update to report the
SAE start date, entered
in the Event section for
SAE Myeloprolif
Neoplasm, at 'Onset
Date'
Dec-23-2020
13:45:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 2: Answered I clarify that the SAE
start date is 01Mar2020
Dec-23-2020
13:44:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Answered I clarify that the SAE
start date is 01Mar2020
Dec-20-2020
22:11:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 3: Closed CLINICAL Onset date
is reported as 01Mar20
(start of polycythemia, a
component of this
illness); SAE report has
no date. In vaccine
study, SAE start date is
day event starts; not day
it meets serious criteria
(item 11; SAE
reporting). Please
submit a date
Dec-20-2020
22:02:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 3: Opened CLINICAL - Please
update SAE report Prior
Medical History section
with the subject's
diagnosed Polycythemia
since 01Mar20.
Dec-18-2020
10:37:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For Myeloproliferative
Neoplasm: Start date
01/Mar/2020 is before
V1D1VX1L visit date
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (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-2021-5683-0871421
Page 163 of 171
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
21/Aug/2020. Please
review and update as
appropriate.
Dec-18-2020
10:37:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start date is before
Consent Date 21/Aug
/2020.
Dec-18-2020
10:37:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/1/2020 17:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-18-2020 10:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-18-2020 10:37:36
(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
Jan-22-2021 16:09:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871422
Page 164 of 171
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Jan-15-2021 10:44:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered ON 13JAN2021,
SAE follow up
form was sent with
this information
Jan-12-2021 23:42:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Opened Clinical Thank you;
however SAE
report (06Jan2021)
does NOT include
the past med Hx
condition of
polycythemia (onset
01Mar20) in the
SAE Past Med
History section.
Please update SAE
medical history.
Dec-26-2020
11:38:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered On 03/01/2020
began studies for
polyglobulia under
study and later
arrived with Sme
myeloproliferative
subtype
polycythemia vera.
SAE followup sent.
Thank you.
Dec-23-2020
21:42:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened CLINICAL Please
submit a SAE
safety followup to
report the past
medical condition
of polycythemia
(polyglobulia)
diagnosed
01Mar2020, as
relevant to SAE and
to study eligibility
(ie without recent
malignancy
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871423
Page 165 of 171
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
diagnosis at study
entry).
Dec-22-2020
08:23:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020
10:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Myeloproliferative
Neoplasm:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Dec-18-2020
10:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?
NO
Did this serious event res
ult in death?
NO
Did this serious event re
quire or prolong hospitali
zation?
NO
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871424
Page 166 of 171
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
NO
Is this serious event life t
hreatening?
NO
Other medically importa
nt 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.
Date Location User Value Reason
Dec-18-2020 10:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-18-2020 10:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-18-2020 10:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871425
Page 167 of 171
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-18-2020 10:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-18-2020 10:37:36
(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
Dec-18-2020 10:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-18-2020 10:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871426
Page 168 of 171
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-22-2020 08:23:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2020502098Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0871427
Page 169 of 171
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-11-2020 12:03:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-21-2020 15:41:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-21-2020 15:40:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-02-2021
15:55:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-02-2021
09:55:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Adolfo Gonzalez Query 1: Answered The subject
reported yes by
mistake, there is
no covid-19
illness
Feb-01-2021
17:07:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Illness eDiary:
Subject reported
"Yes" for the
question "Have
you experienced
any of the
following?” for
the COVID-19
symptoms or
diagnosis on
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0871428
Page 170 of 171
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
28JAN2021. But
there is no
COVID Illness
visit reported in
the database.
Please clarify.
Oct-11-2020
12:03:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Initial Entry
Aug-21-2020
15:41:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/21/2020Initial Entry
Aug-21-2020
15:40:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/21/2020Initial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871429
Page 171 of 171
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12312893 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-23-2020
13:48:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2eaa\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0871430