Document text
Page 1 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021574
Page 2 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/31/2020
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021575
Page 3 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10851216]
2.Birth Date: /1959
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (6)
FDA-CBER-2021-5683-0021576
Page 4 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021577
Page 5 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021578
Page 6 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021579
Page 7 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypothyroidism]
Start Date: UNK/UNK/1990
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benign prostatic hyperplasia]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[vasectomy]
Start Date: UNK/UNK/1996
Ongoing: NO
End Date:
UNK/UNK/1996
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021580
Page 8 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [189.0]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [29.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [96.9] Comments
Unit: F Comments
Temperature Location: ORAL CAVITY Comments
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021581
Page 9 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [247120]
3.Randomization Group: [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021582
Page 10 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BKSR5D]
5.bSample ID [BLD25Y]
5.cSample ID [BLD25Z]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021583
Page 11 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BKSR4W]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021584
Page 12 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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/31/2020 16:23
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021585
Page 13 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021586
Page 14 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021587
Page 15 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021588
Page 16 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9N70]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021589
Page 17 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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/23/2020 16:41
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021590
Page 18 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021591
Page 19 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/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 [BNZKM1]
5.bSample ID [BS7VYM]
5.cSample ID [BS7VYN]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021592
Page 20 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021593
Page 21 of 156
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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: [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021594
Page 22 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021595
Page 23 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021596
Page 24 of 156
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021597
Page 25 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021598
Page 26 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021599
Page 27 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021600
Page 28 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021601
Page 29 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021602
Page 30 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021603
Page 31 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021604
Page 32 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
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FDA-CBER-2021-5683-0021605
Page 33 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021606
Page 34 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Left leg fracture of tibi
a/fibula Oct/17/2020 UNK
:UNK NO
End Date Time:
Oct/18/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Fall in hole Oct/17/2020 UNK
:UNK NO
End Date Time:
Oct/17/2020 UNK:UNK
Repeating
Pages
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021607
Page 35 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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)[Left leg fracture of tibia/fibula]
4.Start Date Time: Oct/17/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/18/2020 UNK:UNK
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).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021608
Page 36 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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:
[STEPPING IN HOLE]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020409576]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021609
Page 37 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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)[Fall in hole]
4.Start Date Time: Oct/17/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/17/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Fall in hole]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021610
Page 38 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021611
Page 39 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021612
Page 40 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021613
Page 41 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021614
Page 42 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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: //
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021615
Page 43 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021616
Page 44 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021617
Page 45 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021618
Page 46 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021619
Page 47 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021620
Page 48 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021621
Page 49 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021622
Page 50 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021623
Page 51 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021624
Page 52 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021625
Page 53 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021626
Page 54 of 156
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/9/2021
2.Erroneous Visit
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021627
Page 55 of 156
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021628
Page 56 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/9/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021629
Page 57 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021630
Page 58 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021631
Page 59 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021632
Page 60 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/12/2021
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021633
Page 61 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021634
Page 62 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death :Feb/12/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021635
Page 63 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6WCV]
5.bSample ID [BLD2CP]
5.cSample ID [BLD2CR]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021636
Page 64 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6WCP]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021637
Page 65 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/12/2021 12:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021638
Page 66 of 156
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021639
Page 67 of 156
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6WH4]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021640
Page 68 of 156
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/3/2021 11:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021641
Page 69 of 156
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021642
Page 70 of 156
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021643
Page 71 of 156
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021644
Page 72 of 156
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021645
Page 73 of 156
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021646
Page 74 of 156
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021647
Page 75 of 156
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021648
Page 76 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/21/2020
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021649
Page 77 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021650
Page 78 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021651
Page 79 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormAug-31-2020 17:40:12 (UTC-06:00) Central
Time (US & Canada)Katherine
Benitez
(pfe kbenitez)Not Applicable
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021652
Page 80 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
7.aSep-01-2020 07:56:52 (UTC-06:00) Central
Time (US & Canada)Angi Cox
(pfe.acox1)NCS
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021653
Page 81 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
7.aSep-01-2020 07:56:52 (UTC-06:00) Central
Time (US & Canada)Angi Cox
(pfe.acox1)NCS
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021654
Page 82 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
7.aSep-01-2020 07:56:52 (UTC-06:00) Central
Time (US & Canada)Angi Cox
(pfe.acox1)NCS
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021655
Page 83 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormFeb-25-2021 08:19:00 (UTC-06:00) Central
Time (US & Canada)Chyann Stewart
(pfe.cstewart)Not Applicable
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021656
Page 84 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Feb-25-2021 08:19:00 (UTC-06:00) Central
Time (US & Canada)Chyann Stewart
(pfe.cstewart)Not Applicable
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021657
Page 85 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormFeb-25-2021 08:21:53 (UTC-06:00) Central
Time (US & Canada)Chyann Stewart
(pfe.cstewart)Not Applicable
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021658
Page 86 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Feb-25-2021 08:21:53 (UTC-06:00) Central
Time (US & Canada)Chyann Stewart
(pfe.cstewart)Not Applicable
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021659
Page 87 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormFeb-12-2021 15:46:24 (UTC-06:00) Central
Time (US & Canada)Katherine
Benitez
(pfe kbenitez)Not Applicable
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021660
Page 88 of 156
***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, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Banika Ervin N/A Feb-12-2021 12:56:19 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gregory Fuller Approved Nov-05-2020 09:25:37 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GregoryFuller, 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.
Katherine
Benitez N/A Oct-30-2020 13:50:04 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gregory Fuller Approved Oct-30-2020 12:42:23 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GregoryFuller, 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.
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021661
Page 89 of 156
***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, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Katherine
Benitez N/A Oct-29-2020 16:06:22 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gregory Fuller Approved Oct-28-2020 19:08:21 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GregoryFuller, 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.
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021662
Page 90 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-31-2020 17:39:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020 17:39:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021663
Page 91 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-31-2020 17:39:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/31/2020Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021664
Page 92 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020 17:38:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10851216Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020 17:38:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1959Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020 17:39:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020 17:39:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-31-2020 17:39:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
WHITEInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (6)
FDA-CBER-2021-5683-0021665
Page 93 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020 17:40:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Aug/31/2020Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021666
Page 94 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-31-2020 17:40:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020 17:40:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020 17:40:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021667
Page 95 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Aug-31-2020 17:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:hypertension
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-31-2020 17:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 17:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
hypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-31-2020 17:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-31-2020 17:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
YESInitial Entry
1.b
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021668
Page 96 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-31-2020 17:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:hypothyroidis
m
Start Date: UNK/UNK/1
990
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-31-2020 17:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 17:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
hypothyroidismInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-31-2020 17:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
UNK/UNK/1990Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-31-2020 17:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-01-2020 07:59:35
(UTC-06:00) CentralACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Line/MH Nu 3Transcription Error
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021669
Page 97 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada) mber:
Medical Histo
ry Term:Benign prostatic
hyperplasia
Start Date: UNK/UNK/2018
Ongoing: YES
Aug-31-2020 17:42:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:Benign prostatic
hyperplasia
Start Date: UNK/UNK/2020
Ongoing: YESInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021670
Page 98 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
1.c Line/MH Number:
Date Location User Value Reason
Aug-31-2020 17:42:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 17:42:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Benign prostatic hyperplasiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-01-2020 07:59:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-01-2020 07:59:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
UNK/UNK/2018Transcription Error
Aug-31-2020 17:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
31/Aug/2020. Please
review and update
as appropriate.
Aug-31-2020 17:42:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
UNK/UNK/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-31-2020 17:42:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021671
Page 99 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Aug-31-2020 17:43:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:vasectomy
Start Date: UNK/UNK/199
6
Ongoing: NO
End Date:
UNK/UNK/
1996Initial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-31-2020 17:43:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 17:43:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
vasectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-31-2020 17:43:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
UNK/UNK/1996Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-31-2020 17:43:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NO
End Date:
UNK/UNK/1996Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021672
Page 100 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 17:44:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020 17:44:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
189.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020 17:44:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-31-2020 17:44:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
67.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-31-2020 17:44:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-31-2020 17:44:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.6Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021673
Page 101 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
7.a
Date Location User Value Reason
Aug-31-2020 17:44:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Record Identifier:
:1
Temperature: 96.9
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 17:44:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-02-2020 05:51:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Pramod
Margaj
(pfemargap03)Query 1: Closed Closed by DM: PM.
Sep-01-2020 07:57:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Query 1: Answered Added into
comments.
Sep-01-2020 05:33:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Pramod
Margaj
(pfemargap03)Query 1: Reissued:Opened DM 1: Thank you
for your response.
Please state if this is
clinically significant
or not.
Aug-31-2020 17:47:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe kbenitez)Query 1: Answered Original value is
correct
Aug-31-2020 17:44:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 96.9 F
is outside of Normal
Range 97 - 99.5 F.
Aug-31-2020 17:44:08
(UTC-06:00) CentralACV0PFEINFP6000 Katherine
BenitezData Entry:
96.9Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021674
Page 102 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada) (pfe kbenitez)
7.a Unit:
Date Location User Value Reason
Aug-31-2020 17:44:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-31-2020 17:44:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021675
Page 103 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-31-2020 17:46:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-31-2020 17:46:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
247120Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021676
Page 104 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 17:47:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 17:47:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 07:56:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-01-2020 05:32:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Pramod
Margaj
(pfemargap03)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-31-2020 17:47:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-31-2020 17:47:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021677
Page 105 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-01-2020 07:56:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BKSR5DInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 07:56:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BKSR5DInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020 07:56:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BLD25YInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020 07:56:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BLD25YInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020 07:56:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BLD25ZInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020 07:56:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BLD25ZInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021678
Page 106 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 17:47:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 17:47:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 07:55:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-01-2020 05:32:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Pramod
Margaj
(pfemargap03)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-31-2020 17:47:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-31-2020 17:47:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021679
Page 107 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-01-2020 07:55:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BKSR4WInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 07:55:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BKSR4WInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021680
Page 108 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020 17:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 17:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 17:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020 17:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Aug/31/2020 16:23Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 17:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020 17:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
LEFTInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021681
Page 109 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
7. Route:
Date Location User Value Reason
Aug-31-2020 17:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020 17:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-31-2020 17:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
YESInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021682
Page 110 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-31-2020 17:49:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021683
Page 111 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-24-2020 09:30:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sep/23/2020Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021684
Page 112 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020 09:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-24-2020 09:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Record Identifier:: 1
Temperature: 98.1
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-24-2020 09:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-24-2020 09:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-24-2020 09:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021685
Page 113 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-24-2020 09:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021686
Page 114 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 07:37:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 07:37:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020 07:37:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 07:37:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-24-2020 07:37:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020 07:37:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BP9N70Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021687
Page 115 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 07:37:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BP9N70Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021688
Page 116 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-24-2020 09:32:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020 09:32:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020 09:32:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-24-2020 09:32:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sep/23/2020 16:41Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020 09:32:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-24-2020 09:32:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
LEFTInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021689
Page 117 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
7. Route:
Date Location User Value Reason
Sep-24-2020 09:32:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-24-2020 09:32:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-24-2020 09:32:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
YESInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021690
Page 118 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-21-2020 09:48:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Oct/21/2020Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021691
Page 119 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 09:48:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 09:48:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 09:48:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 09:48:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-21-2020 09:48:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020 09:48:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BNZKM1Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021692
Page 120 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 09:48:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BNZKM1Initial Entry
5.b
Date Location User Value Reason
Oct-21-2020 09:48:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BS7VYMInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020 09:48:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BS7VYMInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020 09:48:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BS7VYNInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020 09:48:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BS7VYNInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021693
Page 121 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-21-2020 09:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020 09:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020 09:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021694
Page 122 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Oct-21-2020 15:04:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Form Created
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021695
Page 123 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Oct-29-2020 16:06:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Form Created
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021696
Page 124 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-03-2020 18:41:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hao Hu
(pfe huh17)Query 2: Closed Response satisfies
query
Oct-29-2020 16:06:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe kbenitez)Query 2: Answered Changed data per
query
Oct-29-2020 12:07:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ute Frantz
(pfe frantu)Query 1: Closed this should be an
acceptable discrepancy
now between ARGUS
and clinical DB
Oct-27-2020 20:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hao Hu
(pfe huh17)Query 2: Opened Clin: Was this injury
the result of a fall or
trip (involving a hole)?
Per section 8.49.2.2 of
CRF completion
requirements when a
fall results in an injury,
both the injury and the
fall should be recorded
as AEs. Please
evaluate and update as
appropriate
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021697
Page 125 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Oct-27-2020 01:00:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Reissued:Candidate SAE RECON: For
Clinical review
Oct-26-2020 13:29:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe kbenitez)Query 1: Answered Can not split term.
Correct as is
Oct-24-2020 08:10:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Reissued:Opened SAE RECON 1: The
term match in both
database.Howevem,the
term is coding to 2 PTs
in Safety. Please
review and consider to
split the terms and
record as separate
events in AE CRF.
Oct-22-2020 22:29:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Reissued:Candidate SAE RECON: For
clinical review of
coding discrepancy
Oct-22-2020 07:36:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-22-2020 07:36:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Left leg fracture of tibia/fibulaTranscription Error
Oct-22-2020 06:23:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE RECON:
AER#2020409576,the
term in Safety
database was reported
as 'left leg fracture of
tibia/fibula',however
recorded as 'LEFT
LEG Fracture' in AE
CRF. Please confirm
correct term. If safety
update is required,
please submit a follow
up form
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe kbenitez)Data Entry:
LEFT LEG FRACTUREInitial Entry
4. Start Date Time:
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021698
Page 126 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Oct/17/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NO
End Date Time:
Oct/18/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-26-2020 16:57:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Query closed, will
follow for SAE
update with the
requested COVID
test info
Oct-26-2020 15:22:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe kbenitez)Query 2: Answered follow up sae
submitted.
Oct-23-2020 09:55:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical - COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021699
Page 127 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
follow-up SAE form
[#2020409576] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Oct-22-2020 06:19:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE LEFT LEG
FRACTURE:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe kbenitez)Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threate
ning?Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021700
Page 128 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
NO
Other medically important seri
ous event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020 17:20:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Patricia
Banchero
(pfe.banchp)Query 1: Closed per site response.
Oct-26-2020 15:22:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe kbenitez)Query 1: Answered The patient did not
experience a fall and
them broke their leg.
The patient stepped
in a hole which was
unexpected and then
broke their leg.
Oct-23-2020 19:16:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Patricia
Banchero
(pfe.banchp)Query 1: Reissued:Opened GPDCLIN: Thank
you for your
response. Please
reference CRF
completion
requirements section
8.49.2.2 and update
as applicable if the
subject experienced
a fall. Thank you.
Oct-23-2020 15:40:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe kbenitez)Query 1: Answered Patient stepped in a
hole in their
backyard which
resulted in breaking
their leg. It was not
just a fall. cause of
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021701
Page 129 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
the broken leg was
stepping in a large
hole unexpectedly.
Oct-23-2020 08:21:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Patricia
Banchero
(pfe.banchp)Query 1: Reissued:Opened GPDCLIN: Thank
you for our
response. Please
kindly confirm if the
subject experienced
or did not
experience a fall and
update as applicable
per section 8.49.2.2
of CRF completion
requirements.
Otherwise please
clarify. Thank you.
Oct-22-2020 16:17:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Oct-22-2020 16:17:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe kbenitez)Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
STEPPING IN HOLEChanged
Information
Oct-22-2020 15:24:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Patricia
Banchero
(pfe.banchp)Query 1: Opened GPDCLIN: Per CRF
completion
requirements
(8.49.2.2) when a
fall results in an
injury, both the
injury and the fall
should be recorded
as AEs. Please
review and update
as applicable.
Otherwise, please
clarify.
Oct-21-2020 15:33:13 ACV0PFEINFP6000 Katherine Data Entry: Changed
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021702
Page 130 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
(UTC-06:00) Central
Time (US & Canada)Benitez
(pfe kbenitez)NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
FALLInformation
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe kbenitez)Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHERInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-26-2020 16:55:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Oct-26-2020 15:16:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Oct-26-2020 15:16:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
YESChanged
Information
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021703
Page 131 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Oct-23-2020 09:56:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical - SAE
report states surgery
to place
screws/plate was
performed on 18
Oct 2020; please
review and update
non-Drug Treatment
received if
appropriate
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-21-2020 15:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-22-2020 06:19:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020409576Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021704
Page 132 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Oct-29-2020 16:06:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-29-2020 16:06:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-30-2020 13:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Fall in holeChanged
Information
Oct-29-2020 16:06:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
FallInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-29-2020 16:06:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Oct/17/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-29-2020 16:06:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NO
End Date Time:
Oct/17/2020 UNK:UNKInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021705
Page 133 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
6. Toxicity Grade:
Date Location User Value Reason
Oct-29-2020 16:06:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-29-2020 16:06:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)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-29-2020 16:06:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-29-2020 16:06:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe kbenitez)Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Fall in holeInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021706
Page 134 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Oct-29-2020 16:06:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-29-2020 16:06:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-29-2020 16:06:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-29-2020 16:06:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-29-2020 16:06:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NOInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021707
Page 135 of 156
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021 11:37:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Jan/9/2021Transcription Error
Feb-12-2021 12:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Jan/15/2021Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021708
Page 136 of 156
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-25-2021 08:18:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-14-2021 23:53:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Madhan Babu
(pfe.babum05)Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-12-2021 12:56:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-12-2021 12:56:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika Ervin
(pfe.bervin)Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirmed
to have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021709
Page 137 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Mar-10-2021
15:22:02
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_36
Mar-10-2021
11:38:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Query
1: An
swere
dChanged data per
query
Mar-10-2021
05:34:44
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Madhan Babu
(pfe.babum05)Query
1: Rei
ssued:
Opene
dDM: DOV CRF at
Revax Cont is
unfrozen, kindly
review and update.
Mar-09-2021
12:51:36
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Banika Ervin
(pfe.bervin)Query
1: An
swere
dRvax cont page still
needs to be unfrozen
Mar-05-2021
00:10:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query
1: Rei
ssued:
Opene
dDM: Page unfreeze
kindly verify and
consider updating
correct data. Thank
you.
Mar-04-2021
13:43:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Banika Ervin
(pfe.bervin)Query
1: An
swere
dOn site side, revax cont
page is still frozen.
Please unfreeze.
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021710
Page 138 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Mar-01-2021
23:36:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query
1: Rei
ssued:
Opene
dDM: Page unfreeze
kindly verify and
consider updating
correct data. Thank
you.
Mar-01-2021
15:15:02
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Chyann Stewart
(pfe.cstewart)Query
1: An
swere
dPlease unfreeze Revax
Cont so query can be
updated.
Feb-26-2021
17:12:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW7479041;Date
Treatment Unblinded
should be equal to or
after DOV in REVAX
CONTACT visit when
Reason is ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION.Please
review and update as
appropriate.
Feb-25-2021
08:18:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Chyann Stewart
(pfe.cstewart)Data
Entry
:
Jan/9/
2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-25-2021 08:18:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Chyann
Stewart
(pfe.cstewart)Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021711
Page 139 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Feb-25-2021 08:19:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Chyann
Stewart
(pfe.cstewart)Data Entry:
Not ApplicableInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021712
Page 140 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Feb-25-2021 08:21:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Chyann
Stewart
(pfe.cstewart)Data Entry:
Not ApplicableInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021713
Page 141 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-12-2021 15:45:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Feb/12/2021Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021714
Page 142 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-12-2021 15:45:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/12/2021Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021715
Page 143 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-12-2021 15:46:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Feb/12/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-12-2021 15:46:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-12-2021 15:46:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021716
Page 144 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-12-2021 15:47:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-12-2021 15:47:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-03-2021 15:58:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-15-2021 05:54:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-12-2021 15:47:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-12-2021 15:47:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
YES
Date of Collection:
Feb/12/2021Initial Entry
5.a
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021717
Page 145 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Mar-03-2021 15:58:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Linda
Langdon
(pfe.llangdon)Data Entry:
Sample ID: BR6WCVInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-03-2021 15:58:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Linda
Langdon
(pfe.llangdon)Data Entry:
BR6WCVInitial Entry
5.b
Date Location User Value Reason
Mar-03-2021 16:00:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Linda
Langdon
(pfe.llangdon)Data Entry:
Sample ID: BLD2CPInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-03-2021 16:00:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Linda
Langdon
(pfe.llangdon)Data Entry:
BLD2CPInitial Entry
5.c
Date Location User Value Reason
Mar-03-2021 16:00:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Linda
Langdon
(pfe.llangdon)Data Entry:
Sample ID: BLD2CRInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-03-2021 16:00:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Linda
Langdon
(pfe.llangdon)Data Entry:
BLD2CRInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021718
Page 146 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-12-2021 15:47:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-12-2021 15:47:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-03-2021 16:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-15-2021 05:54:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-12-2021 15:47:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-12-2021 15:47:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
YES
Date of Collection:
Feb/12/2021Initial Entry
5.a
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021719
Page 147 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Mar-03-2021 16:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Linda
Langdon
(pfe.llangdon)Data Entry:
Sample ID: BR6WCPInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-03-2021 16:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Linda
Langdon
(pfe.llangdon)Data Entry:
BR6WCPInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021720
Page 148 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-12-2021 15:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-12-2021 15:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-12-2021 15:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-12-2021 15:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Feb/12/2021 12:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-12-2021 15:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-12-2021 15:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
LEFTInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021721
Page 149 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
7. Route:
Date Location User Value Reason
Feb-12-2021 15:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-12-2021 15:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-12-2021 15:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-12-2021 15:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-12-2021 15:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
YESInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021722
Page 150 of 156
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-05-2021 07:57:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Michael
Johnson
(pfe mjohnson3)Data Entry:
Mar/3/2021Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021723
Page 151 of 156
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-05-2021 07:59:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-05-2021 07:59:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-05-2021 08:00:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-05-2021 07:59:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-05-2021 07:59:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Michael
Johnson
(pfe mjohnson3)Data Entry:
YES
Date of Collection:
Mar/3/2021Initial Entry
5.a
Date Location User Value Reason
Mar-05-2021 08:00:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Michael
Johnson
(pfe mjohnson3)Data Entry:
Sample ID: BR6WH4Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021724
Page 152 of 156
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.a Sample ID
Date Location User Value Reason
Mar-05-2021 08:00:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Michael
Johnson
(pfe mjohnson3)Data Entry:
BR6WH4Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021725
Page 153 of 156
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-05-2021 08:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Michael
Johnson
(pfe mjohnson3)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-05-2021 08:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-05-2021 08:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-05-2021 08:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Michael
Johnson
(pfe mjohnson3)Data Entry:
Mar/3/2021 11:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-05-2021 08:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-05-2021 08:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Michael
Johnson
(pfe mjohnson3)Data Entry:
LEFTInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021726
Page 154 of 156
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
7. Route:
Date Location User Value Reason
Mar-05-2021 08:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-05-2021 08:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-05-2021 08:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-05-2021 08:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Mar-05-2021 08:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Michael
Johnson
(pfe mjohnson3)Data Entry:
YESInitial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021727
Page 155 of 156
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-21-2020 09:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-31-2020 17:46:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-31-2020 17:40:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-21-2020 09:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
Aug-31-2020 17:46:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
Aug-31-2020 17:40:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021728
Page 156 of 156
***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, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851216 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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1. Casebook Signature
Date Location User Value Reason
Oct-28-2020 13:42:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
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090177e196ae3d8c\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021729