Document text
Page 1 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984967
Page 2 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/19/2020
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984968
Page 3 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11401156]
2.Birth Date: 1946
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:
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0984969
Page 4 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984970
Page 5 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984971
Page 6 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984972
Page 7 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary Artery Bypass Graft]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2012
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Atherosclerotic Cardiovascular Artery Disease]
Start Date: UNK/UNK/2011
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pacemaker]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984973
Page 8 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergy]
Start Date: UNK/UNK/2017
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterol]
Start Date: UNK/UNK/2000
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gout]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984974
Page 9 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
2.Weight: [234.0]
3.Unit: LB
4.Height: [69.7]
5.Unit: in
6.Body Mass Index: [33.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984975
Page 10 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/19/2020
2.Randomization Number: [231891]
3.Randomization Group: [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984976
Page 11 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
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 [BPG5JP]
5.bSample ID [BPG5JR]
5.cSample ID [BPYZNR]
5.dSample ID [BPYZNS]
5.eSample ID [BPYZNT]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984977
Page 12 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
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 [BPYZNL]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984978
Page 13 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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/19/2020 12:55
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
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984979
Page 14 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984980
Page 15 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984981
Page 16 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984982
Page 17 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYZ36]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984983
Page 18 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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/9/2020 13:50
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
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984984
Page 19 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984985
Page 20 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8D8D]
5.bSample ID [BPG5RM]
5.cSample ID [BPG5RN]
5.dSample ID [BPG5RP]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984986
Page 21 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984987
Page 22 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984988
Page 23 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984989
Page 24 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984990
Page 25 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984991
Page 26 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984992
Page 27 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984993
Page 28 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984994
Page 29 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984995
Page 30 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984996
Page 31 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/7/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984997
Page 32 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984998
Page 33 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984999
Page 34 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985000
Page 35 of 147
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Aortic Valve Dysfu
nction Oct/1/2020 UNK:
UNK YES Repeating
Pages
2.ADVERSE EV
ENT 2 pain at injection site
Feb/9/2021 09:00 NO
End Date Time:
Feb/10/2021 11:00
Repeating
Pages
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985001
Page 36 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[Aortic Valve Dysfunction]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
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
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:
[pre-existing medical history]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985002
Page 37 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021131934]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985003
Page 38 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[pain at injection site]
4.Start Date Time: Feb/9/2021 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/10/2021 11:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985004
Page 39 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985005
Page 40 of 147
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985006
Page 41 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985007
Page 42 of 147
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985008
Page 43 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: //
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985009
Page 44 of 147
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985010
Page 45 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985011
Page 46 of 147
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985012
Page 47 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985013
Page 48 of 147
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985014
Page 49 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985015
Page 50 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985016
Page 51 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985017
Page 52 of 147
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985018
Page 53 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985019
Page 54 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985020
Page 55 of 147
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985021
Page 56 of 147
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985022
Page 57 of 147
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985023
Page 58 of 147
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985024
Page 59 of 147
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985025
Page 60 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985026
Page 61 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/8/2021
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985027
Page 62 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985028
Page 63 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death :Feb/8/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985029
Page 64 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
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 [BRFJBY]
5.bSample ID [BSGRC2]
5.cSample ID [BSGRC3]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985030
Page 65 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
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 [BP8DYG]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985031
Page 66 of 147
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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/8/2021 12:15
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
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985032
Page 67 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985033
Page 68 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
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 [BRFJHY]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985034
Page 69 of 147
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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/1/2021 11:57
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
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985035
Page 70 of 147
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985036
Page 71 of 147
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985037
Page 72 of 147
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985038
Page 73 of 147
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985039
Page 74 of 147
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985040
Page 75 of 147
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985041
Page 76 of 147
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985042
Page 77 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/7/2020
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985043
Page 78 of 147
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985044
Page 79 of 147
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Stephen
Thomas Approved Mar-12-2021 15:37:33 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, 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.
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985045
Page 80 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-19-2020 15:44:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985046
Page 81 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormFeb-08-2021 14:38:45 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985047
Page 82 of 147
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Stephen
Thomas Approved Mar-12-2021 15:37:33 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-08-2021 14:36:44 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Thomas Approved Oct-28-2020 14:17:08 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, 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.
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0985048
Page 83 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-19-2020 15:44:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-19-2020 15:44:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985049
Page 84 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-19-2020 15:44:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/19/2020Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985050
Page 85 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-19-2020 15:44:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11401156Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-19-2020 15:44:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1946Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-19-2020 15:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-19-2020 15:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 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-19-2020 15:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985051
Page 86 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-19-2020 15:44:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985052
Page 87 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-19-2020 15:45:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-19-2020 15:45:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-19-2020 15:45:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985053
Page 88 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Aug-19-2020 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:Coronary Artery B
ypass Graft
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/201
2Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-19-2020 15:49:31
(UTC-05:00) Eastern
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-19-2020 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Coronary Artery Bypass GraftInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-19-2020 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-19-2020 15:49:31 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985054
Page 89 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-05:00) Eastern
Time (US & Canada)NO
End Date:
UNK/UNK/2012
1.b
Date Location User Value Reason
Aug-19-2020 15:50:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical Hi
story Term
:Atherosclerotic Cardi
ovascular Artery Dise
ase
Start Date: UNK/UNK/2011
Ongoing: YESInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985055
Page 90 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-19-2020 15:50:09
(UTC-05:00) Eastern
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-19-2020 15:50:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Atherosclerotic Cardiovascular Ar
tery DiseaseInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-19-2020 15:50:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-19-2020 15:50:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-19-2020 15:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History T
erm:Hypertension
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985056
Page 91 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-19-2020 15:50:22
(UTC-05:00) Eastern
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-19-2020 15:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-19-2020 15:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-19-2020 15:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-19-2020 15:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History T
erm:Pacemaker
Start Date: UNK/UNK/2
016
Ongoing: YESInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985057
Page 92 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-19-2020 15:50:45
(UTC-05:00) Eastern
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-19-2020 15:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PacemakerInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-19-2020 15:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-19-2020 15:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-19-2020 15:51:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History T
erm:Seasonal Alle
rgy
Start Date: UNK/UNK/2
017
Ongoing: YESInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985058
Page 93 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-19-2020 15:51:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 15:51:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal AllergyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-19-2020 15:51:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-19-2020 15:51:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-19-2020 15:51:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History T
erm:Hypercholest
erol
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985059
Page 94 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-19-2020 15:51:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 15:51:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypercholesterolInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-19-2020 15:51:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-19-2020 15:51:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-19-2020 15:51:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History T
erm:Gout
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985060
Page 95 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.g Line/MH Number:
Date Location User Value Reason
Aug-19-2020 15:51:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 15:51:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GoutInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-19-2020 15:51:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-19-2020 15:51:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985061
Page 96 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-19-2020 15:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-19-2020 15:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
234.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-19-2020 15:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-19-2020 15:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
69.7Initial Entry
5. Unit:
Date Location User Value Reason
Aug-19-2020 15:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-19-2020 15:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
33.9Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985062
Page 97 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7.a
Date Location User Value Reason
Aug-19-2020 15:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 97.8
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-19-2020 15:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-19-2020 15:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-19-2020 15:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-19-2020 15:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985063
Page 98 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-19-2020 15:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-19-2020 15:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
231891Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985064
Page 99 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 15:53:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 15:53:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-20-2020 10:00:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-19-2020 16:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM Query: 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-19-2020 15:53:09
(UTC-05:00) Eastern
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-19-2020 15:53:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0985065
Page 100 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a
Date Location User Value Reason
Aug-20-2020 10:00:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPG5JPInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-20-2020 10:00:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPG5JPInitial Entry
5.b
Date Location User Value Reason
Aug-20-2020 10:00:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPG5JRInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-20-2020 10:00:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPG5JRInitial Entry
5.c
Date Location User Value Reason
Aug-20-2020 10:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYZNRInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-20-2020 10:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYZNRInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985066
Page 101 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d
Date Location User Value Reason
Aug-20-2020 10:00:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYZNSInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-20-2020 10:00:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYZNSInitial Entry
5.e
Date Location User Value Reason
Aug-20-2020 10:01:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYZNTInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-20-2020 10:01:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYZNTInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985067
Page 102 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 15:53:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 15:53:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-20-2020 10:01:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-19-2020 16:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM Query: 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-19-2020 15:53:15
(UTC-05:00) Eastern
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-19-2020 15:53:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0985068
Page 103 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a
Date Location User Value Reason
Aug-20-2020 10:01:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYZNLInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-20-2020 10:01:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYZNLInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985069
Page 104 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-19-2020 15:54:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-19-2020 15:54:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-19-2020 15:54:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-19-2020 15:54:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020 12:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-19-2020 15:54:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-19-2020 15:54:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985070
Page 105 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Aug-19-2020 15:54:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-19-2020 15:54:08
(UTC-05:00) Eastern
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-19-2020 15:54:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985071
Page 106 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-19-2020 15:54:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985072
Page 107 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-09-2020 16:07:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985073
Page 108 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020 16:08:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2.a
Date Location User Value Reason
Sep-09-2020 16:08:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 97.8
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-09-2020 16:08:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-09-2020 16:08:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-09-2020 16:08:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985074
Page 109 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.a Temperature Location:
Date Location User Value Reason
Sep-09-2020 16:08:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985075
Page 110 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020 16:08:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020 16:08:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020 16:20:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-09-2020 16:08:18
(UTC-05:00) Eastern
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-09-2020 16:08:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-09-2020 16:20:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYZ36Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985076
Page 111 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Sep-09-2020 16:20:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYZ36Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985077
Page 112 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-09-2020 16:08:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-09-2020 16:08:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020 16:08:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-09-2020 16:08:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020 13:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-09-2020 16:08:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-09-2020 16:08:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985078
Page 113 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Sep-09-2020 16:08:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-09-2020 16:08:57
(UTC-05:00) Eastern
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-09-2020 16:08:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985079
Page 114 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 15:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985080
Page 115 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020 15:22:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020 15:22:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020 12:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-08-2020 03:17:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-07-2020 15:22:00
(UTC-05:00) Eastern
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-07-2020 15:22:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985081
Page 116 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Oct-08-2020 12:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8D8DInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-08-2020 12:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8D8DInitial Entry
5.b
Date Location User Value Reason
Oct-08-2020 12:04:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPG5RMInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-08-2020 12:04:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPG5RMInitial Entry
5.c
Date Location User Value Reason
Oct-08-2020 12:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPG5RNInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-08-2020 12:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPG5RNInitial Entry
5.d
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985082
Page 117 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Oct-08-2020 12:04:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPG5RPInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-08-2020 12:04:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPG5RPInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985083
Page 118 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-07-2020 15:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-07-2020 15:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-07-2020 15:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985084
Page 119 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-08-2021 16:22:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985085
Page 120 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-01-2021 15:38:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985086
Page 121 of 147
***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, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
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
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aortic Valve DysfunctionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985087
Page 122 of 147
***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, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
Feb-10-2021 20:19:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Aortic Valve
Dysfunction:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated w
ith congenital anomaly or birth d
efect?
NO
Did this serious event result in d
eath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disability/
incapacity?
NO
Is this serious event life threateniInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985088
Page 123 of 147
***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, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
ng?
NO
Other medically important serio
us 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
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
pre-existing medical historyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985089
Page 124 of 147
***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, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-08-2021 16:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-10-2021 20:19:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021131934Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0985090
Page 125 of 147
***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, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-01-2021 15:38:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-01-2021 15:38:33
(UTC-05:00) Eastern
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
Mar-01-2021 15:38:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
pain at injection siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-01-2021 15:38:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/9/2021 09:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-01-2021 15:38:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/10/2021 11:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985091
Page 126 of 147
***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, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Mar-01-2021 15:38:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 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
Mar-01-2021 15:38:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 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
Mar-04-2021 13:32:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-04-2021 08:19:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Mar-04-2021 08:19:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NONew Information
Mar-01-2021 23:52:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for " Is this adverse
event the result of a
study Medication
Error? If Yes, record
the type of
medication error on
the Medication
Error Log." is
missing. Kindly
review and update.
9. Is this event related to study treatment:
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0985092
Page 127 of 147
***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, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Mar-01-2021 15:38:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-01-2021 15:38:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-01-2021 15:38:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-01-2021 15:38:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-01-2021 15:38:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-01-2021 15:38:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985093
Page 128 of 147
***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, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-11-2021 16:27:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Changed
Information
Mar-11-2021 16:26:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/6/2021Changed
Information
Feb-08-2021 14:37:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/8/2021Transcription Error
Feb-08-2021 14:36:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/4/2021Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985094
Page 129 of 147
***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
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-11-2021 16:27:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per other protocol all
owance(s) and confirmed to h
ave received only placebo at
Vaccination 1/2Changed
Information
Feb-08-2021 14:37:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-08-2021 14:36:53
(UTC-05:00) Eastern
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-08-2021 14:36:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 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
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985095
Page 130 of 147
***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, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Mar-11-2021
22:10:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_36
Mar-11-2021
16:04:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dChanged Information
Mar-11-2021
16:04:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Jan/12
/2021Changed Information
Mar-02-2021
00:30:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM: Date treatment
unblinded should be
after or same REVAX
date when reason is
ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION.
Please verify and
update dates as
appropriate or else
clarify with the
comment. Thank you.
Mar-01-2021
14:28:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dDate entered matches
source
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0985096
Page 131 of 147
***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, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-23-2021
12:08:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7352572;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-08-2021
14:37:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Jan/4/
2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-08-2021 14:37:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0985097
Page 132 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-08-2021 14:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/8/2021Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985098
Page 133 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-08-2021 14:38:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/8/2021Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985099
Page 134 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-08-2021 14:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/8/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-08-2021 14:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-08-2021 14:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985100
Page 135 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-08-2021 14:39:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-08-2021 14:39:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-09-2021 10:01:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-08-2021 14:39:40
(UTC-05:00) Eastern
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-08-2021 14:39:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/8/2021Initial Entry
5.a
Date Location User Value Reason
Feb-09-2021 10:01:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRFJBYInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985101
Page 136 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Feb-09-2021 10:01:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRFJBYInitial Entry
5.b
Date Location User Value Reason
Feb-09-2021 10:01:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSGRC2Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-09-2021 10:01:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSGRC2Initial Entry
5.c
Date Location User Value Reason
Feb-09-2021 10:01:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSGRC3Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-09-2021 10:01:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSGRC3Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985102
Page 137 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-08-2021 14:51:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-08-2021 14:51:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-09-2021 11:59:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-08-2021 14:51:53
(UTC-05:00) Eastern
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-08-2021 14:51:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/8/2021Initial Entry
5.a
Date Location User Value Reason
Feb-09-2021 11:59:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8DYGInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985103
Page 138 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Feb-09-2021 11:59:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8DYGInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985104
Page 139 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-08-2021 14:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-08-2021 14:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-08-2021 14:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-08-2021 14:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/8/2021 12:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-08-2021 14:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-08-2021 14:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985105
Page 140 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Feb-08-2021 14:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-08-2021 14:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-08-2021 14:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-08-2021 14:52:28
(UTC-05:00) Eastern
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-08-2021 14:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985106
Page 141 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-01-2021 15:36:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2021Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985107
Page 142 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-01-2021 15:36:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-01-2021 15:36:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-02-2021 14:37:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-02-2021 04:38:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-01-2021 15:36:36
(UTC-05:00) Eastern
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-01-2021 15:36:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/1/2021Initial Entry
5.a
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985108
Page 143 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Mar-02-2021 14:37:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRFJHYInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-02-2021 14:37:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRFJHYInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985109
Page 144 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-01-2021 15:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-01-2021 15:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-01-2021 15:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-01-2021 15:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2021 11:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-01-2021 15:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-01-2021 15:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985110
Page 145 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Mar-01-2021 15:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-01-2021 15:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-01-2021 15:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-01-2021 15:37:15
(UTC-05:00) Eastern
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-01-2021 15:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985111
Page 146 of 147
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-07-2020 15:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-19-2020 15:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-19-2020 15:45:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-07-2020 15:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
Aug-19-2020 15:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
Aug-19-2020 15:45:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985112
Page 147 of 147
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401156 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-28-2020 13:28:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae30fb\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985113