Document text
Page 1 of 184
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 version08 SEP 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909321
Page 2 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/23/2020
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909322
Page 3 of 184
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Demography
1.Subject ID [10441139]
2.Birth Date: /1985
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:
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909323
Page 4 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909324
Page 5 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909325
Page 6 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/23/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909326
Page 7 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909327
Page 8 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909328
Page 9 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
2.Weight: [147.1]
3.Unit: kg
4.Height: [175.3]
5.Unit: cm
6.Body Mass Index: [47.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909329
Page 10 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/23/2020
2.Randomization Number: [98399]
3.Randomization Group: [ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909330
Page 11 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLB644]
5.bSample ID [BLB637]
5.cSample ID [BN66TG]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909331
Page 12 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN66TY]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909332
Page 13 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/23/2020 18:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909333
Page 14 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909334
Page 15 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909335
Page 16 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909336
Page 17 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
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 [BN66XD]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909337
Page 18 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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: Oct/14/2020 10:23
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909338
Page 19 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909339
Page 20 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW0HK]
5.bSample ID [BRVKRJ]
5.cSample ID [BRVKSD]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909340
Page 21 of 184
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909341
Page 22 of 184
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909342
Page 23 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909343
Page 24 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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: [ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909344
Page 25 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909345
Page 26 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909346
Page 27 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909347
Page 28 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909348
Page 29 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909349
Page 30 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909350
Page 31 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909351
Page 32 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909352
Page 33 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909353
Page 34 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Unplanned Assessments
1.Assessments
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909354
Page 35 of 184
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#CategoryAE Ide
ntifierAdverse E
ventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 chills Oct/15/2020 U
NK:UNK NO
End Date Time:
Oct/15/2020 UNK:
UNK
Repeating
Pages
2.ADVERSE
EVENT 2 fever Oct/15/2020 U
NK:UNK NO
End Date Time:
Oct/16/2020 UNK:
UNK
Repeating
Pages
3.ADVERSE
EVENT 3 injection si
te pain Oct/14/2020 U
NK:UNK NO
End Date Time:
Oct/15/2020 UNK:
UNK
Repeating
Pages
4.ADVERSE
EVENT 4 fatigue Oct/14/2020 1
8:00 NO
End Date Time:
Oct/16/2020 UNK:
UNK
Repeating
Pages
5.ADVERSE
EVENT 5 headache Oct/14/2020 1
8:00 NO
End Date Time:
Oct/16/2020 UNK:
UNKRepeating
Pages
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909355
Page 36 of 184
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#CategoryAE Ide
ntifierAdverse E
ventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
6.ADVERSE
EVENT 6 Angioede
ma face Oct/16/2020 U
NK:UNK NO
End Date Time:
Oct/17/2020 UNK:
UNK
Repeating
Pages
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909356
Page 37 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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)[chills]
4.Start Date Time: Oct/15/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/15/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909357
Page 38 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
12.Was a Non-Drug Treatment
given?NO
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909358
Page 39 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909359
Page 40 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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)[fever]
4.Start Date Time: Oct/15/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/16/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909360
Page 41 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
12.Was a Non-Drug Treatment
given?NO
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909361
Page 42 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909362
Page 43 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[injection site pain]
4.Start Date Time: Oct/14/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/15/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909363
Page 44 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
12.Was a Non-Drug Treatment
given?NO
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909364
Page 45 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909365
Page 46 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[fatigue]
4.Start Date Time: Oct/14/2020 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/16/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909366
Page 47 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
12.Was a Non-Drug Treatment
given?NO
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909367
Page 48 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909368
Page 49 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[headache]
4.Start Date Time: Oct/14/2020 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/16/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909369
Page 50 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
12.Was a Non-Drug Treatment
given?NO
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909370
Page 51 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909371
Page 52 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not
Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Angioedema face]
4.Start Date Time: Oct/16/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/17/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909372
Page 53 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not
Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909373
Page 54 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not
Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909374
Page 55 of 184
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909375
Page 56 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909376
Page 57 of 184
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1.1 VACCINATI
ONS NO Influenza V
accine Nov/9/
2020 Repeating
Pages
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909377
Page 58 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Influenza Vaccine]
5.Date: Nov/9/2020
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909378
Page 59 of 184
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909379
Page 60 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909380
Page 61 of 184
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909381
Page 62 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909382
Page 63 of 184
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909383
Page 64 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909384
Page 65 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/11/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909385
Page 66 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909386
Page 67 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909387
Page 68 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909388
Page 69 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909389
Page 70 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909390
Page 71 of 184
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909391
Page 72 of 184
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909392
Page 73 of 184
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909393
Page 74 of 184
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909394
Page 75 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909395
Page 76 of 184
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909396
Page 77 of 184
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909397
Page 78 of 184
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/8/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909398
Page 79 of 184
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent
Date :Not Applicable
//Comments
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909399
Page 80 of 184
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection /
Notification of Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909400
Page 81 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/11/2020
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909401
Page 82 of 184
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909402
Page 83 of 184
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Aaron
Hartman Approved Mar-03-2021 13:54:16 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AaronHartman, 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.
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909403
Page 84 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormSep-24-2020 07:55:19 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909404
Page 85 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormSep-24-2020 07:56:33 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909405
Page 86 of 184
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormJan-20-2021 08:02:32 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909406
Page 87 of 184
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Jan-20-2021 08:02:32 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909407
Page 88 of 184
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormJan-20-2021 08:02:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909408
Page 89 of 184
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Jan-20-2021 08:02:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909409
Page 90 of 184
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Aaron
Hartman Approved Mar-03-2021 13:54:16 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AaronHartman, 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-16-2021 11:18:38 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Aaron
Hartman Approved Jan-21-2021 16:35:53 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909410
Page 91 of 184
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Affidavit:
By my dated signature below, I, AaronHartman, 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 Jan-20-2021 08:02:00 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Aaron
Hartman Approved Nov-12-2020 17:01:00 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AaronHartman, 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.
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909411
Page 92 of 184
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
N/A Nov-11-2020 09:49:15 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Aaron
Hartman Approved Nov-10-2020 17:21:06 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AaronHartman, 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.
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909412
Page 93 of 184
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-24-2020
07:54:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-24-2020
07:54:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909413
Page 94 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-24-2020
07:54:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Sep/23/2020Initial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909414
Page 95 of 184
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-24-2020
07:54:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10441139Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-24-2020
07:54:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1985Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-24-2020
07:55:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909415
Page 96 of 184
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Sep-24-2020
07:55:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-24-2020
07:55:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909416
Page 97 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-24-2020
07:55:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909417
Page 98 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-24-2020
07:55:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-24-2020
07:55:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-24-2020
07:55:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909418
Page 99 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-24-2020
07:56:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT
known to be HIV P
OSITIVEInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909419
Page 100 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020
08:00:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-25-2020
03:46:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies
query
Sep-24-2020
17:03:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered not clinically
significant
Sep-24-2020
13:33:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:
OpenedPlease
confirm if this
is clinically
significant or
not.
Sep-24-2020 ACV0PFEINFP6000 Query 1: Answered Original
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0909420
Page 101 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
08:00:39
(UTC-05:00)
Eastern Time (US
& Canada)value is
correct
Sep-24-2020
08:00:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Weight 147.1
is outside of
Normal
Range 25 -
136 for kg or
50 - 300 for
lb.
Sep-24-2020
08:00:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
147.1Initial Entry
3. Unit:
Date Location User Value Reason
Sep-24-2020
08:00:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-24-2020
08:00:09
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
175.3Initial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909421
Page 102 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Eastern Time (US
& Canada)
5. Unit:
Date Location User Value Reason
Sep-24-2020
08:00:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-24-2020
08:00:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
47.9Initial Entry
7.a
Date Location User Value Reason
Sep-24-2020
08:00:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Id
entifier::1
Temperat
ure:98.5
Temperat
ure Unit:FInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909422
Page 103 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Temperat
ure Locati
on::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-24-2020
08:00:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-24-2020
08:00:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-24-2020
08:00:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909423
Page 104 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Sep-24-2020
08:00:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909424
Page 105 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-24-2020
07:57:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-24-2020
07:57:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98399Initial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909425
Page 106 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020
07:57:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020
07:57:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-24-2020
07:57:29
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909426
Page 107 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-24-2020
07:57:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020
07:58:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BLB6
44Transcription
Error
Sep-24-2020
07:57:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN66
TZInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020
07:58:44
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
BLB644Transcription
Error
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909427
Page 108 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Eastern Time
(US & Canada)
Sep-24-2020
07:57:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN66TZInitial Entry
5.b
Date Location User Value Reason
Sep-24-2020
07:58:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BLB63
7Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-24-2020
07:58:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLB637Initial Entry
5.c
Date Location User Value Reason
Sep-24-2020
07:59:10
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Sample I BN66TInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909428
Page 109 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Eastern Time (US
& Canada)D: G
5.c Sample ID
Date Location User Value Reason
Sep-24-2020
07:59:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN66TGInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909429
Page 110 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020
07:56:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020
07:56:57
(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-24-2020
07:58:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-24-2020
07:56:57
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909430
Page 111 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-24-2020
07:56:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020
10:30:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN66T
YTranscription
Error
Sep-24-2020
07:58:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN66
TZInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-25-2020
10:30:30
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
BN66TYTranscription
Error
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909431
Page 112 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Eastern Time
(US & Canada)
Sep-24-2020
07:58:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN66TZInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909432
Page 113 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-24-2020
07:56:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020
07:56:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020
07:56:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909433
Page 114 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Sep-24-2020
07:56:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020 18:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020
07:56:16
(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-24-2020
07:56:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-24-2020
07:56:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909434
Page 115 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-24-2020
07:56:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-24-2020
07:56:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909435
Page 116 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-24-2020
07:55:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTED
FOR THIS SUBJE
CTInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909436
Page 117 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020
11:44:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909437
Page 118 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date:
Date Location User Value Reason
Oct-14-2020
11:44:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
2.a
Date Location User Value Reason
Oct-14-2020
11:44:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Id
entifier::1
Temperat
ure:98.9
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-14-2020
11:44:33
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909438
Page 119 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
& Canada)
2.a Temperature:
Date Location User Value Reason
Oct-14-2020
11:44:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.9Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-14-2020
11:44:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-14-2020
11:44:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909439
Page 120 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
11:44:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
11:44:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020
11:45:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-14-2020
11:44:45
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909440
Page 121 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
11:44:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020
11:45:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN66X
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020
11:45:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN66XDInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909441
Page 122 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-14-2020
11:45:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-14-2020
11:45:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-14-2020
11:45:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909442
Page 123 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Oct-14-2020
11:45:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 10:23Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-14-2020
11:45:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-14-2020
11:45:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-14-2020
11:45:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909443
Page 124 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-14-2020
11:45:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-14-2020
11:45:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909444
Page 125 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-11-2020
09:49:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909445
Page 126 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020
09:49:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020
09:49:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-11-2020
09:49:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-11-2020
09:49:38
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909446
Page 127 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-11-2020
09:49:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
Nov-11-2020
09:49:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPW0H
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-11-2020
09:49:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPW0HKInitial Entry
5.b
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909447
Page 128 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Nov-11-2020
09:50:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRVK
RJInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-11-2020
09:50:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRVKRJInitial Entry
5.c
Date Location User Value Reason
Nov-11-2020
09:50:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRVKS
DInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909448
Page 129 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.c Sample ID
Date Location User Value Reason
Nov-11-2020
09:50:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRVKSDInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909449
Page 130 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Date Location User Value Reason
Oct-17-2020
11:00:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909450
Page 131 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Date Location User Value Reason
Oct-17-2020
11:01:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909451
Page 132 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Date Location User Value Reason
Oct-17-2020
11:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909452
Page 133 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Date Location User Value Reason
Nov-11-2020
09:53:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909453
Page 134 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Date Location User Value Reason
Nov-11-2020
09:54:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909454
Page 135 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Date Location User Value Reason
Nov-11-2020
09:56:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909455
Page 136 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Category:
Date Location User Value Reason
Oct-17-2020
11:00:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-17-2020
11:00:48
(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
Oct-17-2020
11:00:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
chillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909456
Page 137 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Oct-17-2020
11:00:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-17-2020
11:00:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/15/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-17-2020
11:00:48
(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).
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909457
Page 138 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Oct-17-2020
11:00:48
(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
Oct-17-2020
11:00:48
(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
Oct-17-2020
11:00:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-17-2020
11:00:48
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909458
Page 139 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Eastern Time (US
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-17-2020
11:00:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-17-2020
11:00:48
(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
Oct-17-2020
11:00:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909459
Page 140 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Oct-17-2020
11:00:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909460
Page 141 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Category:
Date Location User Value Reason
Oct-17-2020
11:01:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-17-2020
11:01:32
(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
Oct-17-2020
11:01:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
feverInitial Entry
4. Start Date Time:
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909461
Page 142 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Oct-17-2020
11:01:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-11-2020
09:57:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/16/2020 U
NK:UNKTranscription
Error
Oct-21-2020
10:22:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-19-2020
10:35:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answere
dwill be updated
when subject
presents for
visit 3
Oct-17-2020
13:08:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Please confirm
if event has
resolved?
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (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-2021-5683-0909462
Page 143 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Oct-17-2020
11:01:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-17-2020
11:01:32
(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
Oct-17-2020
11:01:32
(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.
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909463
Page 144 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Oct-17-2020
11:01:32
(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
Oct-17-2020
11:01:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-17-2020
11:01:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-17-2020
11:01:32
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909464
Page 145 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
& Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-17-2020
11:01:32
(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
Nov-11-2020
09:58:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Clo
sedClose Auto Query
Nov-11-2020
09:58:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERE
D/RESOLV
EDChanged Information
Nov-11-2020
09:57:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Op
enedFor AE fever:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909465
Page 146 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Oct-17-2020
11:01:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERI
NG/RESOL
VINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-17-2020
11:01:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909466
Page 147 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Category:
Date Location User Value Reason
Oct-17-2020
11:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-17-2020
11:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-17-2020
11:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
injection site painInitial Entry
4. Start Date Time:
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909467
Page 148 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Oct-20-2020
08:16:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-19-2020
07:57:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answer
edafter
vaccination
Oct-19-2020
02:24:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissue
d:OpenedDM: Thank you
for the response.
Vaccination date
is same as event
date. Please
confirm if event
occur prior to
vaccination or
after the
vaccination.
Else clarify.
Oct-17-2020
18:00:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answer
edOriginal value
is correct
Oct-17-2020
13:09:56
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Query 1: Reissue
d:OpenedPlease confirm
if start time
should be the
same as IP
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (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-2021-5683-0909468
Page 149 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(US & Canada) administration?
Oct-17-2020
11:02:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answer
edOriginal value
is correct
Oct-17-2020
11:02:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE
injection site
pain: Start Date
is the same as a
Vaccination
Date, but time is
not provided.
Please review
and update as
appropriate.
Oct-17-2020
11:02:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 UN
K:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-11-2020
09:58:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/15/2020 U
NK:UNKChanged
Information
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909469
Page 150 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Oct-21-2020
10:24:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-19-2020
10:35:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answere
dwill be
updated when
subject
presents for
visit 3
Oct-17-2020
13:08:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Please confirm
if event has
resolved?
Oct-17-2020
11:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-17-2020
11:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (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-2021-5683-0909470
Page 151 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-17-2020
11:02:25
(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
Oct-17-2020
11:02:25
(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
Oct-17-2020
11:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909471
Page 152 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-17-2020
11:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-17-2020
11:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-17-2020
11:02:25
(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
Nov-11-2020
09:59:00ACV0PFEINFP6000 auto query
(autoquery)Query 1: Clo
sedClose Auto Query
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909472
Page 153 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(UTC-05:00)
Eastern Time
(US & Canada)
Nov-11-2020
09:59:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERE
D/RESOLV
EDChanged Information
Nov-11-2020
09:58:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Op
enedFor AE injection site
pain: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-17-2020
11:02:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERI
NG/RESOL
VINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-17-2020
11:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909473
Page 154 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Category:
Date Location User Value Reason
Nov-11-2020
09:53:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-11-2020
09:53:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-11-2020
09:53:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
fatigueInitial Entry
4. Start Date Time:
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909474
Page 155 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Nov-12-2020
01:20:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
updated.
Nov-11-2020
15:07:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dAnswer Auto
Query
Nov-11-2020
15:07:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 18:00Changed
Information
Nov-11-2020
14:19:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued
:OpenedDM: Thank
you for
response,
however
please provide
a approximate
time for after
vaccination.
Nov-11-2020
09:53:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answere
dafter
vaccination
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909475
Page 156 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Nov-11-2020
09:53:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE
fatigue: Start
Date is the
same as a
Vaccination
Date, but time
is not
provided.
Please review
and update as
appropriate.
Nov-11-2020
09:53:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 UNK
:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-11-2020
09:53:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/16/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-11-2020
09:53:03ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909476
Page 157 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(UTC-05:00)
Eastern Time (US
& Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-11-2020
09:53:03
(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
Nov-11-2020
09:53:03
(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
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909477
Page 158 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Nov-11-2020
09:53:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-11-2020
09:53:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-11-2020
09:53:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-11-2020
09:53:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909478
Page 159 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-11-2020
09:53:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-11-2020
09:53:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909479
Page 160 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Category:
Date Location User Value Reason
Nov-11-2020
09:54:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-11-2020
09:54:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-11-2020
09:54:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
headacheInitial Entry
4. Start Date Time:
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909480
Page 161 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Nov-12-2020
01:20:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
updated.
Nov-11-2020
15:07:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dAnswer Auto
Query
Nov-11-2020
15:07:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 18:00New
Information
Nov-11-2020
14:19:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued
:OpenedDM: Thank
you for
response,
however
please provide
a approximate
time for after
vaccination.
Nov-11-2020
09:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answere
dafter
vaccination
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909481
Page 162 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Nov-11-2020
09:54:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE
headache:
Start Date is
the same as a
Vaccination
Date, but time
is not
provided.
Please review
and update as
appropriate.
Nov-11-2020
09:54:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 UNK
:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-11-2020
09:54:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/16/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-11-2020
09:54:44ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909482
Page 163 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(UTC-05:00)
Eastern Time (US
& Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-11-2020
09:54:44
(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
Nov-11-2020
09:54:44
(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
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909483
Page 164 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Nov-11-2020
09:54:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-11-2020
09:55:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-11-2020
09:54:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-11-2020
09:54:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909484
Page 165 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-11-2020
09:54:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-11-2020
09:54:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909485
Page 166 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not
Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Category:
Date Location User Value Reason
Nov-11-2020
09:56:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-11-2020
09:56:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-14-2020
08:02:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-13-2020 ACV0PFEINFP6000 Query 2: Closed Response
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0909486
Page 167 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not
Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
14:11:38
(UTC-05:00)
Eastern Time
(US & Canada)satisfies query
Nov-13-2020
13:36:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answe
redunknown
Nov-13-2020
10:35:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opene
dclinical: Pls
advise if AE is
considered an
allergic reaction,
and if so pls add
separate AE of
allergic reaction
on CRF. Thanks
Nov-12-2020
16:52:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answe
redNew Information
Nov-12-2020
16:52:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Angioedema fac
eNew Information
Nov-12-2020
15:58:07
(UTC-05:00)ACV0PFEINFP6000 Query 1: Opene
dClinQuery:Please
specify location
of AE in the
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (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-2021-5683-0909487
Page 168 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not
Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Eastern Time
(US & Canada)verbatim term.
Thank you.
Nov-11-2020
09:56:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
AngioedemaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-11-2020
09:56:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/16/2020 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-11-2020
09:56:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/17/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909488
Page 169 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not
Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Nov-11-2020
09:56:21
(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
Nov-11-2020
09:56:21
(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
Nov-11-2020
09:56:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909489
Page 170 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not
Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-11-2020
09:56:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-11-2020
09:56:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-11-2020
09:56:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909490
Page 171 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not
Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Nov-11-2020
09:56:21
(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
Nov-11-2020
09:56:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-11-2020
09:56:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909491
Page 172 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Date Location User Value Reason
Nov-12-2020
14:51:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909492
Page 173 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-12-2020
14:51:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-12-2020
14:51:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-12-2020
14:51:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
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
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909493
Page 174 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Nov-12-2020
15:34:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-12-2020
14:51:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dInitial Entry
Nov-12-2020
14:51:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Influenza VaccineInitial Entry
Nov-12-2020
14:46:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Per Source
subject
reported
receiving the
Influenza Vax
on 9Nov2020.
Please review
and reconcile.
5. Date:
Date Location User Value Reason
Nov-12-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0909494
Page 175 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
14:51:06
(UTC-05:00)
Eastern Time (US
& Canada)Nov/9/2020
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0909495
Page 176 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-11-2020
09:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-11-2020
09:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-11-2020
09:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909496
Page 177 of 184
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-20-2021
08:02:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2021Initial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909497
Page 178 of 184
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-16-2021
11:18:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible and N
OT confirmed t
o have received
only placebo at
Vaccination 1/2Transcription
Error
Jan-20-2021
08:02:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT
willing to return f
or Vaccination 3 O
R otherwise not el
igibleInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909498
Page 179 of 184
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-20-2021
08:02:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-20-2021
08:02:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBIL
ITY FOR ADDITI
ONAL VACCINAT
IONInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909499
Page 180 of 184
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Jan-20-2021
08:02:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909500
Page 181 of 184
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Jan-20-2021
08:02:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909501
Page 182 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-11-2020
09:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-24-2020
07:57:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-24-2020
07:55:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-11-2020
09:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/11/2020Initial Entry
Sep-24-2020
07:57:18ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/23/2020Initial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909502
Page 183 of 184
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(UTC-05:00)
Eastern Time (US
& Canada)
Sep-24-2020
07:55:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/23/2020Initial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909503
Page 184 of 184
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441139 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020
14:36:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to Enabl
eInitial Entry
090177e196d89032\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909504