125742 S1 M5 CRF c4591001 1254 12541006

Document text

Page 1 of 166
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834449
Page 2 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/26/2020
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834450
Page 3 of 166
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12541006]
2.Birth Date: 1961
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:
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834451
Page 4 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834452
Page 5 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834453
Page 6 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/26/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834454
Page 7 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hypertension]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hypercholesterolemia]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Gastroesophageal reflux disease]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834455
Page 8 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Benign prostatic hyperplasia]
Start Date: UNK/UNK/2018
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[mole]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[diabetes mellitus Type 2]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834456
Page 9 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[RIGHT CATARACT]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
Jul/21/2020
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[RIGHT CATARACT SURGERY]
Start Date: Jul/21/2020
Ongoing: NO
End Date:
Jul/21/2020
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[MOLE REMOVAL]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834457
Page 10 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[penicillin drug allergy]
Start Date: UNK/UNK/1968
Ongoing: YES
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834458
Page 11 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
2.Weight: [248.0]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [38.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.0]
Unit: C
Temperature Location: EAR
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834459
Page 12 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/26/2020
2.Randomization Number: [241491]
3.Randomization Group: [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834460
Page 13 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BP8JLB]
5.bSample ID [BP8JLC]
5.cSample ID [BP8JLD]
5.dSample ID [BLG7XB]
5.eSample ID [BLG7XC]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834461
Page 14 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BP8JL9]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834462
Page 15 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/26/2020 13:55
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
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834463
Page 16 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834464
Page 17 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834465
Page 18 of 166
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: EAR
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834466
Page 19 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/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 [BP8K20]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834467
Page 20 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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/14/2020 12:49
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
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834468
Page 21 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834469
Page 22 of 166
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
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 [BLG89J]
5.bSample ID [BLG89K]
5.cSample ID [BR9XN4]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834470
Page 23 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834471
Page 24 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834472
Page 25 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834473
Page 26 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834474
Page 27 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834475
Page 28 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834476
Page 29 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834477
Page 30 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834478
Page 31 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834479
Page 32 of 166
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834480
Page 33 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834481
Page 34 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834482
Page 35 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834483
Page 36 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834484
Page 37 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still
ongoing?
6.Toxicity Grade:
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).
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834485
Page 38 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with
Study Treatment:
11.Was a Concomitant
Medication given?
12.Was a Non-Drug Treatment
given?
13.What was the outcome of
this adverse event?:
14.Did the adverse event cause
the subject to be
discontinued from the
study?
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834486
Page 39 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834487
Page 40 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834488
Page 41 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834489
Page 42 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834490
Page 43 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834491
Page 44 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834492
Page 45 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834493
Page 46 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834494
Page 47 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834495
Page 48 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834496
Page 49 of 166
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834497
Page 50 of 166
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834498
Page 51 of 166
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834499
Page 52 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834500
Page 53 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834501
Page 54 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/23/2021
2.Erroneous Visit
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834502
Page 55 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834503
Page 56 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/23/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834504
Page 57 of 166
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834505
Page 58 of 166
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834506
Page 59 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834507
Page 60 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/26/2021
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834508
Page 61 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834509
Page 62 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/26/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834510
Page 63 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN9V3R]
5.bSample ID [BS682Z]
5.cSample ID [BS6830]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834511
Page 64 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN9V3N]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834512
Page 65 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/26/2021 14:39
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834513
Page 66 of 166
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834514
Page 67 of 166
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/16/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCM8M]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834515
Page 68 of 166
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/16/2021 14:39
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834516
Page 69 of 166
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834517
Page 70 of 166
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834518
Page 71 of 166
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834519
Page 72 of 166
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834520
Page 73 of 166
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834521
Page 74 of 166
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834522
Page 75 of 166
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834523
Page 76 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/14/2020
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834524
Page 77 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834525
Page 78 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert
Heller Approved Mar-09-2021 13:45:17 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertHeller, 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.
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834526
Page 79 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormAug-26-2020 17:46:02 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834527
Page 80 of 166
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-26-2021 17:38:48
(UTC-08:00) Pacific Time (US &
Canada)Not Applicable
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834528
Page 81 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert
Heller Approved Mar-09-2021 13:45:17 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertHeller, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Nov-19-2020 17:31:52 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Heller Approved Oct-21-2020 22:57:03 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834529
Page 82 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
By my dated signature below, I, RobertHeller, 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.
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834530
Page 83 of 166
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-26-2020
17:28:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-26-2020
17:28:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834531
Page 84 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-26-2020
17:28:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Aug/26/2020Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834532
Page 85 of 166
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-26-2020
16:55:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12541006Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-26-2020
16:55:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1961Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-26-2020
17:31:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834533
Page 86 of 166
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Aug-26-2020
17:30:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORIG
INInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-26-2020
17:30:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834534
Page 87 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-26-2020
17:32:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834535
Page 88 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-26-2020
17:46:46
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-26-2020
17:46:46
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-26-2020
17:46:46
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834536
Page 89 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Aug-26-2020
17:49:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:hyperten
sion
Start Date: UNK/U
NK/201
7
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-26-2020
17:49:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
17:49:23
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  Data Entry:
hypertensionInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834537
Page 90 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-26-2020
17:49:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-26-2020
17:49:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-26-2020
17:50:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:hyperchol
esterolem
ia
Start Date
:UNK/UN
K/2017
Ongoing: YESInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834538
Page 91 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Aug-26-2020
17:50:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
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1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
17:50:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
hypercholesterolemi
aInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-26-2020
17:50:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-26-2020
17:50:18ACV0PFEINFP6000  Data Entry:
YESInitial Entry
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(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-0834539
Page 92 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
1.c
Date Location User Value Reason
Aug-26-2020
18:01:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
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H Num
ber:3
Medica
l Histor
y Term
:Gastroes
ophageal
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ate:UNK/UN
K/2010
Ongoin
g:YESTranscription
Error
Aug-26-2020
17:51:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
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Number:3
Medical
History T
erm:GERD
Start Dat
e:UNK/
UNK/2
010
Ongoing: YESInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
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(6)
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FDA-CBER-2021-5683-0834540
Page 93 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c Line/MH Number:
Date Location User Value Reason
Aug-26-2020
17:51:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
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1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
18:01:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Gastroesophageal r
eflux diseaseTranscription
Error
Aug-26-2020
17:51:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
GERDInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-26-2020
17:51:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834541
Page 94 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c Ongoing:
Date Location User Value Reason
Aug-26-2020
17:51:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-26-2020
17:53:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:Benign pro
static hyper
plasia
Start Dat
e:UNK/UNK
/2018
Ongoing: YESInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834542
Page 95 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d Line/MH Number:
Date Location User Value Reason
Aug-26-2020
17:53:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
17:53:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Benign prostatic hyp
erplasiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-26-2020
17:53:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-26-2020
17:53:00ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834543
Page 96 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
1.e
Date Location User Value Reason
Aug-26-2020
17:54:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical H
istory Ter
m:mole
Start Date
:UNK/UN
K/2005
Ongoing: NO
End Date
:
UNK/U
NK/200
5Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834544
Page 97 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Line/MH Number:
Date Location User Value Reason
Aug-26-2020
17:54:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
17:54:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
moleInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-26-2020
17:54:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-26-2020
17:54:01ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834545
Page 98 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/2005
1.f
Date Location User Value Reason
Aug-26-2020
17:56:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical H
istory Ter
m:diabetes m
ellitus Typ
e 2
Start Date
:UNK/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834546
Page 99 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.f Line/MH Number:
Date Location User Value Reason
Aug-26-2020
17:56:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
17:56:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
diabetes mellitus Ty
pe 2Initial Entry
1.f Start Date:
Date Location User Value Reason
Aug-26-2020
17:56:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-26-2020
17:56:21ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834547
Page 100 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
1.g
Date Location User Value Reason
Aug-26-2020
17:58:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical H
istory Ter
m:RIGHT C
ATARAC
T
Start Date
:UNK/UN
K/2017
Ongoing: NO
End Date
:
Jul/21/2
020Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834548
Page 101 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.g Line/MH Number:
Date Location User Value Reason
Aug-26-2020
17:58:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
17:58:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHT CATARAC
TInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-26-2020
17:58:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-26-2020
17:58:19ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834549
Page 102 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
Jul/21/2020
1.h
Date Location User Value Reason
Aug-26-2020
17:59:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:8
Medical
History
Term:RIGHT CAT
ARACT SU
RGERY
Start Da
te:Jul/21/2020
Ongoing
:NO
End Date:
Jul/21/20
20Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834550
Page 103 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.h Line/MH Number:
Date Location User Value Reason
Aug-26-2020
17:59:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
17:59:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHT CATARAC
T SURGERYInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-26-2020
17:59:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jul/21/2020Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-26-2020
17:59:28ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834551
Page 104 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
Jul/21/2020
1.i
Date Location User Value Reason
Aug-26-2020
18:00:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:9
Medical H
istory Ter
m:MOLE RE
MOVAL
Start Date
:UNK/UN
K/2005
Ongoing: NO
End Date
:
UNK/U
NK/200
5Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834552
Page 105 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.i Line/MH Number:
Date Location User Value Reason
Aug-26-2020
18:00:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
18:00:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MOLE REMOVALInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-26-2020
18:00:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-26-2020
18:00:21ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834553
Page 106 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/2005
1.j
Date Location User Value Reason
Aug-28-2020
14:42:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:10
Medical H
istory Ter
m:penicillin
drug aller
gy
Start Date
:UNK/UN
K/1968
Ongoing: YESInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834554
Page 107 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.j Line/MH Number:
Date Location User Value Reason
Aug-28-2020
14:42:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
14:42:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
penicillin drug allerg
yInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834555
Page 108 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.j Start Date:
Date Location User Value Reason
Aug-28-2020
14:42:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1968Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-28-2020
14:42:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-0834556
Page 109 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Aug-26-2020
18:04:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-26-2020
18:04:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
248.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-26-2020
18:04:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834557
Page 110 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Aug-26-2020
18:04:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
67.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-26-2020
18:04:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-26-2020
18:04:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
38.8Initial Entry
7.a
Date Location User Value Reason
Aug-26-2020
18:04:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Identif
ier::1
Temperature: 36.
0Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834558
Page 111 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Temperature
Unit:C
Temperature
Location::EA
R
7.a Record Identifier:
Date Location User Value Reason
Aug-26-2020
18:04:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020
01:41:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Aug-27-2020
13:56:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Original value
is correct
Aug-26-2020
18:04:47
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature
36 C is outside
of Normal
Range 36.1 -
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834559
Page 112 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada) 37.5 C.
Aug-26-2020
18:04:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-26-2020
18:04:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-26-2020
18:04:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834560
Page 113 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-26-2020
18:05:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-26-2020
18:05:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
241491Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834561
Page 114 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020
18:06:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020
18:06:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020
18:06:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-26-2020
18:06:32
(UTC-08:00)ACV0PFEINFP6000  Data Entry:
YES
Date of CollectioTranscription
Error
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834562
Page 115 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)n:
Aug/26/2020
Aug-26-2020
18:06:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-26-2020
18:06:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
5.a
Date Location User Value Reason
Aug-26-2020
18:06:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP8JL
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020
18:06:57
(UTC-08:00)ACV0PFEINFP6000  Data Entry:
BP8JLBInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834563
Page 116 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)
5.b
Date Location User Value Reason
Aug-26-2020
18:07:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP8JL
CInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-26-2020
18:07:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8JLCInitial Entry
5.c
Date Location User Value Reason
Aug-26-2020
18:08:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP8JL
DInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834564
Page 117 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Sample ID
Date Location User Value Reason
Aug-26-2020
18:08:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8JLDInitial Entry
5.d
Date Location User Value Reason
Sep-10-2020
16:50:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BLG7X
BInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-10-2020
16:50:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLG7XBInitial Entry
5.e
Date Location User Value Reason
Sep-10-2020
16:50:44ACV0PFEINFP6000  Data Entry:
Sample I BLG7XInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834565
Page 118 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)D: C
5.e Sample ID
Date Location User Value Reason
Sep-10-2020
16:50:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLG7XCInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834566
Page 119 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020
18:08:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020
18:08:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020
18:08:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-26-2020
18:08:24
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834567
Page 120 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-26-2020
18:08:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020
18:08:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP8JL
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020
18:08:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8JL9Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834568
Page 121 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-26-2020
18:09:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-26-2020
18:09:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020
18:09:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834569
Page 122 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Aug-26-2020
18:09:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020 13:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020
18:09:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-26-2020
18:09:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-26-2020
18:09:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834570
Page 123 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-26-2020
18:09:53
(UTC-08:00)
Pacific 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
Aug-26-2020
18:09:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834571
Page 124 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-07-2020
02:19:23
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Clos
edResponse satisfies
query
Sep-03-2020
10:25:12
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredTranscription Error
Sep-03-2020
10:25:12
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACT
OGENICITY
E-DIARY NO
T COLLECT
ED FOR THI
S SUBJECTTranscription Error
Sep-03-2020
05:17:09
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Open
edeDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'Yes' however VAX 1
eDiary records are
not available for the
subject. Please verify
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834572
Page 125 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
and update. Else,
confirm in query
response
appropriately.
Aug-26-2020
18:10:04
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REAC
TOGENICIT
Y E-DIARY C
OLLECTED
FOR THIS SU
BJECTInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834573
Page 126 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-14-2020
14:45:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834574
Page 127 of 166
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-14-2020
14:46:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2.a
Date Location User Value Reason
Sep-14-2020
14:46:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Identif
ier::1
Temperature: 36.
6
Temperature
Unit:C
Temperature L
ocation::EA
RInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-14-2020
14:46:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834575
Page 128 of 166
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.a Temperature:
Date Location User Value Reason
Sep-14-2020
14:46:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-14-2020
14:46:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-14-2020
14:46:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834576
Page 129 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-14-2020
16:58:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-14-2020
16:58:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020
16:58:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-14-2020
16:58:10
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834577
Page 130 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-14-2020
16:58:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020
16:58:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP8K2
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-14-2020
16:58:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8K20Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834578
Page 131 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-14-2020
14:48:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-14-2020
14:48:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-14-2020
14:48:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834579
Page 132 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-14-2020
14:48:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020 12:49Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-14-2020
14:48:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-14-2020
14:48:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-14-2020
14:48:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834580
Page 133 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-14-2020
14:48:19
(UTC-08:00)
Pacific 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-14-2020
14:48:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834581
Page 134 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-21-2020
15:39:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-20-2020
17:41:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered updated
Oct-19-2020
03:48:46
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM: Patient
completed the
treatment
phase and
reached at
Visit 3.
Kindly
consider to
update EOT
form with
matching V3
date or else
clarify. Thank
you.
Oct-15-2020
13:37:03
(UTC-08:00)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834582
Page 135 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834583
Page 136 of 166
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020
11:38:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020
11:38:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
11:39:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-15-2020
11:38:53
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834584
Page 137 of 166
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-15-2020
11:38:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020
11:39:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BLG89
JInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020
11:39:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLG89JInitial Entry
5.b
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834585
Page 138 of 166
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-15-2020
11:39:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BLG89
KInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020
11:39:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLG89KInitial Entry
5.c
Date Location User Value Reason
Nov-19-2020
17:31:52
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR9XN
4Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834586
Page 139 of 166
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Sample ID
Date Location User Value Reason
Nov-19-2020
17:31:52
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR9XN4Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834587
Page 140 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-20-2020
17:41:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-20-2020
17:41:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-20-2020
17:41:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834588
Page 141 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-26-2021
17:37:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/23/2021Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834589
Page 142 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-26-2021
17:38:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible per loca
l/national reco
mmendations a
nd confirmed to
have received o
nly placebo at V
accination 1/2Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834590
Page 143 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-26-2021
17:38:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/23/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-26-2021
17:38:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBI
LITY FOR ADDI
TIONAL VACCIN
ATIONInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834591
Page 144 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-26-2021
17:38:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/26/2021Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834592
Page 145 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-26-2021
17:38:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Con
sent Obtained
Jan/26/2021Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834593
Page 146 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-26-2021
17:39:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/26/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-26-2021
17:39:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Jan-26-2021
17:39:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834594
Page 147 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-26-2021
17:39:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-26-2021
17:39:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-26-2021
17:40:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-26-2021
17:39:19
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834595
Page 148 of 166
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-26-2021
17:39:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Jan/26/2021Initial Entry
5.a
Date Location User Value Reason
Jan-26-2021
17:40:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BN9V3
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-26-2021
17:40:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN9V3RInitial Entry
5.b
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834596
Page 149 of 166
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Jan-26-2021
17:40:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BS682
ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-26-2021
17:40:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS682ZInitial Entry
5.c
Date Location User Value Reason
Jan-26-2021
17:41:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BS683
0Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834597
Page 150 of 166
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Sample ID
Date Location User Value Reason
Jan-26-2021
17:41:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS6830Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834598
Page 151 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-26-2021
17:41:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-26-2021
17:41:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-26-2021
17:42:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-26-2021
17:41:42
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834599
Page 152 of 166
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-26-2021
17:41:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Jan/26/2021Initial Entry
5.a
Date Location User Value Reason
Jan-26-2021
17:42:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BN9V3
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-26-2021
17:42:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN9V3NInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834600
Page 153 of 166
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-26-2021
17:43:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-26-2021
17:43:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-26-2021
17:43:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834601
Page 154 of 166
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-26-2021
17:43:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/26/2021 14:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-26-2021
17:43:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-26-2021
17:43:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-26-2021
17:43:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834602
Page 155 of 166
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
8. Actual Dose:
Date Location User Value Reason
Jan-26-2021
17:43:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-26-2021
17:43:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-26-2021
17:43:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Jan-26-2021
17:43:19ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834603
Page 156 of 166
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834604
Page 157 of 166
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-16-2021
15:04:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/16/2021Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834605
Page 158 of 166
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-16-2021
15:05:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-16-2021
15:05:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-16-2021
15:06:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-16-2021
15:05:05
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834606
Page 159 of 166
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-16-2021
15:05:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Feb/16/2021Initial Entry
5.a
Date Location User Value Reason
Feb-16-2021
15:06:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample
ID:BRCM
8MInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-16-2021
15:06:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRCM8MInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834607
Page 160 of 166
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-16-2021
15:17:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-16-2021
15:17:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-16-2021
15:17:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834608
Page 161 of 166
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-16-2021
15:17:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/16/2021 14:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-16-2021
15:17:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-16-2021
15:17:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-16-2021
15:17:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834609
Page 162 of 166
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
8. Actual Dose:
Date Location User Value Reason
Feb-16-2021
15:17:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-16-2021
15:17:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-16-2021
15:17:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-16-2021
15:17:19ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834610
Page 163 of 166
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834611
Page 164 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-20-2020
17:41:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-26-2020
18:05:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-26-2020
17:46:46
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-20-2020
17:41:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
Aug-26-2020
18:05:35ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834612
Page 165 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
Aug-26-2020
17:46:46
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834613
Page 166 of 166
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020
22:48:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e7b\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834614