125742 S1 M5 CRF c4591001 1254 12541189

Document text

Page 1 of 173
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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 version06 OCT 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835508
Page 2 of 173
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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
Oct/15/2020
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835509
Page 3 of 173
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12541189]
2.Birth Date: 1969
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):ASIAN
6.Racial Designation:
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835510
Page 4 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835511
Page 5 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835512
Page 6 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835513
Page 7 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 12541189 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:[MILD IRRITABLE BOWEL SYNDROME]
Start Date: UNK/UNK/1995
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[MILD EXERCISE INDUCED ASTHMA]
Start Date: UNK/UNK/1990
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[MALE PATTERN BALDNESS]
Start Date: Jan/UNK/2019
Ongoing: YES
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835514
Page 8 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 12541189 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:[IMPAIRED GLUCOSE TOLERANCE]
Start Date: Jun/UNK/2019
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Intermittent Eye Infection]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835515
Page 9 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835516
Page 10 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/15/2020
2.Weight: [71.2]
3.Unit: kg
4.Height: [174.0]
5.Unit: cm
6.Body Mass Index: [23.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: EAR
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835517
Page 11 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/15/2020
2.Randomization Number: [108566]
3.Randomization Group: [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835518
Page 12 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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/15/2020
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 [BLG8B2]
5.bSample ID [BLG8B3]
5.cSample ID [BR9XNM]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835519
Page 13 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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:
Oct/15/2020
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 [BR9XNJ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835520
Page 14 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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: Oct/15/2020 16:19
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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835521
Page 15 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835522
Page 16 of 173
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L 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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835523
Page 17 of 173
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Nov/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: EAR
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835524
Page 18 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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:
Nov/6/2020
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 [BR9XZ0]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835525
Page 19 of 173
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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: Nov/6/2020 10:00
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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835526
Page 20 of 173
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L 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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/4/2020
2.Erroneous Visit
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835527
Page 21 of 173
***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: 12541189 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:
Dec/4/2020
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 [BS67XP]
5.bSample ID [BS67XR]
5.cSample ID [BN9V10]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835528
Page 22 of 173
***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: 12541189 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:
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835529
Page 23 of 173
***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: 12541189 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: [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835530
Page 24 of 173
***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: 12541189 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 [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835531
Page 25 of 173
***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: 12541189 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 [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835532
Page 26 of 173
***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: 12541189 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?
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835533
Page 27 of 173
***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: 12541189 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:
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835534
Page 28 of 173
***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: 12541189 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:
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835535
Page 29 of 173
***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: 12541189 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 [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835536
Page 30 of 173
***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: 12541189 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:
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835537
Page 31 of 173
***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: 12541189 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 [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835538
Page 32 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Soreness at the I
njection Site Jan/27/202
1 18:00 NO
End Date Time:
Jan/28/2021 UNK:
UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  Headache  Jan/27/202
1 18:00 NO
End Date Time:
Jan/28/2021 UNK:
UNK
 Repeating
Pages
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835539
Page 33 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Soreness at the Injection Site]
4.Start Date Time: Jan/27/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/28/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835540
Page 34 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835541
Page 35 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835542
Page 36 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Headache]
4.Start Date Time: Jan/27/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/28/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835543
Page 37 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835544
Page 38 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835545
Page 39 of 173
***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: 12541189 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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835546
Page 40 of 173
***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: 12541189 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[ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835547
Page 41 of 173
***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: 12541189 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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835548
Page 42 of 173
***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: 12541189 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: //
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835549
Page 43 of 173
***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: 12541189 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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835550
Page 44 of 173
***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: 12541189 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?
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835551
Page 45 of 173
***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: 12541189 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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835552
Page 46 of 173
***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: 12541189 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?
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835553
Page 47 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835554
Page 48 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835555
Page 49 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835556
Page 50 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835557
Page 51 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835558
Page 52 of 173
***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: 12541189 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:
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835559
Page 53 of 173
***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: 12541189 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?
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835560
Page 54 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835561
Page 55 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835562
Page 56 of 173
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/4/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835563
Page 57 of 173
***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: 12541189 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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835564
Page 58 of 173
***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: 12541189 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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835565
Page 59 of 173
***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: 12541189 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: [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835566
Page 60 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/26/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835567
Page 61 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835568
Page 62 of 173
***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: 12541189 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: [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835569
Page 63 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835570
Page 64 of 173
***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: 12541189 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/27/2021
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835571
Page 65 of 173
***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: 12541189 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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835572
Page 66 of 173
***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: 12541189 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/27/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835573
Page 67 of 173
***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: 12541189 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/27/2021
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 [BS6839]
5.bSample ID [BS683B]
5.cSample ID [BN9V41]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835574
Page 68 of 173
***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: 12541189 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/27/2021
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 [BN9V40]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835575
Page 69 of 173
***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: 12541189 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/27/2021 11:39
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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835576
Page 70 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835577
Page 71 of 173
***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: 12541189 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/17/2021
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 [BRCM8W]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835578
Page 72 of 173
***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: 12541189 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/17/2021 11:52
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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835579
Page 73 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835580
Page 74 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835581
Page 75 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835582
Page 76 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835583
Page 77 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835584
Page 78 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835585
Page 79 of 173
***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: 12541189 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: [ ]
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835586
Page 80 of 173
***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: 12541189 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 Dec/4/2020
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835587
Page 81 of 173
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835588
Page 82 of 173
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835589
Page 83 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-16-2020 15:32:05 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835590
Page 84 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-27-2021 14:08:01 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835591
Page 85 of 173
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Jan-27-2021 14:06:32 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Heller Approved Jan-21-2021 20:18:26 (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.
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835592
Page 86 of 173
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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
Oct-16-2020
15:31:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-16-2020
15:31:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835593
Page 87 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-16-2020
15:31:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Oct/15/2020Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835594
Page 88 of 173
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-16-2020
15:31:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12541189Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-16-2020
15:31:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1969Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-16-2020
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835595
Page 89 of 173
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-16-2020
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-16-2020
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASIANInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835596
Page 90 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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-16-2020
15:31:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835597
Page 91 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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-16-2020
15:32:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020
15:32:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020
15:32:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835598
Page 92 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Oct-16-2020
15:33:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:1
Medica
l Histor
y Term:MILD IRRIT
ABLE BOW
EL SYNDR
OME
Start D
ate:UNK/UNK/1
995
Ongoin
g:YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-16-2020
15:33:25
(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
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835599
Page 93 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-16-2020
15:33:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MILD IRRITABLE
BOWEL SYNDRO
MEInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-16-2020
15:33:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-16-2020
15:33:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-16-2020
15:34:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:2Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835600
Page 94 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Medical
History
Term:MILD EXER
CISE INDU
CED ASTH
MA
Start D
ate:UNK/UNK/1
990
Ongoin
g:YES
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835601
Page 95 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Oct-16-2020
15:34:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020
15:34:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MILD EXERCISE I
NDUCED ASTHM
AInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-16-2020
15:34:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-16-2020
15:34:07ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835602
Page 96 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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
Oct-16-2020
15:34:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History
Term:MALE PAT
TERN BAL
DNESS
Start Da
te:Jan/UNK/2
019
Ongoing
:YESInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835603
Page 97 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c Line/MH Number:
Date Location User Value Reason
Oct-16-2020
15:34:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020
15:34:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALE PATTERN B
ALDNESSInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-16-2020
15:34:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-16-2020
15:34:42ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835604
Page 98 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
1.d
Date Location User Value Reason
Oct-16-2020
15:35:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:4
Medical
History
Term:IMPAIRED
GLUCOSE
TOLERANC
E
Start D
ate:Jun/UNK/20
19
Ongoin
g:YESInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835605
Page 99 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d Line/MH Number:
Date Location User Value Reason
Oct-16-2020
15:35:27
(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
Oct-16-2020
15:35:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
IMPAIRED GLUCO
SE TOLERANCEInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-16-2020
15:35:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-16-2020
15:35:27ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835606
Page 100 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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
Feb-02-2021
12:26:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical
History T
erm:Intermitten
t Eye Infec
tion
Start Dat
e:UNK/UN
K/2019
Ongoing: YESInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835607
Page 101 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Line/MH Number:
Date Location User Value Reason
Feb-02-2021
12:26:51
(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
Feb-02-2021
12:26:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Intermittent Eye Infe
ctionInitial Entry
1.e Start Date:
Date Location User Value Reason
Feb-02-2021
12:26:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Feb-02-2021
12:26:51ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835608
Page 102 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835609
Page 103 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-16-2020
15:35:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT
known to be HIV P
OSITIVEInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835610
Page 104 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-16-2020
15:36:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-16-2020
15:36:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
71.2Initial Entry
3. Unit:
Date Location User Value Reason
Oct-16-2020
15:36:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835611
Page 105 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-16-2020
15:36:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
174.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-16-2020
15:36:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-16-2020
15:36:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.5Initial Entry
7.a
Date Location User Value Reason
Oct-16-2020
15:36:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Identif
ier::1
Temperature: 36.
9Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835612
Page 106 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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
Oct-16-2020
15:36:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-16-2020
15:36:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-16-2020
15:36:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835613
Page 107 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.a Temperature Location:
Date Location User Value Reason
Oct-16-2020
15:36:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835614
Page 108 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-16-2020
15:36:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-16-2020
15:36:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
108566Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835615
Page 109 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020
15:38:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020
15:38:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020
15:38:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-16-2020
15:38:10
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835616
Page 110 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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-16-2020
15:38:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020
15:38:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BLG8B
2Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-16-2020
15:38:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLG8B2Initial Entry
5.b
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835617
Page 111 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-16-2020
15:38:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BLG8B
3Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-16-2020
15:38:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLG8B3Initial Entry
5.c
Date Location User Value Reason
Oct-16-2020
15:39:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR9XN
MInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835618
Page 112 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Sample ID
Date Location User Value Reason
Oct-16-2020
15:39:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR9XNMInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835619
Page 113 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020
15:45:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020
15:45:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020
15:46:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-16-2020
15:45:41
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835620
Page 114 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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-16-2020
15:45:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020
15:46:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR9XN
JInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-16-2020
15:46:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR9XNJInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835621
Page 115 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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
Oct-16-2020
15:46:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-16-2020
15:46:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-16-2020
15:46:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835622
Page 116 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-16-2020
15:46:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020 16:19Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-16-2020
15:46:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-16-2020
15:46:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-16-2020
15:46:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835623
Page 117 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-16-2020
15:46:44
(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
Oct-16-2020
15:46:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835624
Page 118 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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
Oct-16-2020
15:46:52
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835625
Page 119 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020
11:40:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/6/2020Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835626
Page 120 of 173
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Nov-06-2020
11:41:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/6/2020Initial Entry
2.a
Date Location User Value Reason
Nov-06-2020
11:41:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Identif
ier::1
Temperature: 36.
6
Temperature
Unit:C
Temperature
Location::EA
RInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-06-2020
11:41:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835627
Page 121 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.a Temperature:
Date Location User Value Reason
Nov-06-2020
11:41:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-06-2020
11:41:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-06-2020
11:41:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835628
Page 122 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020
13:25:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020
13:25:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020
13:26:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-06-2020
13:25:30
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835629
Page 123 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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.
Nov-06-2020
13:25:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Nov/6/2020Initial Entry
5.a
Date Location User Value Reason
Nov-06-2020
13:26:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR9XZ
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-06-2020
13:26:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR9XZ0Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835630
Page 124 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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
Nov-06-2020
11:41:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-06-2020
11:41:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-06-2020
11:41:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835631
Page 125 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-06-2020
11:41:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/6/2020 10:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-06-2020
11:41:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-06-2020
11:41:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-06-2020
11:41:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835632
Page 126 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-06-2020
11:41:58
(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
Nov-06-2020
11:41:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835633
Page 127 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-08-2020
20:55:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Dec-08-2020
10:22:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dEOT has been
completed
Dec-07-2020
02:48:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
treatment
period is
defined as 1st
vaccination
visit through
the 1-month
post
vaccination
visit after the
2nd
vaccination.
Please
complete
treatment
disposition
CRF and
update date of
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835634
Page 128 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
EOT to match
date of visit at
visit 3.
Dec-04-2020
10:02:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/4/2020Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835635
Page 129 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-04-2020
10:02:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-04-2020
10:02:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-04-2020
12:40:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-04-2020
10:02:41
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835636
Page 130 of 173
***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: 12541189 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.
Dec-04-2020
10:02:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Dec/4/2020Initial Entry
5.a
Date Location User Value Reason
Dec-04-2020
12:40:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BS67X
PInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-04-2020
12:40:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS67XPInitial Entry
5.b
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835637
Page 131 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Dec-04-2020
12:41:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BS67X
RInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-04-2020
12:41:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS67XRInitial Entry
5.c
Date Location User Value Reason
Dec-04-2020
12:42:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BN9V1
0Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835638
Page 132 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Sample ID
Date Location User Value Reason
Dec-04-2020
12:42:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN9V10Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835639
Page 133 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-10-2021
16:02:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835640
Page 134 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835641
Page 135 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Feb-10-2021
16:02:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-10-2021
16:02:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-10-2021
16:02:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Soreness at the Inject
ion SiteInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835642
Page 136 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-10-2021
16:02:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-10-2021
16:02:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/28/2021 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-10-2021
16:02:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835643
Page 137 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Feb-10-2021
16:02:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-10-2021
16:02:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-10-2021
16:02:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-10-2021
16:02:45
(UTC-08:00)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835644
Page 138 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-10-2021
16:02:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-10-2021
16:04:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-10-2021
16:02:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835645
Page 139 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Feb-10-2021
16:02:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835646
Page 140 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
4. Start Date Time:
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835647
Page 141 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/28/2021 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835648
Page 142 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835649
Page 143 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835650
Page 144 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-10-2021
16:06:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835651
Page 145 of 173
***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, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 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
Dec-08-2020
10:22:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-08-2020
10:22:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-08-2020
10:22:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835652
Page 146 of 173
***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: 12541189 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-27-2021
14:06:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/26/2021Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835653
Page 147 of 173
***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: 12541189 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-27-2021
14:07:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-27-2021
14:06:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-27-2021
14:06:48
(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 recom
mendations and
confirmed to haInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835654
Page 148 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
ve received onl
y placebo at Va
ccination 1/2
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835655
Page 149 of 173
***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: 12541189 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-27-2021
14:07:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/26/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-27-2021
14:07:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835656
Page 150 of 173
***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: 12541189 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-27-2021
14:07:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835657
Page 151 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-27-2021
14:07:52
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Jan/27/2021Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835658
Page 152 of 173
***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: 12541189 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-27-2021
14:08:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-27-2021
14:08:20
(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-27-2021
14:08:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835659
Page 153 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021
14:19:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021
14:19:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021
14:19:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-27-2021
14:19:17
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835660
Page 154 of 173
***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: 12541189 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-27-2021
14:19:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Jan/27/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021
14:19:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BS683
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-27-2021
14:19:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS6839Initial Entry
5.b
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835661
Page 155 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Jan-27-2021
14:19:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BS683
BInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-27-2021
14:19:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS683BInitial Entry
5.c
Date Location User Value Reason
Jan-27-2021
14:21:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BN9V4
1Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835662
Page 156 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Sample ID
Date Location User Value Reason
Jan-27-2021
14:21:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN9V41Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835663
Page 157 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021
14:23:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021
14:23:13
(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-27-2021
14:23:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-27-2021
14:23:13
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835664
Page 158 of 173
***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: 12541189 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-27-2021
14:23:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Jan/27/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021
14:23:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BN9V4
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-27-2021
14:23:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN9V40Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835665
Page 159 of 173
***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: 12541189 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-27-2021
14:09:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-27-2021
14:09:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-27-2021
14:09:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835666
Page 160 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-27-2021
14:09:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021 11:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-27-2021
14:09:49
(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-27-2021
14:09:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-27-2021
14:09:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835667
Page 161 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
8. Actual Dose:
Date Location User Value Reason
Jan-27-2021
14:09:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-27-2021
14:09:49
(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-27-2021
14:09:49
(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-27-2021
14:09:49ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835668
Page 162 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835669
Page 163 of 173
***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: 12541189 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-17-2021
14:49:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/17/2021Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835670
Page 164 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-17-2021
14:49:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-17-2021
14:49:32
(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-17-2021
14:50:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-17-2021
14:49:32
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835671
Page 165 of 173
***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: 12541189 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-17-2021
14:49:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Feb/17/2021Initial Entry
5.a
Date Location User Value Reason
Feb-18-2021
09:27:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRCM8
WTranscription
Error
Feb-17-2021
14:50:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRCM
8VInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-18-2021
09:27:31
(UTC-08:00)ACV0PFEINFP6000  Data Entry:
BRCM8WTranscription
Error
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835672
Page 166 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)
Feb-17-2021
14:50:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRCM8VInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835673
Page 167 of 173
***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: 12541189 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-17-2021
15:05:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-17-2021
15:05:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-17-2021
15:05:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835674
Page 168 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-17-2021
15:05:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/17/2021 11:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-17-2021
15:05:29
(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-17-2021
15:05:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-17-2021
15:05:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835675
Page 169 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
8. Actual Dose:
Date Location User Value Reason
Feb-17-2021
15:05:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-17-2021
15:05:29
(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-17-2021
15:05:29
(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-17-2021
15:05:29ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835676
Page 170 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835677
Page 171 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-08-2020
10:22:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-16-2020
15:36:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-16-2020
15:32:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-08-2020
10:22:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/4/2020Initial Entry
Oct-16-2020
15:36:42ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/15/2020Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835678
Page 172 of 173
***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: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
Oct-16-2020
15:32:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/15/2020Initial Entry
090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835679
Page 173 of 173
***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, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541189 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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Date Location User Value Reason
Jan-21-2021
20:06:22
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090177e196ae3e7f\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835680