125742 S1 M5 CRF c4591001 1254 12541109

Document text

Page 1 of 183
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834938
Page 2 of 183
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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
Sep/8/2020
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834939
Page 3 of 183
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12541109]
2.Birth Date: 1976
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834940
Page 4 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834941
Page 5 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834942
Page 6 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/8/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834943
Page 7 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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:[heartburn]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[urinary tract infections intermittent]
Start Date: Oct/UNK/2019
Ongoing: NO
End Date:
Oct/UNK/2019
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[depression]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834944
Page 8 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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:[anxiety]
Start Date: UNK/UNK/2018
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[myopia]
Start Date: UNK/UNK/1990
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[left breast tumor]
Start Date: Sep/UNK/2019
Ongoing: NO
End Date:
Sep/UNK/2019
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834945
Page 9 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[left breast biopsy]
Start Date: Sep/UNK/2019
Ongoing: NO
End Date:
Sep/UNK/2020
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[penicillin allergy]
Start Date: UNK/UNK/1976
Ongoing: YES
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834946
Page 10 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
2.Weight: [70.31]
3.Unit: kg
4.Height: [165.1]
5.Unit: cm
6.Body Mass Index: [25.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: EAR
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834947
Page 11 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/8/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834948
Page 12 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/8/2020
2.Randomization Number: [84056]
3.Randomization Group: [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834949
Page 13 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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:
Sep/8/2020
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 [BP8JZC]
5.bSample ID [BLG844]
5.cSample ID [BLG843]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834950
Page 14 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
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 [BP8JZB]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834951
Page 15 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/8/2020 15:24
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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834952
Page 16 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834953
Page 17 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834954
Page 18 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.2]
Unit: C
Temperature Location: EAR
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834955
Page 19 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/29/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834956
Page 20 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
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 [BP8K7Y]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834957
Page 21 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/29/2020 14:42
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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834958
Page 22 of 183
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834959
Page 23 of 183
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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/27/2020
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 [BLG8KN]
5.bSample ID [BLG8KP]
5.cSample ID [BR9XX2]
5.dSample ID [BR9XX3]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834960
Page 24 of 183
***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: 12541109 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:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834961
Page 25 of 183
***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: 12541109 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: [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834962
Page 26 of 183
***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: 12541109 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 [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834963
Page 27 of 183
***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: 12541109 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 [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834964
Page 28 of 183
***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: 12541109 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?
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834965
Page 29 of 183
***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: 12541109 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:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834966
Page 30 of 183
***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: 12541109 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:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834967
Page 31 of 183
***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: 12541109 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 [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834968
Page 32 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834969
Page 33 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834970
Page 34 of 183
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/27/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834971
Page 35 of 183
***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: 12541109 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: [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834972
Page 36 of 183
***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: 12541109 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:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834973
Page 37 of 183
***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: 12541109 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 [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834974
Page 38 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Soreness at in
jection site Jan/31/2021
UNK:UNK NO
End Date Time:
Feb/1/2021 UNK:
UNK
 Repeating
Pages
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834975
Page 39 of 183
***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: 12541109 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 injection site]
4.Start Date Time: Jan/31/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/1/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834976
Page 40 of 183
***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: 12541109 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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834977
Page 41 of 183
***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: 12541109 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[ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834978
Page 42 of 183
***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: 12541109 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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834979
Page 43 of 183
***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: 12541109 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[ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834980
Page 44 of 183
***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: 12541109 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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834981
Page 45 of 183
***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: 12541109 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: //
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834982
Page 46 of 183
***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: 12541109 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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834983
Page 47 of 183
***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: 12541109 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?
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834984
Page 48 of 183
***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: 12541109 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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834985
Page 49 of 183
***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: 12541109 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?
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834986
Page 50 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834987
Page 51 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834988
Page 52 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834989
Page 53 of 183
***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: 12541109 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:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834990
Page 54 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834991
Page 55 of 183
***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: 12541109 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?
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834992
Page 56 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834993
Page 57 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834994
Page 58 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834995
Page 59 of 183
***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: 12541109 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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834996
Page 60 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/29/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834997
Page 61 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834998
Page 62 of 183
***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: 12541109 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: [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834999
Page 63 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/30/2021
2.Erroneous Visit
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835000
Page 64 of 183
***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: 12541109 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/30/2021
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835001
Page 65 of 183
***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: 12541109 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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835002
Page 66 of 183
***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: 12541109 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/30/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835003
Page 67 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/30/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835004
Page 68 of 183
***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: 12541109 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/30/2021
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 [BPFV51]
5.bSample ID [BPFV52]
5.cSample ID [BN9V5R]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835005
Page 69 of 183
***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: 12541109 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/30/2021
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 [BN9V5P]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835006
Page 70 of 183
***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: 12541109 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/30/2021 12:42
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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835007
Page 71 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/20/2021
2.Erroneous Visit
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835008
Page 72 of 183
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/20/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835009
Page 73 of 183
***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: 12541109 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/20/2021
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 [BRCM9R]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835010
Page 74 of 183
***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: 12541109 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/20/2021 12:20
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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835011
Page 75 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835012
Page 76 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835013
Page 77 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835014
Page 78 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835015
Page 79 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835016
Page 80 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835017
Page 81 of 183
***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: 12541109 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: [ ]
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835018
Page 82 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/27/2020
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835019
Page 83 of 183
***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: 12541109 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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835020
Page 84 of 183
***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: 12541109 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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835021
Page 85 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-09-2020 13:37:34 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835022
Page 86 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-30-2021 15:28:49 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835023
Page 87 of 183
***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: 12541109 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-30-2021 15:21:48 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Heller Approved Nov-03-2020 17:43:50 (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.
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835024
Page 88 of 183
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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
Sep-09-2020
13:36:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-09-2020
13:36:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835025
Page 89 of 183
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-09-2020
13:36:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Sep/8/2020Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835026
Page 90 of 183
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-09-2020
13:36:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12541109Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-09-2020
13:36:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1976Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-09-2020
13:37:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835027
Page 91 of 183
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-09-2020
13:37:11
(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
Sep-09-2020
13:37:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835028
Page 92 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-09-2020
13:37:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835029
Page 93 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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
Sep-09-2020
13:37:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-09-2020
13:37:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-09-2020
13:37:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835030
Page 94 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Sep-09-2020
13:38:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:heartbur
n
Start Date: UNK/U
NK/201
7
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-09-2020
13:38:42
(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
Sep-09-2020
13:38:42
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  Data Entry:
heartburnInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835031
Page 95 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada)
1.a Start Date:
Date Location User Value Reason
Sep-09-2020
13:38:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-09-2020
13:38:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-09-2020
13:39:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:2
Medical
History
Term:urinary tract i
nfections inte
rmittent
Start D
ate:Oct/UNK/20
19Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835032
Page 96 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Ongoin
g:NO
End Date:
Oct/UNK/
2019
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835033
Page 97 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Sep-09-2020
13:39:53
(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
Sep-09-2020
13:39:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
urinary tract infectio
ns intermittentInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-09-2020
13:39:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-09-2020
13:39:53ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835034
Page 98 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
Oct/UNK/2019
1.c
Date Location User Value Reason
Sep-09-2020
13:40:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:depressi
on
Start Date: UNK/U
NK/201
8
Ongoing: YESInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835035
Page 99 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c Line/MH Number:
Date Location User Value Reason
Sep-09-2020
13:40:25
(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
Sep-09-2020
13:40:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
depressionInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-09-2020
13:40:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-09-2020
13:40:25ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835036
Page 100 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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
Sep-09-2020
13:40:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:anxiety
Start Date: UNK/U
NK/201
8
Ongoing: YESInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835037
Page 101 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d Line/MH Number:
Date Location User Value Reason
Sep-09-2020
13:40:53
(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
Sep-09-2020
13:40:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
anxietyInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-09-2020
13:40:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-09-2020
13:40:53ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835038
Page 102 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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
Sep-09-2020
13:41:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:myopia
Start Date: UNK/U
NK/199
0
Ongoing: YESInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835039
Page 103 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Line/MH Number:
Date Location User Value Reason
Sep-09-2020
13:41:21
(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
Sep-09-2020
13:41:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
myopiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-09-2020
13:41:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-09-2020
13:41:21ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835040
Page 104 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
1.f
Date Location User Value Reason
Sep-09-2020
13:42:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical H
istory Ter
m:left breast
tumor
Start Date
:Sep/UNK/
2019
Ongoing: NO
End Dat
e:
Sep/U
NK/20
19Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835041
Page 105 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.f Line/MH Number:
Date Location User Value Reason
Sep-09-2020
13:42:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020
13:42:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
left breast tumorInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-09-2020
13:42:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/UNK/2019Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-09-2020
13:42:15ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835042
Page 106 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
Sep/UNK/2019
1.g
Date Location User Value Reason
Sep-09-2020
13:43:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical H
istory Ter
m:left breast
biopsy
Start Date
:Sep/UNK/
2019
Ongoing: NO
End Dat
e:
Sep/U
NK/20
20Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835043
Page 107 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.g Line/MH Number:
Date Location User Value Reason
Sep-09-2020
13:43:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020
13:43:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
left breast biopsyInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-09-2020
13:43:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-09-2020
13:43:16ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835044
Page 108 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
Sep/UNK/2020
1.h
Date Location User Value Reason
Sep-09-2020
15:19:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:8
Medical
History T
erm:penicill
in aller
gy
Start Dat
e:UNK/
UNK/1
976
Ongoing: YESNew
Information
Sep-09-2020
13:44:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical
History T
erm:penicill
in aller
gy
Start Dat
e:UNK/
UNK/1
976
Ongoing: NOInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835045
Page 109 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.h Line/MH Number:
Date Location User Value Reason
Sep-09-2020
13:44:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020
13:44:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
penicillin allergyInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-09-2020
13:44:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1976Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-09-2020
15:19:27ACV0PFEINFP6000  Data Entry:
YESNew
Information
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835046
Page 110 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
Sep-09-2020
13:44:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835047
Page 111 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020
13:45:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-09-2020
13:45:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
70.31Initial Entry
3. Unit:
Date Location User Value Reason
Sep-09-2020
13:45:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835048
Page 112 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-09-2020
13:45:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
165.1Initial Entry
5. Unit:
Date Location User Value Reason
Sep-09-2020
13:45:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-09-2020
13:45:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.8Initial Entry
7.a
Date Location User Value Reason
Sep-09-2020
13:45:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Identif
ier::1
Temperature: 37.
1Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835049
Page 113 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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
Sep-09-2020
13:45:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-09-2020
13:45:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
37.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-09-2020
13:45:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835050
Page 114 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.a Temperature Location:
Date Location User Value Reason
Sep-09-2020
13:45:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835051
Page 115 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-09-2020
13:45:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-09-2020
13:45:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-09-2020
13:45:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835052
Page 116 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-09-2020
13:45:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-09-2020
13:45:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-09-2020
13:45:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835053
Page 117 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-09-2020
13:45:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-09-2020
13:45:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-09-2020
13:45:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835054
Page 118 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-09-2020
13:46:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-09-2020
13:46:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
84056Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835055
Page 119 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020
15:48:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020
15:48:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020
15:48:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835056
Page 120 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-09-2020
15:48:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP8JZ
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-09-2020
15:48:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8JZCInitial Entry
5.b
Date Location User Value Reason
Sep-09-2020
16:00:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BLG84
4Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-09-2020
16:00:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLG844Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835057
Page 121 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c
Date Location User Value Reason
Sep-09-2020
16:00:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BLG84
3Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-09-2020
16:00:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLG843Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835058
Page 122 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020
15:25:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020
15:25:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020
15:25:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-09-2020
15:25:12
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835059
Page 123 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-09-2020
15:25:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-09-2020
15:25:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP8JZ
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-09-2020
15:25:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8JZBInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835060
Page 124 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-09-2020
13:46:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-09-2020
13:46:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020
13:46:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835061
Page 125 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-09-2020
13:46:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020 15:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-09-2020
13:46:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-09-2020
13:46:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-09-2020
13:46:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835062
Page 126 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-09-2020
13:46:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-09-2020
13:46:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835063
Page 127 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-09-2020
13:46:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835064
Page 128 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020
13:19:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835065
Page 129 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-30-2020
13:20:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
2.a
Date Location User Value Reason
Sep-30-2020
13:20:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Identif
ier::1
Temperature: 37.
2
Temperature
Unit:C
Temperature
Location::EA
RInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-30-2020
13:20:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835066
Page 130 of 183
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.a Temperature:
Date Location User Value Reason
Sep-30-2020
13:20:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
37.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-30-2020
13:20:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-30-2020
13:20:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835067
Page 131 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-30-2020
13:20:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-30-2020
13:20:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-30-2020
13:20:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835068
Page 132 of 183
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-30-2020
13:20:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-30-2020
13:20:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-30-2020
13:20:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835069
Page 133 of 183
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-30-2020
13:20:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-30-2020
13:20:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-30-2020
13:20:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835070
Page 134 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020
13:21:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020
13:21:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020
13:22:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-30-2020
13:21:08
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835071
Page 135 of 183
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-30-2020
13:21:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/29/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020
13:22:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP8K7
YInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-30-2020
13:22:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8K7YInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835072
Page 136 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-30-2020
13:22:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-30-2020
13:22:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-30-2020
13:22:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835073
Page 137 of 183
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-30-2020
13:22:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020 14:42Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-30-2020
13:22:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-30-2020
13:22:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-30-2020
13:22:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835074
Page 138 of 183
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-30-2020
13:22:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-30-2020
13:22:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835075
Page 139 of 183
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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-27-2020
15:59:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835076
Page 140 of 183
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020
14:47:22
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020
14:47:22
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020
14:47:46
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-28-2020
14:47:22
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835077
Page 141 of 183
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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-28-2020
14:47:22
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020
14:47:46
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BLG8K
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020
14:47:46
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLG8KNInitial Entry
5.b
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835078
Page 142 of 183
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-28-2020
14:48:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BLG8K
PInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-28-2020
14:48:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLG8KPInitial Entry
5.c
Date Location User Value Reason
Oct-28-2020
14:48:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR9XX
2Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835079
Page 143 of 183
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Sample ID
Date Location User Value Reason
Oct-28-2020
14:48:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR9XX2Initial Entry
5.d
Date Location User Value Reason
Oct-28-2020
14:48:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR9XX
3Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-28-2020
14:48:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR9XX3Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835080
Page 144 of 183
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 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-27-2020
15:59:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-27-2020
15:59:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-27-2020
15:59:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835081
Page 145 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-20-2021
13:20:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835082
Page 146 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Feb-20-2021
13:20:27
(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-20-2021
13:20:27
(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-20-2021
13:20:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Soreness at injecti
on siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835083
Page 147 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-20-2021
13:20:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/31/2021 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-20-2021
13:20:59
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-20-2021
13:20:59
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/1/2021 U
NK:UNKTranscription
Error
Feb-20-2021
13:20:27
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For Soreness
at injection site
End Date &
Time
01/Jan/2021
UNK:UNK is
before the
Start Date &
Time
31/Jan/2021
UNK:UNK.
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835084
Page 148 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-20-2021
13:20:27
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/1/2021 U
NK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-20-2021
13:20:27
(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).
Date Location User Value Reason
Feb-20-2021
13:20:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835085
Page 149 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-20-2021
13:20:27
(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-20-2021
13:20:27
(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-20-2021
13:20:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-20-2021
13:20:27ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835086
Page 150 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-20-2021
13:20:27
(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-20-2021
13:20:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-20-2021
13:20:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835087
Page 151 of 183
***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: 12541109 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-30-2021
15:22:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/29/2021Transcription
Error
Jan-30-2021
15:21:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/30/2021Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835088
Page 152 of 183
***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: 12541109 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-30-2021
15:23:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing
to return for Vaccinat
ion 3
Participant is:
eligible per local/
national recomme
ndations and conf
irmed to have rec
eived only placeb
o at Vaccination 1
/2Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835089
Page 153 of 183
***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: 12541109 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-30-2021
15:21:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/29/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-30-2021
15:21:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835090
Page 154 of 183
***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: 12541109 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-30-2021
15:25:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/30/2021Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835091
Page 155 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-30-2021
15:28:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Jan/30/2021Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835092
Page 156 of 183
***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: 12541109 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-30-2021
15:29:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/30/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-30-2021
15:29:09
(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-30-2021
15:29:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835093
Page 157 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-30-2021
15:29:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-30-2021
15:29:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-30-2021
15:29:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/30/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835094
Page 158 of 183
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-30-2021
15:29:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-30-2021
15:29:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-30-2021
15:29:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835095
Page 159 of 183
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Jan-30-2021
15:29:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-30-2021
15:29:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jan-30-2021
15:29:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835096
Page 160 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-30-2021
16:21:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-30-2021
16:21:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-30-2021
16:21:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-30-2021
16:21:12
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835097
Page 161 of 183
***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: 12541109 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-30-2021
16:21:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Jan/30/2021Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Jan-30-2021
16:22:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry: Transcription
Error
Jan-30-2021
16:22:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN9V5RKInitial Entry
5.a
Date Location User Value Reason
Jan-30-2021
16:21:28ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835098
Page 162 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)Sample ID
:BPFV5
1
5.a Sample ID
Date Location User Value Reason
Jan-30-2021
16:21:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPFV51Initial Entry
5.b
Date Location User Value Reason
Jan-30-2021
16:21:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPFV5
2Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-30-2021
16:21:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPFV52Initial Entry
5.c
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835099
Page 163 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Jan-30-2021
16:22:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BN9V5
RInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-30-2021
16:22:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN9V5RInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835100
Page 164 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-30-2021
16:23:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-30-2021
16:23:06
(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-30-2021
16:23:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-30-2021
16:23:06
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835101
Page 165 of 183
***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: 12541109 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-30-2021
16:23:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Jan/30/2021Initial Entry
5.a
Date Location User Value Reason
Jan-30-2021
16:23:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BN9V5
PInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-30-2021
16:23:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN9V5PInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835102
Page 166 of 183
***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: 12541109 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-30-2021
15:30:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-30-2021
15:30:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-30-2021
15:30:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835103
Page 167 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-30-2021
15:31:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto
Query
Jan-30-2021
15:31:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-30-2021
15:31:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/30/2021 12:42Transcription
Error
Jan-30-2021
15:30:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Dose Date,
20/Feb/2021
12:00 is a
future date
relative to when
it was entered
on 30/Jan/2021
15:30. Please
correct.
Jan-30-2021
15:30:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Dose Date is
not equal to
Date of Visit
30/Jan/2021 of
the
corresponding
Visit. Please
review and
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835104
Page 168 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
update as
appropriate.
Jan-30-2021
15:30:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/20/2021 12:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-30-2021
15:30:23
(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-30-2021
15:30:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-30-2021
15:30:23
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835105
Page 169 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada)
8. Actual Dose:
Date Location User Value Reason
Jan-30-2021
15:30:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-30-2021
15:30:23
(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-30-2021
15:30:23
(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
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835106
Page 170 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-30-2021
15:30:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835107
Page 171 of 183
***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: 12541109 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-20-2021
12:45:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/20/2021Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835108
Page 172 of 183
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-20-2021
12:45:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-20-2021
12:45:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-20-2021
12:45:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/20/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835109
Page 173 of 183
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-20-2021
12:45:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-20-2021
12:45:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-20-2021
12:45:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835110
Page 174 of 183
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Feb-20-2021
12:45:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-20-2021
12:45:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropi
n Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Feb-20-2021
12:45:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835111
Page 175 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-20-2021
12:45:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-20-2021
12:45:43
(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-20-2021
12:46:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-20-2021
12:45:43
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835112
Page 176 of 183
***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: 12541109 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-20-2021
12:45:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Feb/20/2021Initial Entry
5.a
Date Location User Value Reason
Feb-20-2021
12:46:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRCM
9RInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-20-2021
12:46:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRCM9RInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835113
Page 177 of 183
***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: 12541109 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-20-2021
13:23:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-20-2021
13:23:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-20-2021
13:23:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835114
Page 178 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-20-2021
13:23:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/20/2021 12:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-20-2021
13:23:03
(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-20-2021
13:23:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-20-2021
13:23:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835115
Page 179 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
8. Actual Dose:
Date Location User Value Reason
Feb-20-2021
13:23:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-20-2021
13:23:03
(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-20-2021
13:23:03
(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-20-2021
13:23:03ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835116
Page 180 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835117
Page 181 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-27-2020
15:59:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-09-2020
13:46:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-09-2020
13:37:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-27-2020
15:59:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/27/2020Initial Entry
Sep-09-2020
13:46:17ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/8/2020Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835118
Page 182 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)
Sep-09-2020
13:37:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/8/2020Initial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835119
Page 183 of 183
***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: 12541109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-03-2020
17:26:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e7d\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835120