125742 S1 M5 CRF c4591001 1177 11771204

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
157
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945297
Page 2 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/31/2020
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945298
Page 3 of 157
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11771204]
2.Birth Date: /1951
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): ASIAN
6.Racial Designation: JAPANESE
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945299
Page 4 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945300
Page 5 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945301
Page 6 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945302
Page 7 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dyslipidemia]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benign Prostatic Hyperplasia]
Start Date: UNK/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Obstructive Pulmonary Disease]
Start Date: UNK/UNK/2015
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Intolerance to Benazepril]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945303
Page 8 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Intolerance to Lisinopril]
Start Date: UNK/UNK/2017
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Adhesive Capsulitis, Right Shoulder]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Inguinal Hernia]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Adhesive Capsulitis, Right Shoulder]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b  
(b) (4)
FDA-CBER-2021-5683-0945304
Page 9 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Inguinal Hernia Repair]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Joint Manipulation, Right Shoulder]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945305
Page 10 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [66.0]
3.Unit: kg
4.Height: [169.0]
5.Unit: cm
6.Body Mass Index: [23.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945306
Page 11 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [247464]
3.Randomization Group: [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945307
Page 12 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BP0V1T]
5.bSample ID [BLCG6F]
5.cSample ID [BLCG6G]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945308
Page 13 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BM8GH8]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945309
Page 14 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/31/2020 09:45
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945310
Page 15 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945311
Page 16 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945312
Page 17 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945313
Page 18 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/21/2020
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 [BP8JHY]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945314
Page 19 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/21/2020 09:14
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945315
Page 20 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945316
Page 21 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS8BRH]
5.bSample ID [BS8BRJ]
5.cSample ID [BRJ56M]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945317
Page 22 of 157
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945318
Page 23 of 157
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945319
Page 24 of 157
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945320
Page 25 of 157
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945321
Page 26 of 157
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945322
Page 27 of 157
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945323
Page 28 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945324
Page 29 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945325
Page 30 of 157
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945326
Page 31 of 157
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945327
Page 32 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945328
Page 33 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945329
Page 34 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945330
Page 35 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945331
Page 36 of 157
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Identifie
rAdverse Even
tStart DateIs the Adverse Event Still Ongoi
ngForm Instance
 1.ADVERSE EVEN
T 1  Bladder Cance
r Oct/24/2020 13:0
0 YES  Repeating Pages
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945332
Page 37 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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)[Bladder Cancer]
4.Start Date Time: Oct/24/2020 13:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Neoplasia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945333
Page 38 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021036341]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945334
Page 39 of 157
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945335
Page 40 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945336
Page 41 of 157
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945337
Page 42 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: //
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945338
Page 43 of 157
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Define
d IdentifierCategory for MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1.1  CONCOMITANT IMMUNOSUPP
RESSIVE THERAPY NO  Gemzar  Unknown  Repeating
Pages
 2.2  CONCOMITANT IMMUNOSUPP
RESSIVE THERAPY NO  Cisplatin  Unknown  Repeating
Pages
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945339
Page 44 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Gemzar]
5.Dose: Unknown
[ ]Comments
6.Dose Unit: Unknown Comments
7.Dose Frequency: UNKNOWN
8.Route: INTRAVENOUS
9.Start Date: Dec/15/2020
10.Ongoing? YES
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945340
Page 45 of 157
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Cisplatin]
5.Dose: Unknown
[ ]Comments
6.Dose Unit: Unknown Comments
7.Dose Frequency: UNKNOWN
8.Route: INTRAVENOUS
9.Start Date: Dec/22/2020
10.Ongoing? YES
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945341
Page 46 of 157
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945342
Page 47 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945343
Page 48 of 157
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945344
Page 49 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945345
Page 50 of 157
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945346
Page 51 of 157
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945347
Page 52 of 157
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945348
Page 53 of 157
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945349
Page 54 of 157
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945350
Page 55 of 157
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945351
Page 56 of 157
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945352
Page 57 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945353
Page 58 of 157
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945354
Page 59 of 157
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945355
Page 60 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945356
Page 61 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/4/2021
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945357
Page 62 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945358
Page 63 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/4/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945359
Page 64 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/4/2021
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 [BS6TW0]
5.bSample ID [BS6TW1]
5.cSample ID [BR8VMM]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945360
Page 65 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/4/2021
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 [BR92HK]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945361
Page 66 of 157
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/4/2021 10:21
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945362
Page 67 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945363
Page 68 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BR92NH]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945364
Page 69 of 157
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/25/2021 10:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945365
Page 70 of 157
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945366
Page 71 of 157
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945367
Page 72 of 157
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945368
Page 73 of 157
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945369
Page 74 of 157
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945370
Page 75 of 157
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945371
Page 76 of 157
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945372
Page 77 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/19/2020
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945373
Page 78 of 157
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945374
Page 79 of 157
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
David
Fitz-Patrick Approved Mar-07-2021 14:07:27 (UTC-10:00) Aleutian
IslandsBOOK Signed
Affidavit:
By my dated signature below, I, DavidFitz-Patrick, 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.
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945375
Page 80 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormAug-31-2020 12:11:01 (UTC-10:00) Aleutian
IslandsNot Applicable
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945376
Page 81 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Jan-20-2021 08:23:04 (UTC-10:00) Aleutian Islands Unknown
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945377
Page 82 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Jan-20-2021 08:23:13 (UTC-10:00) Aleutian Islands Unknown
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945378
Page 83 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Jan-20-2021 08:24:06 (UTC-10:00) Aleutian Islands Unknown
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945379
Page 84 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Jan-20-2021 08:24:16 (UTC-10:00) Aleutian Islands Unknown
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945380
Page 85 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-04-2021 11:44:45 (UTC-10:00) Aleutian
IslandsNot Applicable
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945381
Page 86 of 157
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
David
Fitz-Patrick Approved Mar-07-2021 14:07:27 (UTC-10:00) Aleutian
IslandsBOOK Signed
Affidavit:
By my dated signature below, I, DavidFitz-Patrick, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-04-2021 11:44:30 (UTC-10:00) Aleutian
IslandsEdit - All
signatures
invalidated
Affidavit:
N/A
David
Fitz-Patrick Approved Jan-20-2021 10:38:53 (UTC-10:00) Aleutian
IslandsBOOK Signed
Affidavit:
By my dated signature below, I, DavidFitz-Patrick, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-14-2021 17:30:23 (UTC-10:00) Aleutian
IslandsEdit - All
signatures
invalidated
Affidavit:
N/A
David
Fitz-Patrick Approved Dec-10-2020 15:05:26 (UTC-10:00) Aleutian
IslandsBOOK Signed
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945382
Page 87 of 157
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Affidavit:
By my dated signature below, I, DavidFitz-Patrick, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-10-2020 13:36:28 (UTC-10:00) Aleutian
IslandsEdit - All
signatures
invalidated
Affidavit:
N/A
David
Fitz-Patrick Approved Oct-27-2020 11:43:33 (UTC-10:00) Aleutian
IslandsBOOK Signed
Affidavit:
By my dated signature below, I, DavidFitz-Patrick, 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.
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945383
Page 88 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-31-2020 12:10:33
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020 12:10:33
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945384
Page 89 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-31-2020 12:10:39
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/31/2020Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945385
Page 90 of 157
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020 12:10:25
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11771204Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020 12:10:21
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1951Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020 12:10:46
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020 12:10:46
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Dec-04-2020 10:53:16
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-04-2020 06:55:47
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Query 1: Answered Japanese
Dec-03-2020 11:33:11
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Query 1: Opened Subject is indicated
on Demography CRF
as Asian, please
specify further racial
designation as
Japanese (i.e. defined
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0945386
Page 91 of 157
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
as all four
grandparents born in
Japan, of Japanese
ancestry), or Other
Aug-31-2020 12:10:46
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
ASIANInitial Entry
6. Racial Designation:
Date Location User Value Reason
Dec-10-2020 13:36:28
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
JAPANESEInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945387
Page 92 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020 12:10:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945388
Page 93 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-31-2020 12:11:14
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020 12:11:14
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020 12:11:14
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945389
Page 94 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Aug-31-2020 12:15:33
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Hypertension
Start Date: UNK/UNK/20
17
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-31-2020 12:15:33
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 12:15:33
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-31-2020 12:15:33
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-31-2020 12:15:33
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-31-2020 12:15:50 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945390
Page 95 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00) Aleutian
Islands(autocalc) Line/MH Number: 2
Medical History Ter
m:Dyslipidemia
Start Date: UNK/UNK/20
17
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Aug-31-2020 12:15:50
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 12:15:50
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
DyslipidemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-31-2020 12:15:50
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-31-2020 12:15:50
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-31-2020 12:16:07
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:Benign Prostatic Hy
perplasia
Start Date: UNK/UNK/2019
Ongoing: YESInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945391
Page 96 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.c Line/MH Number:
Date Location User Value Reason
Aug-31-2020 12:16:07
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 12:16:07
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Benign Prostatic HyperplasiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-31-2020 12:16:07
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-31-2020 12:16:07
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-31-2020 12:16:33
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:Chronic Obstructive P
ulmonary Disease
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945392
Page 97 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.d Line/MH Number:
Date Location User Value Reason
Aug-31-2020 12:16:33
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 12:16:33
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Chronic Obstructive Pulmonary Dise
aseInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-31-2020 12:16:33
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-31-2020 12:16:33
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-31-2020 12:16:49
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:Intolerance to Ben
azepril
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945393
Page 98 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.e Line/MH Number:
Date Location User Value Reason
Aug-31-2020 12:16:49
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 12:16:49
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Intolerance to BenazeprilInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-31-2020 12:16:49
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-31-2020 12:16:49
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-31-2020 12:17:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:Intolerance to Lisi
nopril
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945394
Page 99 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.f Line/MH Number:
Date Location User Value Reason
Aug-31-2020 12:17:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 12:17:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Intolerance to LisinoprilInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-31-2020 12:17:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-31-2020 12:17:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-31-2020 12:17:20
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Histo
ry Term:Adhesive Capsulitis, R
ight Shoulder
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945395
Page 100 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.g Line/MH Number:
Date Location User Value Reason
Aug-31-2020 12:17:20
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 12:17:20
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Adhesive Capsulitis, Right ShoulderInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-31-2020 12:17:20
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-31-2020 12:17:20
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.h
Date Location User Value Reason
Aug-31-2020 12:17:36
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Te
rm:Inguinal Hernia
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1
990Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945396
Page 101 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.h Line/MH Number:
Date Location User Value Reason
Aug-31-2020 12:17:36
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 12:17:36
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Inguinal HerniaInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-31-2020 12:17:36
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-31-2020 12:17:36
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
1.i
Date Location User Value Reason
Sep-01-2020 08:26:36
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:9
Medical Hist
ory Term:Adhesive Capsulitis,
Right Shoulder
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015Transcription Error
Aug-31-2020 12:18:00
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH 9Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945397
Page 102 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Number:
Medical
History T
erm:Adhesive Capsulitis Joi
nt Manipulation, Right
Shoulder
Start Dat
e:UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945398
Page 103 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.i Line/MH Number:
Date Location User Value Reason
Aug-31-2020 12:18:00
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020
12:56:00
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Sep-01-2020
08:26:36
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Answer
edTranscription Error
Sep-01-2020
08:26:36
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Adhesive Capsul
itis, Right Shoul
derTranscription Error
Sep-01-2020
02:51:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opened Multiple concepts in
the term
ADHESIVE
CAPSULITIS
JOINT
MANIPULATION,
RIGHT
SHOULDER. Split
the term into
ADHESIVE
CAPSULITIS
RIGHT
SHOULDER and
JOINT
MANIPULATION,
RIGHT
SHOULDER and
report as 2 separate
entries. Thank you.
Aug-31-2020
12:18:00
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Adhesive Capsul
itis Joint Manipu
lation, Right Sho
ulderInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945399
Page 104 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.i Start Date:
Date Location User Value Reason
Aug-31-2020 12:18:00
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-31-2020 12:18:00
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945400
Page 105 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.j
Date Location User Value Reason
Aug-31-2020 12:18:19
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:10
Medical History
Term:Inguinal Hernia R
epair
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/19
90Initial Entry
1.j Line/MH Number:
Date Location User Value Reason
Aug-31-2020 12:18:19
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 12:18:19
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Inguinal Hernia RepairInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-31-2020 12:18:19
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-31-2020 12:18:19
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945401
Page 106 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.k
Date Location User Value Reason
Sep-01-2020 08:27:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:11
Medical Histo
ry Term:Joint Manipulation, R
ight Shoulder
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Sep-01-2020 08:27:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 08:27:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Joint Manipulation, Right ShoulderInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-01-2020 08:27:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-01-2020 08:27:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945402
Page 107 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 16:02:29
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020 16:02:29
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
66.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020 16:02:29
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-31-2020 16:02:29
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
169.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-31-2020 16:02:29
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-31-2020 16:02:29
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.1Initial Entry
7.a
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945403
Page 108 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Aug-31-2020 16:02:29
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.2
Temperature Unit: F
Temperature Locatio
n::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 16:02:29
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-31-2020 16:02:29
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-31-2020 16:02:29
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-31-2020 16:02:29
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945404
Page 109 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-31-2020 12:18:52
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User ValueReason
Sep-01-2020
09:43:01
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_DS001_07
Sep-01-2020
08:24:21
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000  Query
1: Ans
wereddata has been updated
Aug-31-2020
22:44:55
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4429329;Randomization
Number appears to be a
duplicate with Subject
11771210. Please confirm the
number has been entered
correctly or clarify.
Aug-31-2020
12:18:52
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000  Data
Entry
:
24746
4Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945405
Page 110 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 16:03:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 16:03:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 16:03:58
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 16:03:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-31-2020 16:03:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 16:03:58
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BP0V1TInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945406
Page 111 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Aug-31-2020 16:03:58
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
BP0V1TInitial Entry
5.b
Date Location User Value Reason
Sep-02-2020 09:58:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BLCG6FTranscription Error
Aug-31-2020 16:04:38
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BLCG69Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-02-2020 09:58:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
BLCG6FTranscription Error
Aug-31-2020 16:04:38
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
BLCG69Initial Entry
5.c
Date Location User Value Reason
Sep-02-2020 09:58:27
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BLCG6GTranscription Error
Aug-31-2020 16:04:48
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BLCG6BInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-02-2020 09:58:27
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
BLCG6GTranscription Error
Aug-31-2020 16:04:48
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
BLCG6BInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945407
Page 112 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 16:06:22
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 16:06:22
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 16:06:41
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 16:06:22
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-31-2020 16:06:22
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 16:06:41
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BM8GH8Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945408
Page 113 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Aug-31-2020 16:06:41
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
BM8GH8Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945409
Page 114 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020 16:07:13
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 16:07:13
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 16:07:13
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020 16:07:13
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Aug/31/2020 09:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 16:07:13
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020 16:07:13
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945410
Page 115 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Aug-31-2020 16:07:13
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020 16:07:13
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-31-2020 16:07:13
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945411
Page 116 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-31-2020 12:13:45
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945412
Page 117 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-21-2020 10:49:47
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945413
Page 118 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Sep-21-2020 11:11:50
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
2.a
Date Location User Value Reason
Sep-21-2020 11:11:50
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.0
Temperature Unit: F
Temperature Locatio
n::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-21-2020 11:11:50
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-21-2020 11:11:50
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-21-2020 11:11:50
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-21-2020 11:11:50
(UTC-10:00) AleutianACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945414
Page 119 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Islands
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945415
Page 120 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 10:49:30
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 10:49:30
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-21-2020 10:49:40
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-21-2020 10:49:30
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-21-2020 10:49:30
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
5.a
Date Location User Value Reason
Sep-21-2020 10:49:40
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BP8JHYInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945416
Page 121 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-21-2020 10:49:40
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
BP8JHYInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945417
Page 122 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-21-2020 11:06:12
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-21-2020 11:06:12
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-21-2020 11:06:12
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-21-2020 11:06:12
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sep/21/2020 09:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-21-2020 11:06:12
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-21-2020 11:06:12
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945418
Page 123 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-21-2020 11:06:12
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-21-2020 11:06:12
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-21-2020 11:06:12
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945419
Page 124 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 10:49:33
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945420
Page 125 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 10:49:41
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 10:49:41
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 10:49:55
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 10:49:41
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-19-2020 10:49:41
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020 10:49:55
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BS8BRHInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945421
Page 126 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-19-2020 10:49:55
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
BS8BRHInitial Entry
5.b
Date Location User Value Reason
Oct-19-2020 10:50:13
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BS8BRJInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020 10:50:13
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
BS8BRJInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020 10:50:26
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BRJ56MInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020 10:50:26
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
BRJ56MInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945422
Page 127 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-19-2020 10:50:36
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 10:50:36
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020 10:50:36
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945423
Page 128 of 157
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Form Created
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945424
Page 129 of 157
***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, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Bladder CancerInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Oct/24/2020 13:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945425
Page 130 of 157
***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, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
Jan-18-2021 01:12:12
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Query 1: Deleted Query can be
addressed internally
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Bladder
Cancer: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with c
ongenital anomaly or birth defect?
NO
Did this serious event result in death
?
NO
Did this serious event require or prol
ong hospitalization?
NO
Did this serious event result in persis
tent or significant disability/incapacit
y?
NO
Is this serious event life threatening?
NO
Other medically important serious ev
ent
YESInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945426
Page 131 of 157
***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, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-21-2021
04:36:49
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Close
dClose per site
response
Jan-20-2021
08:18:29
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Answ
eredData is entered
appropriately
Jan-20-2021
02:32:09
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Open
edPlease review "If
not related to
study treatment
other" field, the
following text
was indicated in
the comment
field [Neoplasia].
Any symptoms,
AEs or other key
data should be
collected on the
appropriate page.
Please review
and update as
necessary.
Jan-15-2021
15:28:10
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOT RELATE
D
If Not Relate
d to study tre
atment(s), thi
s event is due
to:
OTHERInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945427
Page 132 of 157
***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, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
If Other, s
pecify:
Neoplasi
a
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-26-2021 04:53:35
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Query 1: Closed Response satisfies query
Jan-25-2021 15:19:14
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Query 1: Answered A follow up will be submitted
Jan-24-2021 23:43:57
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2021036341 ,action
taken was reported as NOT
APPLICABLE in AE CRF while
missing in Safety database.Please
confirm. If safety update is
required, please submit a follow
up form
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-20-2021 08:32:16
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-20-2021 08:24:35
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Query 1: Answered Data was updated
Jan-20-2021 05:26:00
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Query 1: Opened Per AE log, subject is
taking meds for
chemotherapy. Please
confirm and add
Gemzar and Cisplatin
to the Con Meds
Prohibited eCRF.
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945428
Page 133 of 157
***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, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-15-2021 15:28:10
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-19-2021 01:17:41
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
2021036341Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945429
Page 134 of 157
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Jan-20-2021 08:22:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Form Created
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945430
Page 135 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Jan-20-2021 08:23:58
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Form Created
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945431
Page 136 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Jan-20-2021 08:22:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Jan-20-2021 08:22:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
CONCOMITANT IMMUNOSUPPR
ESSIVE THERAPYInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Jan-20-2021 08:22:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter the full
trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Jan-20-2021 08:22:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
GemzarInitial Entry
5. Dose:
Date Location User Value Reason
Jan-20-2021 08:23:04
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
6. Dose Unit:
Date Location User Value Reason
Jan-20-2021 08:23:13
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945432
Page 137 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7. Dose Frequency:
Date Location User Value Reason
Jan-20-2021 08:22:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UNKNOWNInitial Entry
8. Route:
Date Location User Value Reason
Jan-20-2021 08:22:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
INTRAVENOUSInitial Entry
9. Start Date:
Date Location User Value Reason
Jan-20-2021 08:22:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Dec/15/2020Initial Entry
10. Ongoing?
Date Location User Value Reason
Jan-20-2021 08:22:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945433
Page 138 of 157
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Jan-20-2021 08:23:58
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
2. Category:
Date Location User Value Reason
Jan-20-2021 08:23:58
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
CONCOMITANT IMMUNOSUPPR
ESSIVE THERAPYInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Jan-20-2021 08:23:58
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter the full
trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Jan-20-2021 08:23:58
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
CisplatinInitial Entry
5. Dose:
Date Location User Value Reason
Jan-20-2021 08:24:06
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
6. Dose Unit:
Date Location User Value Reason
Jan-20-2021 08:24:16
(UTC-10:00) AleutianACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945434
Page 139 of 157
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Islands
7. Dose Frequency:
Date Location User Value Reason
Jan-20-2021 08:23:58
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
UNKNOWNInitial Entry
8. Route:
Date Location User Value Reason
Jan-20-2021 08:23:58
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
INTRAVENOUSInitial Entry
9. Start Date:
Date Location User Value Reason
Jan-20-2021 08:23:58
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Dec/22/2020Initial Entry
10. Ongoing?
Date Location User Value Reason
Jan-20-2021 08:23:58
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945435
Page 140 of 157
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-14-2021 17:30:30
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945436
Page 141 of 157
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-14-2021 17:30:43
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Participant is willing to return for Va
ccination 3
Participant is:
eligible per local/national recomm
endations and confirmed to have r
eceived only placebo at Vaccinati
on 1/2Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945437
Page 142 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-14-2021 17:30:23
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-14-2021 17:30:23
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADDI
TIONAL VACCINATIONInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945438
Page 143 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021 11:44:30
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945439
Page 144 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-04-2021 11:44:36
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/4/2021Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945440
Page 145 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-04-2021 11:45:08
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-04-2021 11:45:08
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-04-2021 11:45:08
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945441
Page 146 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-04-2021 11:47:26
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-04-2021 11:47:26
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-04-2021 11:48:11
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-04-2021 11:47:26
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-04-2021 11:47:26
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/4/2021Initial Entry
5.a
Date Location User Value Reason
Feb-04-2021 11:48:11
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BS6TW0Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-04-2021 11:48:11 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0945442
Page 147 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00) Aleutian
IslandsBS6TW0
5.b
Date Location User Value Reason
Feb-04-2021 11:48:21
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BS6TW1Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-04-2021 11:48:21
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
BS6TW1Initial Entry
5.c
Date Location User Value Reason
Feb-04-2021 12:26:31
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BR8VMMInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-04-2021 12:26:31
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
BR8VMMInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0945443
Page 148 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-04-2021 11:48:32
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-04-2021 11:48:32
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-04-2021 12:26:47
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-04-2021 11:48:32
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-04-2021 11:48:32
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/4/2021Initial Entry
5.a
Date Location User Value Reason
Feb-04-2021 12:26:47
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BR92HKInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-04-2021 12:26:47 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0945444
Page 149 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00) Aleutian
IslandsBR92HK
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0945445
Page 150 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-04-2021 11:45:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-04-2021 11:45:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-04-2021 11:45:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-04-2021 11:45:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Feb/4/2021 10:21Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-04-2021 11:45:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-04-2021 11:45:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945446
Page 151 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Feb-04-2021 11:45:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-04-2021 11:45:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-04-2021 11:45:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-04-2021 11:45:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  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-04-2021 11:45:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945447
Page 152 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021 11:44:48
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Feb/25/2021Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945448
Page 153 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-25-2021 11:45:00
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-25-2021 11:45:00
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-25-2021 11:45:00
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Feb-25-2021 11:12:51
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Sample ID: BR92NHInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-25-2021 11:12:51
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
BR92NHInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945449
Page 154 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-25-2021 11:45:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-25-2021 11:45:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-25-2021 11:45:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-25-2021 11:45:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Feb/25/2021 10:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-25-2021 11:45:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-25-2021 11:45:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945450
Page 155 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Feb-25-2021 11:45:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-25-2021 11:45:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-25-2021 11:45:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-25-2021 11:45:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  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-25-2021 11:45:53
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945451
Page 156 of 157
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-19-2020 10:50:36
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-31-2020 12:18:52
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-31-2020 12:11:14
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-19-2020 10:50:36
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/19/2020Initial Entry
Aug-31-2020 12:18:52
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
Aug-31-2020 12:11:14
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945452
Page 157 of 157
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-26-2020 16:00:05
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2fdb\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945453
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