125742 S1 M5 CRF c4591001 1177 11771222

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
201
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 201
***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: 11771222 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
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945454
Page 2 of 201
***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: 11771222 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
Sep/1/2020
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945455
Page 3 of 201
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11771222]
2.Birth Date: /1984
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945456
Page 4 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945457
Page 5 of 201
***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: 11771222 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
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945458
Page 6 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945459
Page 7 of 201
***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: 11771222 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:[ALLERGY TO CAT DANDER]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ALLERGY TO DOG DANDER]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ASTHMA]
Start Date: UNK/UNK/1993
Ongoing: YES
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945460
Page 8 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CHOLECYSTITIS]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[TONSILLITIS]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CHILDBIRTH]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945461
Page 9 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CHILDBIRTH]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CESAREAN SECTION]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CESAREAN SECTION]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945462
Page 10 of 201
***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: 11771222 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:[TONSILLECTOMY]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.kLine/MH Number: [11]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CHOLECYSTECTOMY]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
1.lLine/MH Number: [12]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BUNIONS, BOTH FEET]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
Jun/UNK/2020
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945463
Page 11 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.mLine/MH Number: [13]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BUNIONECTOMY, RIGHT FOOT]
Start Date: Dec/UNK/2019
Ongoing: NO
End Date:
Dec/UNK/2019
1.nLine/MH Number: [14]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BUNIONECTOMY, LEFT FOOT]
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
Jun/UNK/2020
1.oLine/MH Number: [15]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[SEPTOPLASTY]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945464
Page 12 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.pLine/MH Number: [16]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[DEVIATED SEPTUM]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945465
Page 13 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
2.Weight: [88.6]
3.Unit: kg
4.Height: [169.9]
5.Unit: cm
6.Body Mass Index: [30.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945466
Page 14 of 201
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/1/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945467
Page 15 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/1/2020
2.Randomization Number: [77093]
3.Randomization Group: [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945468
Page 16 of 201
***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: 11771222 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:
Sep/1/2020
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 [BP0V2D]
5.bSample ID [BLCG7M]
5.cSample ID [BLCG7N]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945469
Page 17 of 201
***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: 11771222 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/1/2020
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 [BM8GHW]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945470
Page 18 of 201
***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: 11771222 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/1/2020 08:18
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945471
Page 19 of 201
***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: 11771222 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
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945472
Page 20 of 201
***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: 11771222 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
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945473
Page 21 of 201
***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: 11771222 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: [97.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945474
Page 22 of 201
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/21/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945475
Page 23 of 201
***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: 11771222 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 [BP8JHS]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945476
Page 24 of 201
***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: 11771222 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 08:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945477
Page 25 of 201
***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: 11771222 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
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945478
Page 26 of 201
***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: 11771222 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 [BRJ56H]
5.bSample ID [BS8BR8]
5.cSample ID [BS8BR7]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945479
Page 27 of 201
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945480
Page 28 of 201
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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 [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945481
Page 29 of 201
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L 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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945482
Page 30 of 201
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: 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: 11771222 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 [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945483
Page 31 of 201
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L 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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945484
Page 32 of 201
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: 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: 11771222 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 [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945485
Page 33 of 201
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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:
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945486
Page 34 of 201
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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: [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945487
Page 35 of 201
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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 [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945488
Page 36 of 201
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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 [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945489
Page 37 of 201
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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?
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945490
Page 38 of 201
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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:
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945491
Page 39 of 201
***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: 11771222 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:
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945492
Page 40 of 201
***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: 11771222 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 [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945493
Page 41 of 201
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945494
Page 42 of 201
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945495
Page 43 of 201
***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: 11771222 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: [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945496
Page 44 of 201
***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: 11771222 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: [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945497
Page 45 of 201
***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: 11771222 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:
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945498
Page 46 of 201
***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: 11771222 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 [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945499
Page 47 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  BODY ACHES  Sep/21/202
0 18:00 NO
End Date Time:
Sep/23/2020 07:30
 Repeating
Pages
 2.ADVERSE
EVENT 2  HEADACHE  Sep/21/202
0 18:00 NO
End Date Time:
Sep/23/2020 07:30
 Repeating
Pages
 3.ADVERSE
EVENT 3  NAUSEA  Sep/21/202
0 18:00 NO
End Date Time:
Sep/21/2020 21:00
 Repeating
Pages
 4.ADVERSE
EVENT 4  Exposure Durin
g Pregnancy Nov/13/20
20 18:00 NO
End Date Time:
Dec/23/2020 12:0
0
 Repeating
Pages
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945500
Page 48 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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)[BODY ACHES]
4.Start Date Time: Sep/21/2020 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/23/2020 07:30
6.Toxicity Grade: 3
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945501
Page 49 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945502
Page 50 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945503
Page 51 of 201
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[HEADACHE]
4.Start Date Time: Sep/21/2020 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/23/2020 07:30
6.Toxicity Grade: 2
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945504
Page 52 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945505
Page 53 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945506
Page 54 of 201
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[NAUSEA]
4.Start Date Time: Sep/21/2020 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/21/2020 21:00
6.Toxicity Grade: 1
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945507
Page 55 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945508
Page 56 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945509
Page 57 of 201
***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: 11771222 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: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Exposure During Pregnancy]
4.Start Date Time: Nov/13/2020 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/23/2020 12:00
6.Toxicity Grade: Not Applicable Comments
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945510
Page 58 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is
due to:
OTHER
If Other, specify:
[Conception]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945511
Page 59 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945512
Page 60 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945513
Page 61 of 201
***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: 11771222 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[ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945514
Page 62 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945515
Page 63 of 201
***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: 11771222 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: //
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945516
Page 64 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945517
Page 65 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945518
Page 66 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945519
Page 67 of 201
***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: 11771222 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?
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945520
Page 68 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945521
Page 69 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945522
Page 70 of 201
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945523
Page 71 of 201
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11771222 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:
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945524
Page 72 of 201
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945525
Page 73 of 201
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11771222 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?
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945526
Page 74 of 201
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945527
Page 75 of 201
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945528
Page 76 of 201
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945529
Page 77 of 201
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945530
Page 78 of 201
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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 [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945531
Page 79 of 201
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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 [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945532
Page 80 of 201
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945533
Page 81 of 201
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945534
Page 82 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/17/2020
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945535
Page 83 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945536
Page 84 of 201
***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: 11771222 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: [ ]
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945537
Page 85 of 201
***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: 11771222 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
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945538
Page 86 of 201
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945539
Page 87 of 201
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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-09-2021 12:05:39 (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.
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945540
Page 88 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-01-2020 09:18:27 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945541
Page 89 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Dec-08-2020 12:07:48 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945542
Page 90 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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-09-2021 12:05:39 (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 Mar-09-2021 12:05:10 (UTC-10:00)
Aleutian IslandsEdit - All
signatures
invalidated
Affidavit:
N/A
David
Fitz-Patrick Approved Jan-20-2021 10:42:23 (UTC-10:00)
Aleutian IslandsBOOK Signed
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945543
Page 91 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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-17-2020 18:01:46 (UTC-10:00)
Aleutian IslandsEdit - All
signatures
invalidated
Affidavit:
N/A
David
Fitz-Patrick Approved Dec-09-2020 08:40:30 (UTC-10:00)
Aleutian IslandsBOOK Signed
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945544
Page 92 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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-04-2020 12:29:06 (UTC-10:00)
Aleutian IslandsEdit - All
signatures
invalidated
Affidavit:
N/A
David
Fitz-Patrick Approved Oct-27-2020 11:49:20 (UTC-10:00)
Aleutian IslandsBOOK Signed
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945545
Page 93 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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.
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945546
Page 94 of 201
***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: 11771222 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
Sep-01-2020
09:17:35
(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
Sep-01-2020
09:17:35
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945547
Page 95 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-01-2020
09:17:44
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/1/2020Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945548
Page 96 of 201
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-01-2020
09:17:15
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11771222Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-01-2020
09:17:11
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1984Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-01-2020
09:17:59
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-01-2020
09:17:59ACV0PFEINFP6000  Data Entry:
NOT HISPANIC ORInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945549
Page 97 of 201
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00)
Aleutian IslandsLATINO(A) OR OF
SPANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-01-2020
09:17:59
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945550
Page 98 of 201
***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: 11771222 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-01-2020
09:18:12
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945551
Page 99 of 201
***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: 11771222 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
Sep-01-2020
09:18:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-01-2020
09:18:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-01-2020
09:18:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945552
Page 100 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Sep-01-2020
09:27:22
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical
History
Term:ALLERGY
TO CAT D
ANDER
Start Dat
e:UNK/UNK/
2010
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:27:22
(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
Sep-01-2020
09:27:22
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
ALLERGY TO CAT
DANDERInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945553
Page 101 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.a Start Date:
Date Location User Value Reason
Sep-01-2020
09:27:22
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-01-2020
09:27:22
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-01-2020
09:27:37
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History
Term:ALLERGY
TO DOG D
ANDER
Start Da
te:UNK/UNK/
2010
Ongoing
:YESInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945554
Page 102 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.b Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:27:37
(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
Sep-01-2020
09:27:37
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
ALLERGY TO DOG
DANDERInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-01-2020
09:27:37
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-01-2020
09:27:37
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fda\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-2021-5683-0945555
Page 103 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.c
Date Location User Value Reason
Sep-01-2020
09:27:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:ASTHM
A
Start Date: UNK/U
NK/1993
Ongoing: YESInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945556
Page 104 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.c Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:27:51
(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
Sep-01-2020
09:27:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
ASTHMAInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-01-2020
09:27:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/1993Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-01-2020
09:27:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fda\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-2021-5683-0945557
Page 105 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.d
Date Location User Value Reason
Sep-01-2020
09:29:10
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:CHOLEC
YSTITIS
Start Date
:UNK/UN
K/2007
Ongoing: NO
End Date
:
UNK/U
NK/200
7Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945558
Page 106 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.d Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:29:10
(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
Sep-01-2020
09:29:10
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
CHOLECYSTITISInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-01-2020
09:29:10
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-01-2020
09:29:10
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2fda\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-2021-5683-0945559
Page 107 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
UNK/UNK/2007
1.e
Date Location User Value Reason
Sep-01-2020
09:29:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical H
istory Ter
m:TONSILLI
TIS
Start Date
:UNK/UN
K/2005
Ongoing: NO
End Date
:
UNK/U
NK/200
5Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945560
Page 108 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.e Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:29:26
(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
Sep-01-2020
09:29:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
TONSILLITISInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-01-2020
09:29:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-01-2020
09:29:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2fda\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-2021-5683-0945561
Page 109 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
UNK/UNK/2005
1.f
Date Location User Value Reason
Sep-01-2020
09:29:58
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Line/M
H Numb
er:6
Medical
History
Term:CHILDB
IRTH
Start Da
te:UNK/UN
K/2013
Ongoing
:NO
End Da
te:
UNK/
UNK/
2013Transcription
Error
Sep-01-2020
09:29:44
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:6
Medical
History
Term:CHILDB
RITH
Start Da
te:UNK/UN
K/2013Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945562
Page 110 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Ongoing
:NO
End Da
te:
UNK/
UNK/
2013
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945563
Page 111 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.f Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:29:44
(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
Sep-01-2020
09:29:58
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
CHILDBIRTHTranscription
Error
Sep-01-2020
09:29:44
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
CHILDBRITHInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-01-2020
09:29:44
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.f Ongoing:
Date Location User Value Reason
090177e196ae2fda\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-2021-5683-0945564
Page 112 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-01-2020
09:29:44
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.g
Date Location User Value Reason
Sep-01-2020
09:30:11
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical H
istory Ter
m:CHILDBI
RTH
Start Date
:UNK/UN
K/2016
Ongoing: NO
End Date
:
UNK/U
NK/201
6Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945565
Page 113 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.g Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:30:11
(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
Sep-01-2020
09:30:11
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
CHILDBIRTHInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-01-2020
09:30:11
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-01-2020
09:30:11
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2fda\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-2021-5683-0945566
Page 114 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
UNK/UNK/2016
1.h
Date Location User Value Reason
Sep-01-2020
09:30:43
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical
History T
erm:CESAREA
N SECTIO
N
Start Dat
e:UNK/UNK
/2013
Ongoing: NO
End Date:
UNK/U
NK/201
3Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945567
Page 115 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.h Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:30:43
(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
Sep-01-2020
09:30:43
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
CESAREAN SECTI
ONInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-01-2020
09:30:43
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-01-2020
09:30:43
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2fda\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-2021-5683-0945568
Page 116 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
UNK/UNK/2013
1.i
Date Location User Value Reason
Sep-01-2020
09:30:56
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:9
Medical
History T
erm:CESAREA
N SECTIO
N
Start Dat
e:UNK/UNK
/2016
Ongoing: NO
End Date:
UNK/U
NK/201
6Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945569
Page 117 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.i Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:30:56
(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
09:30:56
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
CESAREAN SECTI
ONInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-01-2020
09:30:56
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-01-2020
09:30:56
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2fda\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-2021-5683-0945570
Page 118 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
UNK/UNK/2016
1.j
Date Location User Value Reason
Sep-01-2020
09:31:15
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:10
Medical H
istory Ter
m:TONSILL
ECTOMY
Start Date
:UNK/UN
K/2005
Ongoing: NO
End Date
:
UNK/U
NK/200
5Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945571
Page 119 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.j Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:31:15
(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
Sep-01-2020
09:31:15
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
TONSILLECTOMYInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945572
Page 120 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.j Start Date:
Date Location User Value Reason
Sep-01-2020
09:31:15
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-01-2020
09:31:15
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.k
Date Location User Value Reason
Sep-01-2020
09:31:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:11
Medical
History T
erm:CHOLECY
STECTOM
Y
Start Dat
e:UNK/UNK/
2007Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945573
Page 121 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Ongoing: NO
End Date:
UNK/U
NK/200
7
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945574
Page 122 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.k Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:31:39
(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
09:31:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
CHOLECYSTECTO
MYInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-01-2020
09:31:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-01-2020
09:31:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2fda\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-2021-5683-0945575
Page 123 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
UNK/UNK/2007
1.l
Date Location User Value Reason
Sep-01-2020
09:32:09
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:12
Medical
History T
erm:BUNIONS,
BOTH FEE
T
Start Dat
e:UNK/UNK/
2018
Ongoing: NO
End Date:
Jun/UN
K/2020Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945576
Page 124 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.l Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:32:09
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020
09:32:09
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
BUNIONS, BOTH F
EETInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-01-2020
09:32:09
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-01-2020
09:32:09
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2fda\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-2021-5683-0945577
Page 125 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jun/UNK/2020
1.m
Date Location User Value Reason
Sep-01-2020
09:32:42
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:13
Medical
History
Term:BUNIONEC
TOMY, RIG
HT FOOT
Start D
ate:Dec/UNK/20
19
Ongoin
g:NO
End Date:
Dec/UNK
/2019Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945578
Page 126 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.m Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:32:42
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020
09:32:42
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
BUNIONECTOMY,
RIGHT FOOTInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-01-2020
09:32:42
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Dec/UNK/2019Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-01-2020
09:32:42
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2fda\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-2021-5683-0945579
Page 127 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Dec/UNK/2019
1.n
Date Location User Value Reason
Sep-01-2020
09:33:08
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:14
Medical
History
Term:BUNIONEC
TOMY, LEF
T FOOT
Start D
ate:Jun/UNK/20
20
Ongoin
g:NO
End Date:
Jun/UNK/
2020Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945580
Page 128 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.n Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:33:08
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020
09:33:08
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
BUNIONECTOMY,
LEFT FOOTInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-01-2020
09:33:08
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Jun/UNK/2020Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-01-2020
09:33:08
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2fda\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-2021-5683-0945581
Page 129 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jun/UNK/2020
1.o
Date Location User Value Reason
Sep-01-2020
09:40:12
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:15
Medical H
istory Ter
m:SEPTOPL
ASTY
Start Date
:UNK/UN
K/2005
Ongoing: NO
End Date
:
UNK/U
NK/200
5Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945582
Page 130 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.o Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:40:12
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020
09:40:12
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
SEPTOPLASTYInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-01-2020
09:40:12
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-01-2020
09:40:12
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2fda\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-2021-5683-0945583
Page 131 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
UNK/UNK/2005
1.p
Date Location User Value Reason
Sep-01-2020
09:40:41
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:16
Medical
History T
erm:DEVIATE
D SEPTU
M
Start Dat
e:UNK/UNK
/2005
Ongoing: NO
End Date:
UNK/U
NK/200
5Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945584
Page 132 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.p Line/MH Number:
Date Location User Value Reason
Sep-01-2020
09:40:41
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020
09:40:41
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
DEVIATED SEPTU
MInitial Entry
1.p Start Date:
Date Location User Value Reason
Sep-01-2020
09:40:41
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-01-2020
09:40:41
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2fda\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-2021-5683-0945585
Page 133 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
UNK/UNK/2005
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945586
Page 134 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020
09:43:07
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-01-2020
09:43:07
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
88.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-01-2020
09:43:07
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-01-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fda\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) (6)
FDA-CBER-2021-5683-0945587
Page 135 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
09:43:07
(UTC-10:00)
Aleutian Islands169.9
5. Unit:
Date Location User Value Reason
Sep-01-2020
09:43:07
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-01-2020
09:43:07
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.7Initial Entry
7.a
Date Location User Value Reason
Sep-01-2020
09:43:07
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:98.1
Temperatur
e Unit:FInitial Entry
090177e196ae2fda\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-2021-5683-0945588
Page 136 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Temperatur
e Location::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Sep-01-2020
09:43:07
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-01-2020
09:43:07
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-01-2020
09:43:07
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2fda\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-2021-5683-0945589
Page 137 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-01-2020
09:43:07
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945590
Page 138 of 201
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-01-2020
09:26:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-01-2020
09:26:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-01-2020
09:26:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-01-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945591
Page 139 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
09:26:26
(UTC-10:00)
Aleutian Islands(autocalc) STUDY SITE
5. Specimen Type:
Date Location User Value Reason
Sep-01-2020
09:26:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-01-2020
09:26:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945592
Page 140 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-01-2020
09:26:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-01-2020
09:26:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-01-2020
09:26:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945593
Page 141 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-01-2020
09:21:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-01-2020
09:21:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
77093Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945594
Page 142 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020
09:51:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020
09:51:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020
09:51:48
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-01-2020
09:51:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945595
Page 143 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Please review
and correct as
appropriate.
Sep-01-2020
09:51:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020
09:51:48
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sample ID
:BP0V2
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020
09:51:48
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
BP0V2DInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020
09:51:59ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fda\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-2021-5683-0945596
Page 144 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00)
Aleutian IslandsSample I
D:BLCG7
M
5.b Sample ID
Date Location User Value Reason
Sep-01-2020
09:51:59
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
BLCG7MInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020
09:52:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sample I
D:BLCG7
NInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020
09:52:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
BLCG7NInitial Entry
090177e196ae2fda\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-2021-5683-0945597
Page 145 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020
09:52:20
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020
09:52:20
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020
09:52:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-01-2020
09:52:20
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945598
Page 146 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Please review
and correct as
appropriate.
Sep-01-2020
09:52:20
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020
09:52:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sample I
D:BM8GH
WInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020
09:52:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
BM8GHWInitial Entry
090177e196ae2fda\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-2021-5683-0945599
Page 147 of 201
***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: 11771222 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-01-2020
09:53:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020
09:52:56
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020
09:52:56
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-01-2020
09:52:56ACV0PFEINFP6000  Data Entry:
Sep/1/2020 08:18Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945600
Page 148 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00)
Aleutian Islands
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020
09:52:56
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-01-2020
09:52:56
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-01-2020
09:52:56
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020
09:52:56ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945601
Page 149 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00)
Aleutian IslandsCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-01-2020
09:52:56
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945602
Page 150 of 201
***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: 11771222 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
Sep-01-2020
09:21:53
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945603
Page 151 of 201
***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: 11771222 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
09:16:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945604
Page 152 of 201
***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: 11771222 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
09:16:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
2.a
Date Location User Value Reason
Sep-21-2020
09:16:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:97.7
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-21-2020
09:16:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2fda\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-2021-5683-0945605
Page 153 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.a Temperature:
Date Location User Value Reason
Sep-21-2020
09:16:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-21-2020
09:16:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-21-2020
09:16:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2fda\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-2021-5683-0945606
Page 154 of 201
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-21-2020
09:16:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-21-2020
09:16:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-21-2020
09:16:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-21-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945607
Page 155 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
09:16:51
(UTC-10:00)
Aleutian Islands(autocalc) STUDY SITE
5. Specimen Type:
Date Location User Value Reason
Sep-21-2020
09:16:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-21-2020
09:16:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945608
Page 156 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-21-2020
09:16:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-21-2020
09:16:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-21-2020
09:16:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945609
Page 157 of 201
***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: 11771222 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
09:49:27
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020
09:49:27
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-21-2020
09:49:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-21-2020
09:49:27
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945610
Page 158 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Please review
and correct as
appropriate.
Sep-21-2020
09:49:27
(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
09:49:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sample ID
:BP8JH
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-21-2020
09:49:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
BP8JHSInitial Entry
090177e196ae2fda\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-2021-5683-0945611
Page 159 of 201
***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: 11771222 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
09:52:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-21-2020
09:52:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-21-2020
09:52:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-21-2020
09:52:14ACV0PFEINFP6000  Data Entry:
Sep/21/2020 08:22Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945612
Page 160 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00)
Aleutian Islands
5. Anatomical Location:
Date Location User Value Reason
Sep-21-2020
09:52:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-21-2020
09:52:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-21-2020
09:52:14
(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
09:52:14ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945613
Page 161 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00)
Aleutian IslandsCIFIED OBSERVATIO
N PERIOD
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
09:52:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945614
Page 162 of 201
***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: 11771222 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
08:55:32
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945615
Page 163 of 201
***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: 11771222 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
08:55:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020
08:55:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020
09:00:55
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
08:55:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945616
Page 164 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Please review
and correct as
appropriate.
Oct-19-2020
08:55:38
(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
09:00:55
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sample ID
:BRJ56
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020
09:00:55
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
BRJ56HInitial Entry
5.b
Date Location User Value Reason
Oct-19-2020
09:01:05
(UTC-10:00)ACV0PFEINFP6000  Data Entry:
Sample ID BS8BRInitial Entry
090177e196ae2fda\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-2021-5683-0945617
Page 165 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Aleutian Islands : 8
5.b Sample ID
Date Location User Value Reason
Oct-19-2020
09:01:05
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
BS8BR8Initial Entry
5.c
Date Location User Value Reason
Oct-19-2020
09:01:12
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sample ID
:BS8BR
7Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020
09:01:12
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
BS8BR7Initial Entry
090177e196ae2fda\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-2021-5683-0945618
Page 166 of 201
***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: 11771222 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
08:55:48
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020
08:55:48
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020
08:55:48
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945619
Page 167 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Sep-22-2020
16:17:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Form Created
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945620
Page 168 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Form Created
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945621
Page 169 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Form Created
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945622
Page 170 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Form Created
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0945623
Page 171 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Sep-22-2020
16:17:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-22-2020
16:17:14
(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
Sep-22-2020
16:17:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
BODY ACHESInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-22-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945624
Page 172 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
16:17:14
(UTC-10:00)
Aleutian IslandsSep/21/2020 18:00
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-28-2020
11:53:33
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/23/2020 07:
30New
Information
Sep-28-2020
04:44:18
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Sep-25-2020
14:34:17
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Answered Original value
is correct
Sep-25-2020
12:06:44
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Opened ClinQuery:
Please verify if
Body Aches is
truly ongoing,
then update the
END DATE
and
OUTCOME as
appropriate.
090177e196ae2fda\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-2021-5683-0945625
Page 173 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-22-2020
16:17:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-22-2020
16:17:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Sep-22-2020
16:17:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae2fda\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-2021-5683-0945626
Page 174 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-22-2020
16:17:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-22-2020
16:17:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-22-2020
16:17:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-22-2020
16:17:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae2fda\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-2021-5683-0945627
Page 175 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-22-2020
16:17:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-28-2020
11:53:42
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-28-2020
11:53:42
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDNew
Information
Sep-28-2020
11:53:33
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE BODY
ACHES:
Response to
"What was the
outcome of this
adverse event?"
is 'Not
Recovered/Not
Resolved' but
AE End
Date/Time is
present.
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945628
Page 176 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-22-2020
16:17:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-22-2020
16:17:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945629
Page 177 of 201
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945630
Page 178 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sep/21/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-28-2020
11:52:45
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/23/2020 07:
30New
Information
Sep-28-2020
04:44:41
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Sep-25-2020
14:34:30
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Answered Original value
is correct
Sep-25-2020
12:07:18
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Opened ClinQuery:
Please verify if
Headache is
truly ongoing,
then update the
END DATE
and
OUTCOME as
appropriate.
090177e196ae2fda\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-2021-5683-0945631
Page 179 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae2fda\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-2021-5683-0945632
Page 180 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae2fda\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-2021-5683-0945633
Page 181 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-28-2020
11:53:08
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-28-2020
11:53:08
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDNew
Information
Sep-28-2020
11:52:45
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE
HEADACHE:
Response to
"What was the
outcome of this
adverse event?"
is 'Not
Recovered/Not
Resolved' but
AE End
Date/Time is
present.
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945634
Page 182 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-22-2020
16:17:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945635
Page 183 of 201
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NAUSEAInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945636
Page 184 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Sep/21/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/21/2020 21:0
0Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae2fda\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-2021-5683-0945637
Page 185 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2fda\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-2021-5683-0945638
Page 186 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-22-2020
16:18:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fda\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-2021-5683-0945639
Page 187 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-10-2020
11:19:53
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Dec-10-2020
11:13:08
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Answered The EDP was
submitted
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945640
Page 188 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Dec-08-2020
12:20:36
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Opened ClinQuery: If
Exposure
During
Pregnancy
occurs in a
subject or
subject's
partner, the
investigator
must report
this to Pfizer
Safety on the
Vaccines SAE
report Form
and an EDP
supplemental
form. Please
confirm the
EDP
supplemental
form was
completed.
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Exposure During P
regnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-04-2020
12:29:06ACV0PFEINFP6000  Data Entry:
Nov/13/2020 18:00Initial Entry
090177e196ae2fda\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-2021-5683-0945641
Page 189 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00)
Aleutian Islands
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-09-2021
12:05:33
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/23/2020 12:
00New
Information
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-08-2020
12:19:37
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Dec-08-2020
12:07:48
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Dec-08-2020
12:07:38ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dTranscription
Error
090177e196ae2fda\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-2021-5683-0945642
Page 190 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00)
Aleutian Islands
Dec-08-2020
12:07:38
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry: Transcription
Error
Dec-08-2020
10:21:42
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Opened ClinQuery:
Toxicity grade
is noted as 1.
However, per
Safety Related
update, the
grade for EDP
should be
entered as Not
Applicable.
Please review
and update as
appropriate.
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
090177e196ae2fda\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-2021-5683-0945643
Page 191 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
prevent above outcomes).
Date Location User Value Reason
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study
treatment(s), this event
is due to:
OTHER
If Other, specify:
ConceptionInitial Entry
090177e196ae2fda\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-2021-5683-0945644
Page 192 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-10-2021
22:47:19
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 2: Reiss
ued:CandidateFor Clinical review
090177e196ae2fda\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-2021-5683-0945645
Page 193 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Mar-10-2021
17:27:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 2: Answ
eredNew information
was known and
Subject is no longer
pregnant
Mar-09-2021
22:04:20
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 2: Reiss
ued:OpenedPer 3 Nov EDP
guidance , outcome
should be recorded
as UNKNOWN.
Please confirm and
update accordingly.
Mar-09-2021
12:05:10
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 2: Answ
eredNew Information
Mar-09-2021
12:05:10
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
RECOVERED
/RESOLVEDNew Information
Mar-08-2021
18:30:27
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 2: Open
edSAE RECON:
AER#2020481520,
the outcome in AE
CRF was reported
as NOT
RECOVERED/NOT
RESOLVED. Per 3
Nov EDP guidance ,
outcome should be
recorded as
UNKNOWN.
Please confirm and
090177e196ae2fda\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-2021-5683-0945646
Page 194 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
update accordingly.
Dec-07-2020
21:11:33
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Close
dResponse satisfies
query
Dec-07-2020
10:25:40
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredAnswer Auto Query
Dec-07-2020
10:25:40
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOT RECOV
ERED/NOT R
ESOLVEDChanged
Information
Dec-06-2020
19:48:14
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Reiss
ued:OpenedResponse does not
satisfy query. AE is
marked as Ongoing
but Outcome of AE
is completed. Please
review and correct.
Dec-04-2020
12:31:12
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Query 1: Answ
eredOriginal value is
correct
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto query
(autoquery)Query 1: Open
edFor AE Exposure
During Pregnancy:
Response to "What
was the outcome of
this adverse event?"
is 'Unknown' but
090177e196ae2fda\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-2021-5683-0945647
Page 195 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
End Date/Time is
provided or "Is the
adverse event still
ongoing?" is marked
"Yes".
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
UNKNOWNInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-04-2020
12:29:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0945648
Page 196 of 201
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-17-2020
18:01:56
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945649
Page 197 of 201
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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
Dec-17-2020
18:02:07
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Participant is willing
to return for Vaccina
tion 3
Participant is:
eligible and NOT
confirmed to hav
e received only pl
acebo at Vaccinat
ion 1/2Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945650
Page 198 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-17-2020
18:01:46
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-17-2020
18:01:46
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945651
Page 199 of 201
***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: 11771222 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
08:55:48
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-01-2020
09:21:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-01-2020
09:18:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-19-2020
08:55:48
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/19/2020Initial Entry
Sep-01-2020
09:21:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/1/2020Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945652
Page 200 of 201
***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: 11771222 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-01-2020
09:18:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/1/2020Initial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945653
Page 201 of 201
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771222 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
16:05:36
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2fda\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945654
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