125742 S1 M5 CRF c4591001 1022 10221108

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
172
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900012
Page 2 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/2/2020
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900013
Page 3 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10221108]
2.Birth Date: /1969
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900014
Page 4 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900015
Page 5 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900016
Page 6 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900017
Page 7 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Cholecystectomy]
Start Date: Jun/1/2020
Ongoing: NO
End Date:
Jun/1/2020
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Gallstones]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
Jun/1/2020
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900018
Page 8 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [217.2]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [29.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900019
Page 9 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [78321]
3.Randomization Group: [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900020
Page 10 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BPHDNS]
5.bSample ID [BPHDNT]
5.cSample ID [BMB619]
5.dSample ID [BMB61B]
5.eSample ID [BMB61C]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900021
Page 11 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BMB62F]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900022
Page 12 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/2/2020 09:46
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
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900023
Page 13 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900024
Page 14 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900025
Page 15 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900026
Page 16 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
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 [BP1BNM]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900027
Page 17 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/22/2020 10:08
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
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900028
Page 18 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900029
Page 19 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BM94LN]
5.bSample ID [BPHF2J]
5.cSample ID [BPHF2T]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900030
Page 20 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900031
Page 21 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900032
Page 22 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900033
Page 23 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900034
Page 24 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900035
Page 25 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900036
Page 26 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900037
Page 27 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900038
Page 28 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900039
Page 29 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900040
Page 30 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900041
Page 31 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900042
Page 32 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900043
Page 33 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900044
Page 34 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900045
Page 35 of 172
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900046
Page 36 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900047
Page 37 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900048
Page 38 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900049
Page 39 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900050
Page 40 of 172
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Mild Injection
site pain Sep/2/2020
10:00 NO
End Date Time:
Sep/3/2020 16:00
 Repeating
Pages
 2.ADVERSE
EVENT 2  Moderate Myal
gias Sep/22/202
0 16:00 NO
End Date Time:
Sep/24/2020 07:00
 Repeating
Pages
 3.ADVERSE
EVENT 3  Moderate Head
ache Sep/22/202
0 16:00 NO
End Date Time:
Sep/24/2020 07:00
 Repeating
Pages
 4.ADVERSE
EVENT 4  Moderate Chill
s Sep/23/202
0 07:00 NO
End Date Time:
Sep/24/2020 07:00
 Repeating
Pages
 5.ADVERSE
EVENT 5  Left Axillary A
denopathy Sep/24/202
0 07:00 NO
End Date Time:
Sep/28/2020 UNK:
UNK
 Repeating
Pages
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900051
Page 41 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Mild Injection site pain]
4.Start Date Time: Sep/2/2020 10:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/3/2020 16:00
6.Toxicity Grade: 1
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900052
Page 42 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900053
Page 43 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900054
Page 44 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Moderate Myalgias]
4.Start Date Time: Sep/22/2020 16:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/24/2020 07:00
6.Toxicity Grade: 2
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900055
Page 45 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900056
Page 46 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900057
Page 47 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Moderate Headache]
4.Start Date Time: Sep/22/2020 16:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/24/2020 07:00
6.Toxicity Grade: 2
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900058
Page 48 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900059
Page 49 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900060
Page 50 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Moderate Chills]
4.Start Date Time: Sep/23/2020 07:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/24/2020 07:00
6.Toxicity Grade: 2
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900061
Page 51 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900062
Page 52 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900063
Page 53 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Left Axillary Adenopathy]
4.Start Date Time: Sep/24/2020 07:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/28/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900064
Page 54 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900065
Page 55 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900066
Page 56 of 172
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900067
Page 57 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900068
Page 58 of 172
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.1  VACCINATI
ONS NO  Shingrix  Oct/15/
2020 Repeating
Pages
 2.2  VACCINATI
ONS NO  Flu Shot  Oct/15/
2020 Repeating
Pages
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900069
Page 59 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Shingrix]
5.Date: Oct/15/2020
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900070
Page 60 of 172
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[2]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Flu Shot]
5.Date: Oct/15/2020
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900071
Page 61 of 172
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900072
Page 62 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900073
Page 63 of 172
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900074
Page 64 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900075
Page 65 of 172
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900076
Page 66 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900077
Page 67 of 172
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900078
Page 68 of 172
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900079
Page 69 of 172
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900080
Page 70 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900081
Page 71 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900082
Page 72 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900083
Page 73 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900084
Page 74 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900085
Page 75 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900086
Page 76 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900087
Page 77 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900088
Page 78 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900089
Page 79 of 172
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900090
Page 80 of 172
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900091
Page 81 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/20/2020
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900092
Page 82 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900093
Page 83 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-09-2021 13:48:02 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900094
Page 84 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-02-2020 09:34:31 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900095
Page 85 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-09-2021 13:48:02 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-09-2021 10:02:47 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-10-2020 09:02:20 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900096
Page 86 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Nov-09-2020 10:35:36 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-02-2020 13:32:52 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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.
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900097
Page 87 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
 N/A Nov-02-2020 09:18:53 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-26-2020 07:59:46 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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.
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900098
Page 88 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-02-2020
09:33:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-02-2020
09:33:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900099
Page 89 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-02-2020
09:33:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/2/2020Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900100
Page 90 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-02-2020
09:32:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10221108Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-02-2020
09:32:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1969Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-02-2020
09:34:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900101
Page 91 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-02-2020
09:34:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-02-2020
09:34:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900102
Page 92 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020
09:34:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900103
Page 93 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-02-2020
09:35:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-02-2020
09:35:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-02-2020
09:35:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900104
Page 94 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-02-2020
10:29:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:1
Medical
History T
erm:Cholecy
stectomy
Start Dat
e:Jun/1/20
20
Ongoing: NO
End D
ate:
Jun/1
/2020Transcription
Error
Sep-02-2020
09:37:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:1
Medica
l Histor
y Term
:Gallbladde
r Cholecys
tectomy
Start D
ate:Jun/1/2020Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900105
Page 95 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoin
g:NO
End Date
:
Jun/1/2
020
1.a Line/MH Number:
Date Location User Value Reason
Sep-02-2020
09:37:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
10:29:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CholecystectomyTranscription
Error
Sep-02-2020
09:37:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Gallbladder Cholec
ystectomyInitial Entry
1.a Start Date:
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900106
Page 96 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-02-2020
09:37:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jun/1/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-02-2020
09:37:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/1/2020Initial Entry
1.b
Date Location User Value Reason
Sep-02-2020
10:26:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:2
Medical
History T
erm:Gallston
es
Start Dat
e:UNK/U
NK/201
8Transcription
Error
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900107
Page 97 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End D
ate:
Jun/1
/2020
Sep-02-2020
10:26:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Numb
er:2
Medical
History
Term:Gallstone
s
Start Da
te:UNK/UN
K/2018
Ongoing
:NO
End Dat
e:
UNK/
UNK/
2020Transcription
Error
Sep-02-2020
09:38:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:2
Medical
History
Term:Gallstone
s
Start Da
te:UNK/UN
K/2020Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900108
Page 98 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing
:NO
End Dat
e:
UNK/
UNK/
2020
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900109
Page 99 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-02-2020
09:38:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
09:38:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
GallstonesInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-02-2020
10:26:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-02-2020
10:26:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Transcription
Error
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900110
Page 100 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-02-2020
09:59:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is
after or equal
to the first
vaccination
date 02/Sep
/2020. Please
review and
update as
appropriate.
Sep-02-2020
09:38:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-02-2020
10:26:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/1/2020Transcription
Error
Sep-02-2020
09:38:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2020Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900111
Page 101 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020
09:38:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-02-2020
09:38:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
217.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-02-2020
09:38:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900112
Page 102 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-02-2020
09:38:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-02-2020
09:38:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-02-2020
09:38:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.5Initial Entry
7.a
Date Location User Value Reason
Sep-02-2020
09:38:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.0Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900113
Page 103 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-02-2020
09:38:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-02-2020
09:38:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-02-2020
09:38:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900114
Page 104 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Temperature Location:
Date Location User Value Reason
Sep-02-2020
09:38:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900115
Page 105 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-02-2020
09:59:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-02-2020
09:59:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
78321Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900116
Page 106 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020
07:19:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020
07:19:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020
07:19:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-03-2020
07:19:48
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900117
Page 107 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-03-2020
07:19:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020
07:19:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPHDN
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020
07:19:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHDNSInitial Entry
5.b
Date Location User Value Reason
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900118
Page 108 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-03-2020
07:20:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPHDN
TInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-03-2020
07:20:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHDNTInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020
07:20:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BMB61
9Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-03-2020
07:20:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMB619Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900119
Page 109 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d
Date Location User Value Reason
Sep-03-2020
07:20:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BMB61
BInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-03-2020
07:20:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMB61BInitial Entry
5.e
Date Location User Value Reason
Sep-03-2020
07:20:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BMB61
CInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900120
Page 110 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.e Sample ID
Date Location User Value Reason
Sep-03-2020
07:20:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMB61CInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900121
Page 111 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020
09:40:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020
09:40:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020
09:41:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-02-2020
09:40:31
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900122
Page 112 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-02-2020
09:40:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020
09:41:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BMB62
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020
09:41:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMB62FInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900123
Page 113 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-02-2020
09:59:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020
09:59:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020
09:59:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900124
Page 114 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-02-2020
09:59:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020 09:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020
09:59:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020
09:59:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-02-2020
09:59:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900125
Page 115 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-02-2020
09:59:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-02-2020
10:29:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900126
Page 116 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-02-2020
09:39:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900127
Page 117 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-22-2020
10:14:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900128
Page 118 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020
10:14:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020
10:14:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.9
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020
10:14:56
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900129
Page 119 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-22-2020
10:14:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020
10:14:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-22-2020
10:14:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900130
Page 120 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020
10:16:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020
10:16:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020
10:17:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-22-2020
10:16:43
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900131
Page 121 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-22-2020
10:16:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-22-2020
10:17:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP1BN
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020
10:17:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP1BNMInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900132
Page 122 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-22-2020
10:15:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020
10:15:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020
10:15:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900133
Page 123 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-22-2020
10:15:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020 10:08Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020
10:15:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-22-2020
10:15:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-22-2020
10:15:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900134
Page 124 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-22-2020
10:15:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-22-2020
10:47:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900135
Page 125 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020
11:52:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900136
Page 126 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020
11:52:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020
11:52:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020
11:52:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-20-2020
11:52:35
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900137
Page 127 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-20-2020
11:52:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020
11:52:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BM94L
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020
11:52:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM94LNInitial Entry
5.b
Date Location User Value Reason
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900138
Page 128 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-20-2020
11:52:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPHF2
JInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020
11:52:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHF2JInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020
11:53:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPHF2
TInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020
11:53:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHF2TInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900139
Page 129 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-20-2020
11:53:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-20-2020
11:53:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-20-2020
11:53:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900140
Page 130 of 172
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Sep-23-2020
09:17:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900141
Page 131 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900142
Page 132 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900143
Page 133 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900144
Page 134 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Sep-25-2020
10:42:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900145
Page 135 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020
09:17:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-23-2020
09:17:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-23-2020
09:17:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mild Injection site pa
inInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900146
Page 136 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-23-2020
09:17:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-23-2020
09:17:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/3/2020 16:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-23-2020
09:17:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900147
Page 137 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-23-2020
09:17:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-23-2020
09:17:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-23-2020
09:17:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-23-2020
09:17:35
(UTC-08:00)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900148
Page 138 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Pacific Time (US
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020
09:17:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-23-2020
09:17:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-23-2020
09:17:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900149
Page 139 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-23-2020
09:17:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900150
Page 140 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Moderate MyalgiasInitial Entry
4. Start Date Time:
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900151
Page 141 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/24/2020 07:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  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
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900152
Page 142 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
prevent above outcomes).
Date Location User Value Reason
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900153
Page 143 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900154
Page 144 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-25-2020
10:38:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900155
Page 145 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Moderate HeadacheInitial Entry
4. Start Date Time:
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900156
Page 146 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/24/2020 07:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  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
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900157
Page 147 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
prevent above outcomes).
Date Location User Value Reason
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900158
Page 148 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900159
Page 149 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-25-2020
10:41:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900160
Page 150 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Moderate ChillsInitial Entry
4. Start Date Time:
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900161
Page 151 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 07:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/24/2020 07:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  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
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900162
Page 152 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
prevent above outcomes).
Date Location User Value Reason
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900163
Page 153 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900164
Page 154 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-25-2020
10:42:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900165
Page 155 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-25-2020
10:42:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-25-2020
10:42:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-25-2020
10:42:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Left Axillary Adenop
athyInitial Entry
4. Start Date Time:
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900166
Page 156 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-25-2020
10:42:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020 07:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-10-2020
01:40:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Juleen
GayedQuery 1: Closed Response
satisfies query
Nov-09-2020
10:35:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Nov-09-2020
10:35:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/28/2020 UN
K:UNKTranscription
Error
Nov-09-2020
07:42:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Juleen
GayedQuery 1: Opened Clin: Please
confirm if this
AE is still
ongoing
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0900167
Page 157 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-25-2020
10:42:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-25-2020
10:42:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Sep-25-2020
10:42:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900168
Page 158 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-25-2020
10:42:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-25-2020
10:42:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-25-2020
10:42:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-25-2020
10:42:58
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900169
Page 159 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-25-2020
10:42:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-09-2020
10:35:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-09-2020
10:35:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDTranscription
Error
Nov-09-2020
10:35:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Left
Axillary
Adenopathy:
Response to
"What was the
outcome of this
adverse event?"
is 'Not
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900170
Page 160 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Recovered/Not
Resolved' but
AE End
Date/Time is
present.
Sep-25-2020
10:42:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  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-25-2020
10:42:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900171
Page 161 of 172
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-02-2020
09:18:53
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900172
Page 162 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-02-2020
09:19:04
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900173
Page 163 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-02-2020
09:18:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-02-2020
09:18:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-02-2020
09:18:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic
name is unknown, enter the full trade or proprietary name. Include clarifying information in
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900174
Page 164 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Nov-02-2020
09:18:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ShingrixInitial Entry
5. Date:
Date Location User Value Reason
Nov-02-2020
09:18:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900175
Page 165 of 172
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-02-2020
09:19:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
2. Category:
Date Location User Value Reason
Nov-02-2020
09:19:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-02-2020
09:19:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900176
Page 166 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
name is unknown, enter the full trade or proprietary name. Include clarifying information in
the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Nov-02-2020
09:19:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Flu ShotInitial Entry
5. Date:
Date Location User Value Reason
Nov-02-2020
09:19:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900177
Page 167 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021
10:49:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/5/2021Transcription
Error
Feb-09-2021
10:02:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900178
Page 168 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-09-2021
10:03:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing
to return for Vaccinati
on 3
Participant is:
eligible and NOT
confirmed to have
received only plac
ebo at Vaccination
1/2Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900179
Page 169 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-09-2021
10:02:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-09-2021
10:02:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900180
Page 170 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-20-2020
11:53:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-02-2020
09:59:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-02-2020
09:35:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-20-2020
11:53:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
Sep-02-2020
09:59:02ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900181
Page 171 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-08:00)
Pacific Time (US
& Canada)
Sep-02-2020
09:35:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900182
Page 172 of 172
***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: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-26-2020
07:48:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f67\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900183
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