Document text
Page 1 of 197
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
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: 10221164 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 version08 SEP 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900387
Page 2 of 197
***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: 10221164 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/17/2020
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900388
Page 3 of 197
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10221164]
2.Birth Date: /1966
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900389
Page 4 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900390
Page 5 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 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
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900391
Page 6 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900392
Page 7 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 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:[Asthma]
Start Date: Aug/25/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: Feb/2/2010
Ongoing: NO
End Date:
UNK/UNK/2019
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tubular Adenoma of colon]
Start Date: Dec/13/2016
Ongoing: NO
End Date:
Dec/13/2016
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Symptomatic Cholethiasis]
Start Date: Aug/27/2019
Ongoing: YES
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900393
Page 8 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post traumatic stress disorder]
Start Date: Jun/24/2011
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: Jul/5/2012
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Menopause]
Start Date: UNK/UNK/2017
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Macrocytosis]
Start Date: Apr/23/2018
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anemia]
Start Date: Aug/3/2020
Ongoing: YES
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900394
Page 9 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900395
Page 10 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
2.Weight: [163.6]
3.Unit: LB
4.Height: [63.0]
5.Unit: in
6.Body Mass Index: [29.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900396
Page 11 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/17/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900397
Page 12 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/17/2020
2.Randomization Number: [88898]
3.Randomization Group: [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900398
Page 13 of 197
***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: 10221164 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/17/2020
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 [BM94JS]
5.bSample ID [BPHDT5]
5.cSample ID [BPHDT6]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900399
Page 14 of 197
***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: 10221164 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/17/2020
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 [BP1BND]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900400
Page 15 of 197
***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: 10221164 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/17/2020 09:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900401
Page 16 of 197
***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: 10221164 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
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900402
Page 17 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900403
Page 18 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900404
Page 19 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/8/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900405
Page 20 of 197
***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: 10221164 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:
Oct/8/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1BRS]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900406
Page 21 of 197
***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: 10221164 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: Oct/8/2020 09:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900407
Page 22 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900408
Page 23 of 197
***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: 10221164 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:
Nov/5/2020
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 [BP1BZ8]
5.bSample ID [BLDF3W]
5.cSample ID [BLDF41]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900409
Page 24 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900410
Page 25 of 197
***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: 10221164 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 [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900411
Page 26 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900412
Page 27 of 197
***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: 10221164 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 [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900413
Page 28 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900414
Page 29 of 197
***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: 10221164 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 [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900415
Page 30 of 197
***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: 10221164 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:
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900416
Page 31 of 197
***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: 10221164 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: [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900417
Page 32 of 197
***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: 10221164 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 [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900418
Page 33 of 197
***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: 10221164 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 [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900419
Page 34 of 197
***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: 10221164 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?
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900420
Page 35 of 197
***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: 10221164 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:
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900421
Page 36 of 197
***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: 10221164 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:
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900422
Page 37 of 197
***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: 10221164 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 [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900423
Page 38 of 197
***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: 10221164 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:
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900424
Page 39 of 197
***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: 10221164 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 [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900425
Page 40 of 197
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900426
Page 41 of 197
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900427
Page 42 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
1. DELETED ADVERSE
EVENT 1 Generalized Myalgias Sep/17/202
0 08:00 NO
End Date Time:
Sep/18/2020 10:0
0
Repeating
Pages
2. DELETED ADVERSE
EVENT 2 Headache Sep/17/202
0 08:00 NO
End Date Time:
Sep/18/2020 10:0
0
Repeating
Pages
3. DELETED ADVERSE
EVENT 3 Nausea Sep/17/202
0 08:00 NO
End Date Time:
Sep/18/2020 10:0
0
Repeating
Pages
4. DELETED ADVERSE
EVENT 4 Moderate Chills Sep/17/202
0 08:00 NO
End Date Time:
Sep/18/2020 10:0
0
Repeating
Pages
5. ADVERSE
EVENT 5 Mild Injection Site Pain Sep/17/202
0 18:00 NO
End Date Time:
Sep/20/2020 UNK
:UNK
Repeating
Pages
6. ADVERSE
EVENT 6 Mild Injection Site Pain Oct/8/2020
10:00 NO
End Date Time:
Oct/9/2020 07:00
Repeating
Pages
7. ADVERSE
EVENT 7 Erythematous Papules a
round injection site Oct/8/2020
12:00 NO
End Date Time:Repeating
Pages
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900428
Page 43 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
Oct/9/2020 07:00
8. ADVERSE
EVENT 8 Moderate left flank pain
Oct/2/2020
08:00 YES Repeating
Pages
9. ADVERSE
EVENT 9 Benign Paroxysmal Posi
tional Vertigo Oct/16/202
0 08:00 YES Repeating
Pages
10. ADVERSE
EVENT 10 IGA Kappa Multiple M
yeloma Nov/27/20
20 14:06 YES Repeating
Pages
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900429
Page 44 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Generalized Myalgias ]
4.Start Date Time: Sep/17/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/18/2020 10:00
6.Toxicity Grade: 2
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
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900430
Page 45 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900431
Page 46 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Headache ]
4.Start Date Time: Sep/17/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/18/2020 10:00
6.Toxicity Grade: 2
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
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900432
Page 47 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900433
Page 48 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Nausea]
4.Start Date Time: Sep/17/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/18/2020 10:00
6.Toxicity Grade: 2
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
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900434
Page 49 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900435
Page 50 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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/17/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/18/2020 10:00
6.Toxicity Grade: 2
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
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900436
Page 51 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900437
Page 52 of 197
***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: 10221164 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)[Mild Injection Site Pain]
4.Start Date Time: Sep/17/2020 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/20/2020 UNK:UNK
6.Toxicity Grade: 1
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
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900438
Page 53 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900439
Page 54 of 197
***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: 10221164 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: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Mild Injection Site Pain]
4.Start Date Time: Oct/8/2020 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/9/2020 07:00
6.Toxicity Grade: 1
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
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900440
Page 55 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900441
Page 56 of 197
***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: 10221164 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: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Erythematous Papules around injection site]
4.Start Date Time: Oct/8/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/9/2020 07:00
6.Toxicity Grade: 1
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
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900442
Page 57 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900443
Page 58 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 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: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Moderate left flank pain]
4.Start Date Time: Oct/2/2020 08:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Musculoskeletal]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900444
Page 59 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900445
Page 60 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 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: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Benign Paroxysmal Positional Vertigo]
4.Start Date Time: Oct/16/2020 08:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Idiopathic]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900446
Page 61 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900447
Page 62 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 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: [10]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[IGA Kappa Multiple Myeloma]
4.Start Date Time: Nov/27/2020 14:06
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900448
Page 63 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Idiopathic]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[2020473629]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900449
Page 64 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
1. Repeating
Pages
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900450
Page 65 of 197
***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: 10221164 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[ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900451
Page 66 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart Da
teForm Instanc
e
1.1 VACCINATIONS
NO Seasonal Flu V
accine Oct/23/2
020 Repeating
Pages
2.2 VACCINATIONS
NO T-Dap Oct/19/2
020 Repeating
Pages
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900452
Page 67 of 197
***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: 10221164 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).[Seasonal Flu Vaccine]
5.Date: Oct/23/2020
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900453
Page 68 of 197
***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: 10221164 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).[T-Dap]
5.Date: Oct/19/2020
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900454
Page 69 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900455
Page 70 of 197
***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: 10221164 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?
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900456
Page 71 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatme
ntStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900457
Page 72 of 197
***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: 10221164 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?
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900458
Page 73 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900459
Page 74 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900460
Page 75 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900461
Page 76 of 197
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900462
Page 77 of 197
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 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:
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900463
Page 78 of 197
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900464
Page 79 of 197
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 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?
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900465
Page 80 of 197
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900466
Page 81 of 197
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900467
Page 82 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900468
Page 83 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900469
Page 84 of 197
***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: 10221164 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 [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900470
Page 85 of 197
***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: 10221164 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 [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900471
Page 86 of 197
***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: 10221164 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: [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900472
Page 87 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/14/2020
2.Erroneous Visit
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900473
Page 88 of 197
***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: 10221164 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
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900474
Page 89 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/15/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900475
Page 90 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900476
Page 91 of 197
***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: 10221164 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: [ ]
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900477
Page 92 of 197
***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: 10221164 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 Nov/5/2020
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900478
Page 93 of 197
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 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
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900479
Page 94 of 197
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 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 15:26:43 (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.
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900480
Page 95 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-17-2020 10:27:11 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900481
Page 96 of 197
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 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 15:26:43 (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 10:28:03 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 08:43:50 (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 Nov-30-2020 13:17:43 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900482
Page 97 of 197
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
N/A
Approved Nov-10-2020 15:40:52 (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.
N/A Nov-10-2020 09:41:31 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-10-2020 09:13:22 (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.
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900483
Page 98 of 197
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - 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: 10221164 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-17-2020 10:26:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-17-2020 10:26:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900484
Page 99 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-17-2020 10:26:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Sep/17/2020Initial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900485
Page 100 of 197
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - 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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-17-2020 10:26:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10221164Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-17-2020 10:26:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1966Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-17-2020 10:26:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-17-2020 10:26:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-17-2020 10:26:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900486
Page 101 of 197
***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: 10221164 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-17-2020 10:27:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900487
Page 102 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 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-17-2020 10:27:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-17-2020 10:27:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-17-2020 10:27:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900488
Page 103 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-17-2020 10:27:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Asthma
Start Date: Aug/25/20
10
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-17-2020 10:27:40
(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-17-2020 10:27:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AsthmaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-17-2020 10:27:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-17-2020 10:27:40
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f68\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-2021-5683-0900489
Page 104 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
1.b
Date Location User Value Reason
Oct-26-2020 07:28:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:2
Medical Histo
ry Term:Obesity
Start Date: Feb/2/2010
Ongoing: NO
End Date:
UNK/UN
K/2019New Information
Sep-17-2020 10:28:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Obesity
Start Date: Feb/2/20
10
Ongoing: YESInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0900490
Page 105 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-17-2020 10:28:06
(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-17-2020 10:28:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ObesityInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-17-2020 10:28:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/2/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-27-2020 18:11:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-26-2020 07:28:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-26-2020 07:28:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2019New Information
Oct-26-2020 00:51:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: There
is an inconsistency
between the
Medical History
and the BMI value
090177e196ae2f68\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), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0900491
Page 106 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
at Visit 1, the
Medical Hx has an
entry of Obesity
that is Ongoing,
however the BMI
value is less than
30, Please clarity
the entry of
Obesity and update
CRF entry.
Oct-25-2020 18:10:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate ClinQuery: There
is an inconsistency
between the
Medical History
and the BMI value
at Visit 1, the
Medical Hx has an
entry of Obesity
that is Ongoing,
however the BMI
value is less than
30, Please clarity
the entry of
Obesity and update
CRF entry.
Sep-17-2020 10:28:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-28-2020 07:40:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Tubular Adeno
ma of colon
Start Date: Dec/13/2016Transcription Error
090177e196ae2f68\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-2021-5683-0900492
Page 107 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
Dec/13/2016
Oct-28-2020 07:35:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Tubular Adeno
ma of colon
Start Date: Dec/13/2016
Ongoing: NO
End Date:
UNK/UNK/
2017Transcription Error
Sep-17-2020 10:28:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Tubular Adeno
ma of colon
Start Date: Dec/13/2016
Ongoing: YESInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900493
Page 108 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Sep-17-2020 10:28:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 10:28:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Tubular Adenoma of colonInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-17-2020 10:28:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/13/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Nov-01-2020 16:57:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-28-2020 07:40:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/13/2016Transcription Error
Oct-28-2020 07:35:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-28-2020 07:35:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Transcription Error
090177e196ae2f68\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900494
Page 109 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-27-2020 18:31:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
confirm if this is
still ongoing
Sep-17-2020 10:28:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-17-2020 10:28:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:Symptomatic C
holethiasis
Start Date: Aug/27/2019
Ongoing: YESInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900495
Page 110 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Sep-17-2020 10:28:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 10:28:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptomatic CholethiasisInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-17-2020 10:28:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-17-2020 10:28:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-17-2020 10:30:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Hist
ory Term:Post traumatic st
ress disorder
Start Date: Jun/24/2011
Ongoing: YESInitial Entry
090177e196ae2f68\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-2021-5683-0900496
Page 111 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Sep-17-2020 10:30:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 10:30:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Post traumatic stress disorderInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-17-2020 10:30:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/24/2011Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-17-2020 10:30:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-17-2020 10:30:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:Depressio
n
Start Date: Jul/5/201
2
Ongoing: YESInitial Entry
090177e196ae2f68\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-2021-5683-0900497
Page 112 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Sep-17-2020 10:30:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 10:30:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DepressionInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-17-2020 10:30:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/5/2012Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-17-2020 10:30:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-17-2020 10:30:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:Menopause
Start Date: UNK/UNK/
2017
Ongoing: YESInitial Entry
090177e196ae2f68\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-2021-5683-0900498
Page 113 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Sep-17-2020 10:30:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 10:30:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MenopauseInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-17-2020 10:30:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-17-2020 10:30:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Nov-30-2020 13:17:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Te
rm:Macrocyto
sis
Start Date: Apr/23/20
18
Ongoing: YESInitial Entry
090177e196ae2f68\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-2021-5683-0900499
Page 114 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.h Line/MH Number:
Date Location User Value Reason
Nov-30-2020 13:17:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-30-2020 13:17:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MacrocytosisInitial Entry
1.h Start Date:
Date Location User Value Reason
Nov-30-2020 13:17:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/23/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Nov-30-2020 13:17:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Nov-30-2020 13:18:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Te
rm:Anemia
Start Date: Aug/3/20
20
Ongoing: YESInitial Entry
090177e196ae2f68\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-2021-5683-0900500
Page 115 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Nov-30-2020 13:18:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-30-2020 13:18:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AnemiaInitial Entry
1.i Start Date:
Date Location User Value Reason
Nov-30-2020 13:18:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/3/2020Initial Entry
1.i Ongoing:
Date Location User Value Reason
Nov-30-2020 13:18:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f68\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-2021-5683-0900501
Page 116 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-17-2020 10:31:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to b
e HIV POSITIVEInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900502
Page 117 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020 10:31:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-17-2020 10:31:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
163.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-17-2020 10:31:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-17-2020 10:31:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
63.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-17-2020 10:31:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2f68\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900503
Page 118 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-17-2020 10:31:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.0Initial Entry
7.a
Date Location User Value Reason
Sep-17-2020 10:31:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 98.1
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-17-2020 10:31:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-17-2020 10:31:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-17-2020 10:31:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2f68\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-2021-5683-0900504
Page 119 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-17-2020 10:31:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900505
Page 120 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-17-2020 10:31:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-17-2020 10:31:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-17-2020 10:31:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-17-2020 10:31:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-17-2020 10:31:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900506
Page 121 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-17-2020 10:31:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-17-2020 10:31:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-17-2020 10:31:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Sep-17-2020 10:31:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900507
Page 122 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-17-2020 10:31:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-17-2020 10:31:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
88898Initial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900508
Page 123 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020 13:40:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 13:40:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 13:40:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 13:40:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-17-2020 13:40:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900509
Page 124 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-17-2020 13:40:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM94JSInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 13:40:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM94JSInitial Entry
5.b
Date Location User Value Reason
Sep-17-2020 13:40:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHDT5Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-17-2020 13:40:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHDT5Initial Entry
5.c
Date Location User Value Reason
Sep-17-2020 13:41:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHDT6Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-17-2020 13:41:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHDT6Initial Entry
090177e196ae2f68\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),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900510
Page 125 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020 10:32:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 10:32:53
(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-17-2020 10:33:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 10:32:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-17-2020 10:32:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900511
Page 126 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-17-2020 10:33:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1BNDInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 10:33:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1BNDInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900512
Page 127 of 197
***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: 10221164 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-17-2020 10:32:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020 10:32:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020 10:32:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-17-2020 10:32:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020 09:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020 10:32:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900513
Page 128 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-17-2020 10:32:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-17-2020 10:32:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-17-2020 10:32:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-17-2020 10:32:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900514
Page 129 of 197
***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: 10221164 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-17-2020 10:32:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900515
Page 130 of 197
***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: 10221164 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-08-2020 09:43:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/8/2020Initial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900516
Page 131 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-08-2020 09:43:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/8/2020Initial Entry
2.a
Date Location User Value Reason
Oct-08-2020 09:43:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 98.2
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-08-2020 09:43:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-08-2020 09:43:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-08-2020 09:43:55 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f68\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)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0900517
Page 132 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-08:00) Pacific
Time (US & Canada)F
2.a Temperature Location:
Date Location User Value Reason
Oct-08-2020 09:43:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900518
Page 133 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-08-2020 09:44:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-08-2020 09:44:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-08-2020 09:44:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/8/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-08-2020 09:44:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-08-2020 09:44:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900519
Page 134 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-08-2020 09:44:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-08-2020 09:44:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-08-2020 09:44:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Oct-08-2020 09:44:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900520
Page 135 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020 09:44:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020 09:44:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020 09:44:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-08-2020 09:44:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-08-2020 09:44:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/8/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900521
Page 136 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-08-2020 09:44:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1BRSInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-08-2020 09:44:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1BRSInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900522
Page 137 of 197
***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: 10221164 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
Oct-08-2020 09:45:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-08-2020 09:45:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-08-2020 09:45:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-08-2020 09:45:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/8/2020 09:22Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-08-2020 09:45:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900523
Page 138 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-08-2020 09:45:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-08-2020 09:45:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-08-2020 09:45:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-08-2020 09:57:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900524
Page 139 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020 09:59:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/5/2020Initial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900525
Page 140 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-05-2020 09:59:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-05-2020 09:59:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020 10:00:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-05-2020 09:59:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-05-2020 09:59:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900526
Page 141 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-05-2020 10:00:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1BZ8Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-05-2020 10:00:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1BZ8Initial Entry
5.b
Date Location User Value Reason
Nov-05-2020 10:00:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLDF3WInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-05-2020 10:00:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLDF3WInitial Entry
5.c
Date Location User Value Reason
Nov-05-2020 10:00:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLDF41Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-05-2020 10:00:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLDF41Initial Entry
090177e196ae2f68\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),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900527
Page 142 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Sep-23-2020 12:37:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Sep-23-2020 12:28:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900528
Page 143 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Sep-23-2020 12:37:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Sep-23-2020 12:29:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0900529
Page 144 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Sep-23-2020 12:37:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Sep-23-2020 12:29:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900530
Page 145 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Sep-23-2020 12:38:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Sep-23-2020 12:30:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900531
Page 146 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-08-2020 09:46:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900532
Page 147 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900533
Page 148 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-10-2020 09:42:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900534
Page 149 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-10-2020 09:43:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900535
Page 150 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-10-2020 09:44:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900536
Page 151 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-30-2020 13:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900537
Page 152 of 197
***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, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 12:28:22
(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 12:28:22
(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 12:28:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Generalized MyalgiasInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 12:28:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-23-2020 12:28:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/18/2020 10:00Initial Entry
090177e196ae2f68\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-2021-5683-0900538
Page 153 of 197
***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, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
6. Toxicity Grade:
Date Location User Value Reason
Sep-23-2020 12:28:22
(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 prevent above outcomes).
Date Location User Value Reason
Sep-23-2020 12:28:22
(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 12:28:22
(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 12:28:22
(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 12:28:22
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2f68\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900539
Page 154 of 197
***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, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 12:28:22
(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 12:28:22
(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 12:28:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 12:28:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f68\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900540
Page 155 of 197
***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, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 12:29:01
(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 12:29:01
(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-23-2020 12:29:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HeadacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 12:29:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-23-2020 12:29:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/18/2020 10:00Initial Entry
090177e196ae2f68\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-2021-5683-0900541
Page 156 of 197
***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, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
6. Toxicity Grade:
Date Location User Value Reason
Sep-23-2020 12:29:01
(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 prevent above outcomes).
Date Location User Value Reason
Sep-23-2020 12:29:01
(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 12:29:01
(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 12:29:01
(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 12:29:01
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2f68\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900542
Page 157 of 197
***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, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 12:29:01
(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 12:29:01
(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 12:29:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 12:29:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f68\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900543
Page 158 of 197
***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, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 12:29:34
(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 12:29:34
(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-23-2020 12:29:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NauseaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 12:29:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-23-2020 12:29:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/18/2020 10:00Initial Entry
090177e196ae2f68\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-2021-5683-0900544
Page 159 of 197
***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, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
6. Toxicity Grade:
Date Location User Value Reason
Sep-23-2020 12:29:34
(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 prevent above outcomes).
Date Location User Value Reason
Sep-23-2020 12:29:34
(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 12:29:34
(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 12:29:34
(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 12:29:34
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2f68\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900545
Page 160 of 197
***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, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 12:29:34
(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 12:29:34
(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 12:29:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 12:29:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f68\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), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900546
Page 161 of 197
***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, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 12:30:11
(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 12:30:11
(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-23-2020 12:30:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Moderate ChillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 12:30:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-23-2020 12:30:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/18/2020 10:00Initial Entry
090177e196ae2f68\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-2021-5683-0900547
Page 162 of 197
***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, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
6. Toxicity Grade:
Date Location User Value Reason
Sep-23-2020 12:30:11
(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 prevent above outcomes).
Date Location User Value Reason
Sep-23-2020 12:30:11
(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 12:30:11
(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 12:30:11
(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 12:30:11
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2f68\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900548
Page 163 of 197
***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, Deleted
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 12:30:11
(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 12:30:11
(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 12:30:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 12:30:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f68\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900549
Page 164 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-08-2020 09:46:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-08-2020 09:46:28
(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
Oct-08-2020 09:46:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mild Injection Site PainInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-08-2020 09:46:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-08-2020 09:46:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/20/2020 UNK:UNKInitial Entry
090177e196ae2f68\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-2021-5683-0900550
Page 165 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Toxicity Grade:
Date Location User Value Reason
Oct-08-2020 09:46:28
(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
Oct-08-2020 09:46:28
(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
Oct-08-2020 09:46:28
(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
Oct-08-2020 09:46:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-08-2020 09:46:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2f68\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900551
Page 166 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-08-2020 09:46:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-08-2020 09:46:28
(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
Oct-08-2020 09:46:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-08-2020 09:46:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f68\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-2021-5683-0900552
Page 167 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mild Injection Site PainInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/8/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/9/2020 07:00Initial Entry
090177e196ae2f68\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-2021-5683-0900553
Page 168 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Toxicity Grade:
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2f68\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900554
Page 169 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-10-2020 09:41:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f68\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-2021-5683-0900555
Page 170 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-10-2020 09:42:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-10-2020 09:42:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-10-2020 09:42:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Erythematous Papules around i
njection siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-10-2020 09:42:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/8/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-10-2020 09:42:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/9/2020 07:00Initial Entry
090177e196ae2f68\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-2021-5683-0900556
Page 171 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Toxicity Grade:
Date Location User Value Reason
Nov-10-2020 09:42:25
(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
Nov-10-2020 09:42:25
(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
Nov-10-2020 09:42:25
(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
Nov-10-2020 09:42:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-10-2020 09:42:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2f68\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900557
Page 172 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-10-2020 09:42:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-10-2020 09:42:25
(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-10-2020 09:42:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-10-2020 09:42:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f68\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-2021-5683-0900558
Page 173 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-10-2020 09:43:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-10-2020 09:43:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-10-2020 09:43:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Moderate left flank painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-10-2020 09:43:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-14-2020 05:02:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-12-2020 13:37:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Per PI, still
ongoing.
090177e196ae2f68\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-2021-5683-0900559
Page 174 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-12-2020 13:11:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
confirm moderate
left flank pain is
ongoing
Nov-10-2020 09:43:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-10-2020 09:43:44
(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 prevent above outcomes).
Date Location User Value Reason
Nov-10-2020 09:43:44
(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
Nov-10-2020 09:43:44
(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
Nov-10-2020 09:43:44
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
090177e196ae2f68\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),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900560
Page 175 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
Musculoskeletal
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-10-2020 09:43:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-10-2020 09:43:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-10-2020 09:43:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-10-2020 09:43:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae2f68\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900561
Page 176 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-10-2020 09:43:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900562
Page 177 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-10-2020 09:44:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-10-2020 09:44:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-10-2020 09:44:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Benign Paroxysmal Positional
VertigoInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-10-2020 09:44:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/16/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-10-2020 09:44:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2f68\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-2021-5683-0900563
Page 178 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-10-2020 09:44:50
(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 prevent above outcomes).
Date Location User Value Reason
Nov-10-2020 09:44:50
(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
Nov-10-2020 09:44:50
(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
Nov-11-2020
13:44:57
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clos
edResponse
satisfies query
Nov-11-2020
07:03:29
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredThere is no
other key data
available.
090177e196ae2f68\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), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900564
Page 179 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-11-2020
06:43:31
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Ope
nedPlease review
"If not related
to study
treatment
other" field,
the following
text was
indicated in
the comment
field
[Idiopathic].
Any
symptoms,
AEs or other
key data
should be
collected on
the
appropriate
page. Please
review and
update as
necessary.
Nov-10-2020
09:44:50
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relat
ed to
study
treat
ment(
s), thi
s even
t is du
e to:
OT
HE
RInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0900565
Page 180 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
If
Ot
her
, s
pe
cif
y:
I
d
i
o
p
a
t
h
i
c
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-10-2020 09:44:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-10-2020 09:44:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-10-2020 09:44:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae2f68\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-2021-5683-0900566
Page 181 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Nov-10-2020 09:44:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-10-2020 09:44:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900567
Page 182 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-30-2020 13:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-30-2020 13:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-01-2020 15:08:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-01-2020 07:55:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered This will sent in as it
becomes available to
us. In progress
currently.
Dec-01-2020 07:15:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL - please
send a SAE safety
update with any
presenting
signs/symptoms for
myeloma, including
the past Med history
of microcytosis &
anemia, and
laboratory/imaging
evaluation
information.
090177e196ae2f68\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-2021-5683-0900568
Page 183 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-30-2020 13:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IGA Kappa Multiple Myelo
maInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-30-2020 13:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/27/2020 14:06Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-30-2020 13:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-30-2020 13:45:10
(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 prevent above outcomes).
Date Location User Value Reason
Dec-01-2020 04:44:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-30-2020 13:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE IGA
Kappa Multiple
Myeloma:
Response to "Is
090177e196ae2f68\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-2021-5683-0900569
Page 184 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Nov-30-2020 13:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
NO
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
YESInitial 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
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900570
Page 185 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-30-2020 13:45:10
(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
Nov-30-2020 13:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
IdiopathicInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-30-2020 13:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-30-2020 13:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-30-2020 13:45:10
(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
090177e196ae2f68\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900571
Page 186 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Dec-02-2020
04:36:40
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Dec-02-2020
03:12:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Dec-01-2020
07:55:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVER
ED/NOT RESOL
VEDUnknown is Not present on paper
work that was faxed in. It was left
blank.
Dec-01-2020
07:20:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answer
edQuery is ambiguous
Dec-01-2020
07:19:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE IGA Kappa Multiple
Myeloma: Response to "What was
the outcome of this adverse event?"
is 'Unknown' but End Date/Time is
provided or "Is the adverse event
still ongoing?" is marked "Yes".
Dec-01-2020
07:19:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edTranscription Error
Dec-01-2020
07:19:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNTranscription Error
Dec-01-2020
04:45:08
(UTC-08:00)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020473629,outcome
was reported as UNKNOWN to
090177e196ae2f68\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),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900572
Page 187 of 197
***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
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Pacific Time (US
& Canada)Safety DB however, recorded as
NOT RECOVERED/NOT
RESOLVED on AE CRF. Please
confirm correct outcome. If safety
update is required, please submit a
follow-up form.
Nov-30-2020
13:45:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVER
ED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-30-2020 13:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-01-2020 04:44:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020473629Initial Entry
090177e196ae2f68\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-2021-5683-0900573
Page 188 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-05-2020 13:24:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900574
Page 189 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-05-2020 13:24:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900575
Page 190 of 197
***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: 10221164 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-05-2020 13:24:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-05-2020 13:24:45
(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-05-2020 13:24:45
(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 the Medication text (e.g., Ingredient(s),
route, use, formulation).
Date Location User Value Reason
Nov-05-2020 13:24:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal Flu VaccineInitial Entry
5. Date:
Date Location User Value Reason
Nov-05-2020 13:24:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/23/2020Initial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900576
Page 191 of 197
***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: 10221164 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-05-2020 13:24:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
2. Category:
Date Location User Value Reason
Nov-05-2020 13:24:57
(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-05-2020 13:24:57
(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 the Medication text (e.g., Ingredient(s),
route, use, formulation).
Date Location User Value Reason
Nov-05-2020 13:24:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
T-DapInitial Entry
5. Date:
Date Location User Value Reason
Nov-05-2020 13:24:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900577
Page 192 of 197
***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: 10221164 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
Nov-05-2020 10:00:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-05-2020 10:00:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-05-2020 10:00:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900578
Page 193 of 197
***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: 10221164 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-09-2021 10:28:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/14/2020Initial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900579
Page 194 of 197
***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: 10221164 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 10:28:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible and NOT confirmed
to have received only placeb
o at Vaccination 1/2Initial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900580
Page 195 of 197
***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: 10221164 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-24-2021 12:36:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/15/2020Transcription Error
Feb-09-2021 10:28:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/14/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-09-2021 10:28:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATIO
NInitial Entry
090177e196ae2f68\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-2021-5683-0900581
Page 196 of 197
***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: 10221164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-05-2020 10:00:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-17-2020 10:31:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-17-2020 10:27:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-05-2020 10:00:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/5/2020Initial Entry
Sep-17-2020 10:31:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/17/2020Initial Entry
Sep-17-2020 10:27:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/17/2020Initial Entry
090177e196ae2f68\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900582
Page 197 of 197
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clin
…[truncated]