Document text
Page 1 of 418
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899197
Page 2 of 418
***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: 10221024 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
Aug/18/2020
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899198
Page 3 of 418
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10221024]
2.Birth Date: /1993
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899199
Page 4 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/18/2020
2.Erroneous Visit
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899200
Page 5 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899201
Page 6 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899202
Page 7 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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:[Obesity]
Start Date: Jan/23/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Headaches]
Start Date: Jan/23/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Migraines]
Start Date: May/21/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: Dec/1/2016
Ongoing: YES
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899203
Page 8 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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:[Depression]
Start Date: Jul/6/2018
Ongoing: YES
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899204
Page 9 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/18/2020
2.Weight: [228.0]
3.Unit: LB
4.Height: [68.0]
5.Unit: in
6.Body Mass Index: [34.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899205
Page 10 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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: Aug/18/2020
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:
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899206
Page 11 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/18/2020
2.Randomization Number: [54833]
3.Randomization Group: [ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899207
Page 12 of 418
***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: 10221024 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:
Aug/18/2020
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 [BP1C3W]
5.bSample ID [BP1C3X]
5.cSample ID [BP1C3Y]
5.dSample ID [BPHDHB]
5.eSample ID [BPHDHC]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899208
Page 13 of 418
***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: 10221024 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:
Aug/18/2020
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 [BP1C1S]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899209
Page 14 of 418
***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: 10221024 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: Aug/18/2020 11:30
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
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899210
Page 15 of 418
***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: 10221024 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
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899211
Page 16 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899212
Page 17 of 418
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899213
Page 18 of 418
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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/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:
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899214
Page 19 of 418
***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: 10221024 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/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 [BMB669]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899215
Page 20 of 418
***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: 10221024 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/8/2020 15:55
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
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899216
Page 21 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899217
Page 22 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
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 [BP1BTS]
5.bSample ID [BPHDWR]
5.cSample ID [BPHDXH]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899218
Page 23 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899219
Page 24 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/3/2020
2.Date of First Symptom Started: Nov/1/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/4/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899220
Page 25 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899221
Page 26 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Nov/3/202
0 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899222
Page 27 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Not Complete
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/3/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [Sofia 2 SARS CoV-2 Antigen FIA POC-CLIA-certified]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899223
Page 28 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 10221024 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_SELF
3.Sample Collected? YES
Date of Collection:
Nov/3/2020
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 [RW87270]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899224
Page 29 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 10221024 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Self swab and COVID test done]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899225
Page 30 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899226
Page 31 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899227
Page 32 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899228
Page 33 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Viral Illness (non-COVID)]
Date of Diagnosis:
Nov/3/2020
3.Toxicity Grade: 2
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899229
Page 34 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899230
Page 35 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899231
Page 36 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined Id
entifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899232
Page 37 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899233
Page 38 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899234
Page 39 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899235
Page 40 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899236
Page 41 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one Repeating
Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899237
Page 42 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899238
Page 43 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899239
Page 44 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899240
Page 45 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899241
Page 46 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899242
Page 47 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899243
Page 48 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Nov/3/2020 Record Identifier: Systolic: Diastolic:
1 127 95 Repeating Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899244
Page 49 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/3/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [127]
Diastolic: [95]
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: [87]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899245
Page 50 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899246
Page 51 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899247
Page 52 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899248
Page 53 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899249
Page 54 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899250
Page 55 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
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).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899251
Page 56 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899252
Page 57 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899253
Page 58 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/02/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/2/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899254
Page 59 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/02/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 10221024 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:
Dec/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1BZY]
5.bSample ID [BLDF5H]
5.cSample ID [BLDF5J]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899255
Page 60 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899256
Page 61 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899257
Page 62 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899258
Page 63 of 418
***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: 10221024 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: [ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899259
Page 64 of 418
***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: 10221024 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:
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899260
Page 65 of 418
***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: 10221024 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 [ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899261
Page 66 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Loose Stools Sep/9/2020 18
:00 NO
End Date Time:
Sep/10/2020 14:00
Repeating
Pages
2.ADVERSE E
VENT 2 Axillary Pain Aug/18/2020
20:00 NO
End Date Time:
Aug/21/2020 14:10
Repeating
Pages
3.ADVERSE E
VENT 3 Groin Pain Aug/18/2020
20:00 NO
End Date Time:
Aug/21/2020 14:10
Repeating
Pages
4.ADVERSE E
VENT 4 Lymphadenopathy of Head
(left side) Sep/22/2020 0
8:00 NO
End Date Time:
Nov/3/2020 UNK:UNK
Repeating
Pages
5.ADVERSE E
VENT 5 Mild Injection Site Pain Dec/16/2020
14:00 NO
End Date Time:
Dec/17/2020 14:00
Repeating
Pages
6.ADVERSE E
VENT 6 Fatigue Dec/16/2020
14:00 NO
End Date Time:
Dec/17/2020 16:00
Repeating
Pages
7.ADVERSE E
VENT 7 Generalized Myalgias Jan/5/2021 20
:00 NO
End Date Time:
Jan/6/2021 20:00
Repeating
Pages
8.ADVERSE E
VENT 8 Exacerbation of Headache Jan/5/2021 20
:00 NO
End Date Time:
Jan/6/2021 20:00Repeating
Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899262
Page 67 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
9.ADVERSE E
VENT 9 Mild Chills Jan/5/2021 20
:00 NO
End Date Time:
Jan/6/2021 20:00
Repeating
Pages
10.ADVERSE E
VENT 10 Low Grade Fever Jan/5/2021 20
:00 NO
End Date Time:
Jan/6/2021 20:00
Repeating
Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899263
Page 68 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Loose Stools]
4.Start Date Time: Sep/9/2020 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/10/2020 14:00
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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899264
Page 69 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899265
Page 70 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Axillary Pain]
4.Start Date Time: Aug/18/2020 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/21/2020 14:10
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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899266
Page 71 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899267
Page 72 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Groin Pain]
4.Start Date Time: Aug/18/2020 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/21/2020 14:10
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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899268
Page 73 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899269
Page 74 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Lymphadenopathy of Head (left side)]
4.Start Date Time: Sep/22/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/3/2020 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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899270
Page 75 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899271
Page 76 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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: Dec/16/2020 14:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/17/2020 14:00
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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899272
Page 77 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899273
Page 78 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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)[Fatigue]
4.Start Date Time: Dec/16/2020 14:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/17/2020 16:00
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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899274
Page 79 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899275
Page 80 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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)[Generalized Myalgias]
4.Start Date Time: Jan/5/2021 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/6/2021 20:00
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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899276
Page 81 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899277
Page 82 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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)[Exacerbation of Headache]
4.Start Date Time: Jan/5/2021 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/6/2021 20:00
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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899278
Page 83 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899279
Page 84 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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)[Mild Chills]
4.Start Date Time: Jan/5/2021 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/6/2021 20:00
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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899280
Page 85 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899281
Page 86 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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)[Low Grade Fever]
4.Start Date Time: Jan/5/2021 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/6/2021 20:00
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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899282
Page 87 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899283
Page 88 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899284
Page 89 of 418
***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: 10221024 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[ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899285
Page 90 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899286
Page 91 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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.Date: //
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899287
Page 92 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899288
Page 93 of 418
***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: 10221024 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?
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899289
Page 94 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899290
Page 95 of 418
***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: 10221024 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?
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899291
Page 96 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899292
Page 97 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899293
Page 98 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899294
Page 99 of 418
***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: 10221024 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:
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899295
Page 100 of 418
***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: 10221024 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:
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899296
Page 101 of 418
***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: 10221024 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?
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899297
Page 102 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899298
Page 103 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899299
Page 104 of 418
***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: 10221024 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
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899300
Page 105 of 418
***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: 10221024 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 per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899301
Page 106 of 418
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899302
Page 107 of 418
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/16/2020
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899303
Page 108 of 418
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899304
Page 109 of 418
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death :Dec/16/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899305
Page 110 of 418
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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: Dec/16/2020
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:
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899306
Page 111 of 418
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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:
Dec/16/2020
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 [BLDF62]
5.bSample ID [BLDF6L]
5.cSample ID [BM94MY]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899307
Page 112 of 418
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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:
Dec/16/2020
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 [BP1BSV]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899308
Page 113 of 418
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Dec/16/2020 12:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899309
Page 114 of 418
***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: 10221024 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
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899310
Page 115 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899311
Page 116 of 418
***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: 10221024 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: [ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899312
Page 117 of 418
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899313
Page 118 of 418
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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: Jan/5/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899314
Page 119 of 418
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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:
Jan/5/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM94RR]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899315
Page 120 of 418
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/5/2021 08:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899316
Page 121 of 418
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: 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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899317
Page 122 of 418
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/2/2021
3.Comments: [ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899318
Page 123 of 418
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899319
Page 124 of 418
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899320
Page 125 of 418
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899321
Page 126 of 418
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899322
Page 127 of 418
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Feb/2/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899323
Page 128 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/6/2020
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899324
Page 129 of 418
***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: 10221024 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
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899325
Page 130 of 418
***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: 10221024 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 08:36:43 (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.
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899326
Page 131 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-18-2020 11:38:53 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899327
Page 132 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-03-2020 14:16:31 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899328
Page 133 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-03-2020 14:16:31 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899329
Page 134 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-03-2020 14:16:31 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899330
Page 135 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-03-2020 14:16:31 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899331
Page 136 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-03-2020 14:16:31 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899332
Page 137 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Nov-03-2020 14:16:31 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899333
Page 138 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Nov-03-2020 14:16:31 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899334
Page 139 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-03-2020 14:17:12 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899335
Page 140 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-03-2020 14:17:12 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899336
Page 141 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-03-2020 14:17:12 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899337
Page 142 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-03-2020 14:17:12 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899338
Page 143 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-03-2020 14:17:12 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899339
Page 144 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899340
Page 145 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899341
Page 146 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899342
Page 147 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899343
Page 148 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899344
Page 149 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899345
Page 150 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899346
Page 151 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899347
Page 152 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899348
Page 153 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899349
Page 154 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899350
Page 155 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899351
Page 156 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899352
Page 157 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899353
Page 158 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899354
Page 159 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899355
Page 160 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899356
Page 161 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899357
Page 162 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899358
Page 163 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899359
Page 164 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899360
Page 165 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899361
Page 166 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899362
Page 167 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899363
Page 168 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899364
Page 169 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899365
Page 170 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899366
Page 171 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899367
Page 172 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899368
Page 173 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899369
Page 174 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899370
Page 175 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899371
Page 176 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-03-2020 14:18:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899372
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899373
Page 178 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899374
Page 179 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899375
Page 180 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899376
Page 181 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899377
Page 182 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899378
Page 183 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899379
Page 184 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899380
Page 185 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899381
Page 186 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899382
Page 187 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899383
Page 188 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899384
Page 189 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899385
Page 190 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899386
Page 191 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899387
Page 192 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899388
Page 193 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899389
Page 194 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899390
Page 195 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899391
Page 196 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899392
Page 197 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899393
Page 198 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899394
Page 199 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899395
Page 200 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899396
Page 201 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899397
Page 202 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899398
Page 203 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899399
Page 204 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899400
Page 205 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899401
Page 206 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899402
Page 207 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899403
Page 208 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899404
Page 209 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899405
Page 210 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899406
Page 211 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899407
Page 212 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899408
Page 213 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899409
Page 214 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899410
Page 215 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899411
Page 216 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899412
Page 217 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899413
Page 218 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899414
Page 219 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899415
Page 220 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899416
Page 221 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jNov-03-2020 14:18:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899417
Page 222 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aNov-04-2020 10:35:47 (UTC-08:00) Pacific
Time (US & Canada)Respiratory rate was not collected
Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899418
Page 223 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-03-2020 14:19:47 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899419
Page 224 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-03-2020 14:19:47 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899420
Page 225 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aNov-03-2020 14:19:47 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899421
Page 226 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-03-2020 14:20:03 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899422
Page 227 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-03-2020 14:20:03 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899423
Page 228 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-03-2020 14:20:03 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899424
Page 229 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-03-2020 14:20:03 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899425
Page 230 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-03-2020 14:20:16 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899426
Page 231 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-03-2020 14:20:16 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899427
Page 232 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-03-2020 14:20:16 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899428
Page 233 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-03-2020 14:20:16 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899429
Page 234 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-03-2020 14:20:16 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899430
Page 235 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Nov-03-2020 14:20:16 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899431
Page 236 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Nov-03-2020 14:20:16 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899432
Page 237 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-03-2020 14:20:32 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899433
Page 238 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-03-2020 14:20:32 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899434
Page 239 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-03-2020 14:20:32 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899435
Page 240 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-03-2020 14:20:32 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899436
Page 241 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-03-2020 14:20:32 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899437
Page 242 of 418
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormDec-16-2020 13:15:47 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899438
Page 243 of 418
***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: 10221024 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 08:36:43 (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-02-2021 09:22:59 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 07:51:10 (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 10:22:04 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f69\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-2021-5683-0899439
Page 244 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Approved Nov-05-2020 08:44:28 (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-03-2020 14:10:10 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-20-2020 14:34:04 (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.
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899440
Page 245 of 418
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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
Aug-18-2020 11:38:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-18-2020 11:38:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899441
Page 246 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-18-2020 11:38:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/18/2020Initial Entry
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899442
Page 247 of 418
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-18-2020 11:38:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10221024Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-18-2020 11:38:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1993Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-18-2020 11:38:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-18-2020 11:38:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-18-2020 11:38:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f69\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-2021-5683-0899443
Page 248 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-18-2020 11:38:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899444
Page 249 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 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
Aug-18-2020 11:39:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-18-2020 11:39:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-18-2020 11:39:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899445
Page 250 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-18-2020 11:39:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Obesity
Start Date: Jan/23/201
7
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-18-2020 11:39:45
(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
Aug-18-2020 11:39:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ObesityInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-18-2020 11:39:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/23/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-18-2020 11:39:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae2f69\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-2021-5683-0899446
Page 251 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-18-2020 11:40:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:Headaches
Start Date: Jan/23/201
7
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-18-2020 11:40:07
(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
Aug-18-2020 11:40:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HeadachesInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-18-2020 11:40:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/23/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-18-2020 11:40:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-18-2020 11:40:33
(UTC-08:00) Pacific TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196ae2f69\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-2021-5683-0899447
Page 252 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) Medical History Ter
m:Migraines
Start Date: May/21/201
8
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-18-2020 11:40:33
(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
Aug-18-2020 11:40:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MigrainesInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-18-2020 11:40:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/21/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-18-2020 11:40:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-18-2020 11:40:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:AnxietyInitial Entry
090177e196ae2f69\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-2021-5683-0899448
Page 253 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: Dec/1/201
6
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-18-2020 11:40:56
(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
Aug-18-2020 11:40:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AnxietyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-18-2020 11:40:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/1/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-18-2020 11:40:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-18-2020 11:41:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Term
:Depressio
n
Start Date: Jul/6/2018
Ongoing: YESInitial Entry
090177e196ae2f69\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-2021-5683-0899449
Page 254 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-18-2020 11:41:09
(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
Aug-18-2020 11:41:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DepressionInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-18-2020 11:41:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/6/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-18-2020 11:41:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f69\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-2021-5683-0899450
Page 255 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-18-2020 11:41:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-18-2020 11:41:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
228.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-18-2020 11:41:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-18-2020 11:41:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
68.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-18-2020 11:41:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-18-2020 11:41:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
34.7Initial Entry
090177e196ae2f69\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-2021-5683-0899451
Page 256 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a
Date Location User Value Reason
Aug-18-2020 11:41:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.8
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-18-2020 11:41:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-18-2020 11:41:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-18-2020 11:41:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-18-2020 11:41:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f69\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-2021-5683-0899452
Page 257 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-18-2020 11:42:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-18-2020 11:42:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-18-2020 11:42:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-18-2020 11:42:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-18-2020 11:42:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-18-2020 11:42:12
(UTC-08:00) Pacific TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899453
Page 258 of 418
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-18-2020 11:42:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-18-2020 11:42:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-18-2020 11:42:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899454
Page 259 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-18-2020 11:43:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-18-2020 11:43:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
54833Initial Entry
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899455
Page 260 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-18-2020 11:53:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020 11:53:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-18-2020 11:53:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-18-2020 11:53:07
(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.
Aug-18-2020 11:53:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-18-2020 11:53:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1C3WInitial Entry
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899456
Page 261 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-18-2020 11:53:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1C3WInitial Entry
5.b
Date Location User Value Reason
Aug-18-2020 11:53:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1C3XInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-18-2020 11:53:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1C3XInitial Entry
5.c
Date Location User Value Reason
Aug-18-2020 11:53:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1C3YInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-18-2020 11:53:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1C3YInitial Entry
5.d
Date Location User Value Reason
Aug-18-2020 11:53:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHDHBInitial Entry
090177e196ae2f69\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-2021-5683-0899457
Page 262 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Aug-18-2020 11:53:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHDHBInitial Entry
5.e
Date Location User Value Reason
Aug-18-2020 11:53:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHDHCInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-18-2020 11:53:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHDHCInitial Entry
090177e196ae2f69\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-2021-5683-0899458
Page 263 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-18-2020 11:43:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020 11:43:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-18-2020 11:43:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-18-2020 11:43:23
(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.
Aug-18-2020 11:43:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-18-2020 11:43:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1C1SInitial Entry
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899459
Page 264 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-18-2020 11:43:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1C1SInitial Entry
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899460
Page 265 of 418
***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: 10221024 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
Aug-18-2020 11:44:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-18-2020 11:44:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-18-2020 11:44:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-18-2020 11:44:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020 11:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-18-2020 11:44:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-18-2020 11:44:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2f69\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-2021-5683-0899461
Page 266 of 418
***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: 10221024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7. Route:
Date Location User Value Reason
Aug-18-2020 11:44:21
(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
Aug-18-2020 11:44:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-18-2020 12:01:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f69\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899462
Page 267 of 418
***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: 10221024 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
Aug-18-2020 11:44:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGE
…[truncated]