Document text
Page 1 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899615
Page 2 of 397
***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: 10221053 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/24/2020
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899616
Page 3 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10221053]
2.Birth Date: 1956
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:
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899617
Page 4 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899618
Page 5 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899619
Page 6 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899620
Page 7 of 397
***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: 10221053 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:[Osteoarthrosis right lower leg]
Start Date: Nov/16/2007
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: Jul/17/2007
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Menopausal]
Start Date: Dec/4/2018
Ongoing: YES
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899621
Page 8 of 397
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [182.6]
3.Unit: LB
4.Height: [65.5]
5.Unit: in
6.Body Mass Index: [29.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899622
Page 9 of 397
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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/24/2020
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:
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899623
Page 10 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [238089]
3.Randomization Group: [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899624
Page 11 of 397
***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: 10221053 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/24/2020
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 [BPHDKP]
5.bSample ID [BPHDKR]
5.cSample ID [BP1C7C]
5.dSample ID [BP1C7D]
5.eSample ID [BP1C7F]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899625
Page 12 of 397
***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: 10221053 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/24/2020
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 [BP1C2P]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899626
Page 13 of 397
***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: 10221053 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/24/2020 11:09
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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899627
Page 14 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899628
Page 15 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899629
Page 16 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899630
Page 17 of 397
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899631
Page 18 of 397
***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: 10221053 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/14/2020
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 [BP1BMF]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899632
Page 19 of 397
***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: 10221053 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/14/2020 13:02
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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899633
Page 20 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899634
Page 21 of 397
***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: 10221053 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/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 [BP1BXH]
5.bSample ID [BPHF1R]
5.cSample ID [BPHF1Y]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899635
Page 22 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: 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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899636
Page 23 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/4/2021
2.Date of First Symptom Started: Jan/3/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/10/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
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? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
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? NO
4.iSymptoms: VOMITING
Was symptom present? YES
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899637
Page 24 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptoms - Other
5.aSymptoms - Other Text: [Fatigue]
5.bSymptoms - Other Text: [Nausea]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899638
Page 25 of 397
***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: 10221053 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.Jan/4/2021
SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899639
Page 26 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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: Jan/4/2021
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: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [Sofia 2 SARS CoV-2 Antigen FIA POC-CLIA-certified]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899640
Page 27 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: 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: 10221053 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:
Jan/4/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV10058]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899641
Page 28 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: 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: 10221053 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:[COVID test and self swab collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899642
Page 29 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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: NO
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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899643
Page 30 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899644
Page 31 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899645
Page 32 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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:
[COVID-19]
Date of Diagnosis:
Jan/4/2021
3.Toxicity Grade: 2
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899646
Page 33 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899647
Page 34 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899648
Page 35 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899649
Page 36 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899650
Page 37 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899651
Page 38 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899652
Page 39 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899653
Page 40 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899654
Page 41 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899655
Page 42 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899656
Page 43 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899657
Page 44 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899658
Page 45 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899659
Page 46 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899660
Page 47 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899661
Page 48 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899662
Page 49 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899663
Page 50 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899664
Page 51 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899665
Page 52 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899666
Page 53 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899667
Page 54 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899668
Page 55 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899669
Page 56 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899670
Page 57 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/01/2021Form: 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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899671
Page 58 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/01/2021Form: 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: 10221053 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:
Feb/1/2021
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 [BS7DVB]
5.bSample ID [BS7DVC]
5.cSample ID [BRDY0B]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899672
Page 59 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899673
Page 60 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899674
Page 61 of 397
***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: 10221053 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/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899675
Page 62 of 397
***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: 10221053 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: [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899676
Page 63 of 397
***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: 10221053 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:
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899677
Page 64 of 397
***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: 10221053 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 [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899678
Page 65 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 Moderate Chills Feb/1/2021 19:
00 NO
End Date Time:
Feb/3/2021 19:00
Repeating
Pages
2.ADVERSE EVE
NT 2 Moderate Headach
e Feb/1/2021 19:
00 NO
End Date Time:
Feb/3/2021 19:00
Repeating
Pages
3.ADVERSE EVE
NT 3 Generalized Myal
gias Feb/1/2021 19:
00 NO
End Date Time:
Feb/3/2021 19:00
Repeating
Pages
4.ADVERSE EVE
NT 4 Injection Site Pain Feb/1/2021 19:
00 NO
End Date Time:
Feb/4/2021 19:00
Repeating
Pages
5.ADVERSE EVE
NT 5 Moderate Diarrhea
Feb/4/2021 08:
00 NO
End Date Time:
Feb/7/2021 08:00
Repeating
Pages
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899679
Page 66 of 397
***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: 10221053 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)[Moderate Chills]
4.Start Date Time: Feb/1/2021 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/3/2021 19:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899680
Page 67 of 397
***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: 10221053 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[ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899681
Page 68 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Moderate Headache]
4.Start Date Time: Feb/1/2021 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/3/2021 19:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899682
Page 69 of 397
***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: 10221053 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[ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899683
Page 70 of 397
***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: 10221053 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)[Generalized Myalgias]
4.Start Date Time: Feb/1/2021 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/3/2021 19:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899684
Page 71 of 397
***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: 10221053 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[ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899685
Page 72 of 397
***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: 10221053 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)[Injection Site Pain]
4.Start Date Time: Feb/1/2021 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/4/2021 19:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899686
Page 73 of 397
***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: 10221053 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[ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899687
Page 74 of 397
***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: 10221053 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)[Moderate Diarrhea]
4.Start Date Time: Feb/4/2021 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/7/2021 08:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899688
Page 75 of 397
***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: 10221053 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[ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899689
Page 76 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899690
Page 77 of 397
***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: 10221053 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[ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899691
Page 78 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899692
Page 79 of 397
***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: 10221053 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: //
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899693
Page 80 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899694
Page 81 of 397
***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: 10221053 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?
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899695
Page 82 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899696
Page 83 of 397
***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: 10221053 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?
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899697
Page 84 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899698
Page 85 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899699
Page 86 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899700
Page 87 of 397
***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: 10221053 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:
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899701
Page 88 of 397
***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: 10221053 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:
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899702
Page 89 of 397
***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: 10221053 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?
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899703
Page 90 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899704
Page 91 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899705
Page 92 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899706
Page 93 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899707
Page 94 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899708
Page 95 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899709
Page 96 of 397
***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: 10221053 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: [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899710
Page 97 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899711
Page 98 of 397
***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: 10221053 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
Feb/1/2021
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899712
Page 99 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899713
Page 100 of 397
***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: 10221053 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 :Feb/1/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899714
Page 101 of 397
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899715
Page 102 of 397
***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: 10221053 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Patient lab samples were scanned into her COVID convalescent visit.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899716
Page 103 of 397
***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: 10221053 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:
Feb/1/2021
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 [BRDXYX]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899717
Page 104 of 397
***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: 10221053 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: Feb/1/2021 11:25
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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899718
Page 105 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899719
Page 106 of 397
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899720
Page 107 of 397
***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: 10221053 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:
Feb/19/2021
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 [BM94VG]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899721
Page 108 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899722
Page 109 of 397
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899723
Page 110 of 397
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899724
Page 111 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899725
Page 112 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899726
Page 113 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899727
Page 114 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899728
Page 115 of 397
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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/19/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899729
Page 116 of 397
***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: 10221053 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/16/2020
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899730
Page 117 of 397
***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: 10221053 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
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899731
Page 118 of 397
***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: 10221053 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 09:15:09 (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.
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899732
Page 119 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-24-2020 11:01:56 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899733
Page 120 of 397
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-14-2020 13:02:01 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899734
Page 121 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-04-2021 13:19:09 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899735
Page 122 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-04-2021 13:19:09 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899736
Page 123 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-04-2021 13:19:09 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899737
Page 124 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-04-2021 13:19:09 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899738
Page 125 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-04-2021 13:19:09 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899739
Page 126 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Jan-04-2021 13:19:09 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899740
Page 127 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Jan-04-2021 13:19:09 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899741
Page 128 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-04-2021 13:20:05 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899742
Page 129 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-04-2021 13:20:05 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899743
Page 130 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-04-2021 13:20:05 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899744
Page 131 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-04-2021 13:20:05 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899745
Page 132 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-04-2021 13:20:05 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899746
Page 133 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-04-2021 13:20:21 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899747
Page 134 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899748
Page 135 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899749
Page 136 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899750
Page 137 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899751
Page 138 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899752
Page 139 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899753
Page 140 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899754
Page 141 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899755
Page 142 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899756
Page 143 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899757
Page 144 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899758
Page 145 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899759
Page 146 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899760
Page 147 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899761
Page 148 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899762
Page 149 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899763
Page 150 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899764
Page 151 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899765
Page 152 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899766
Page 153 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899767
Page 154 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899768
Page 155 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899769
Page 156 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899770
Page 157 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899771
Page 158 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899772
Page 159 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899773
Page 160 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899774
Page 161 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899775
Page 162 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899776
Page 163 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899777
Page 164 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899778
Page 165 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-04-2021 13:20:21 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899779
Page 166 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-04-2021 13:20:41 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899780
Page 167 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899781
Page 168 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899782
Page 169 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899783
Page 170 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899784
Page 171 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899785
Page 172 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899786
Page 173 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899787
Page 174 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899788
Page 175 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899789
Page 176 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899790
Page 177 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899791
Page 178 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899792
Page 179 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899793
Page 180 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899794
Page 181 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899795
Page 182 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899796
Page 183 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899797
Page 184 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899798
Page 185 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899799
Page 186 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899800
Page 187 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899801
Page 188 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899802
Page 189 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899803
Page 190 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899804
Page 191 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899805
Page 192 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899806
Page 193 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899807
Page 194 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899808
Page 195 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899809
Page 196 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899810
Page 197 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899811
Page 198 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899812
Page 199 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899813
Page 200 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899814
Page 201 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899815
Page 202 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899816
Page 203 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899817
Page 204 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899818
Page 205 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899819
Page 206 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899820
Page 207 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899821
Page 208 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899822
Page 209 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899823
Page 210 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jJan-04-2021 13:20:41 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899824
Page 211 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-04-2021 13:21:01 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899825
Page 212 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-04-2021 13:21:01 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899826
Page 213 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aJan-04-2021 13:21:01 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899827
Page 214 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aJan-04-2021 13:21:01 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899828
Page 215 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aJan-04-2021 13:21:01 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899829
Page 216 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aJan-04-2021 13:21:01 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899830
Page 217 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-04-2021 13:21:17 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899831
Page 218 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-04-2021 13:21:17 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899832
Page 219 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aJan-04-2021 13:21:17 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899833
Page 220 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-04-2021 13:22:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899834
Page 221 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-04-2021 13:22:07 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899835
Page 222 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-04-2021 13:22:07 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899836
Page 223 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-04-2021 13:22:07 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899837
Page 224 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-04-2021 13:22:24 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899838
Page 225 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-04-2021 13:22:24 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899839
Page 226 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-04-2021 13:22:24 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899840
Page 227 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-04-2021 13:22:24 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899841
Page 228 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-04-2021 13:22:24 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899842
Page 229 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Jan-04-2021 13:22:24 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899843
Page 230 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Jan-04-2021 13:22:24 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899844
Page 231 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-04-2021 13:22:43 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899845
Page 232 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-04-2021 13:22:43 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899846
Page 233 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-04-2021 13:22:43 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899847
Page 234 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-04-2021 13:22:43 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899848
Page 235 of 397
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-04-2021 13:22:43 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899849
Page 236 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-01-2021 12:49:26 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899850
Page 237 of 397
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-01-2021 12:50:02 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899851
Page 238 of 397
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-19-2021 11:37:20 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899852
Page 239 of 397
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-19-2021 11:38:13 (UTC-08:00) Pacific
Time (US & Canada)Patient is discontinuing IP at this time.
Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899853
Page 240 of 397
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-19-2021 11:38:13 (UTC-08:00) Pacific Time
(US & Canada)Patient is discontinuing IP at this time.
Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899854
Page 241 of 397
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-19-2021 11:38:13 (UTC-08:00) Pacific Time
(US & Canada)Patient is discontinuing IP at this time.
Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899855
Page 242 of 397
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-19-2021 11:38:13 (UTC-08:00) Pacific Time
(US & Canada)Patient is discontinuing IP at this time.
Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899856
Page 243 of 397
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-19-2021 11:38:13 (UTC-08:00) Pacific Time
(US & Canada)Patient is discontinuing IP at this time.
Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899857
Page 244 of 397
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Feb-19-2021 11:38:13 (UTC-08:00) Pacific Time
(US & Canada)Patient is discontinuing IP at this time.
Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899858
Page 245 of 397
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Feb-19-2021 11:38:13 (UTC-08:00) Pacific Time
(US & Canada)Patient is discontinuing IP at this time.
Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899859
Page 246 of 397
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Feb-19-2021 11:38:13 (UTC-08:00) Pacific Time
(US & Canada)Patient is discontinuing IP at this time.
Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899860
Page 247 of 397
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Feb-19-2021 11:38:13 (UTC-08:00) Pacific Time
(US & Canada)Patient is discontinuing IP at this time.
Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899861
Page 248 of 397
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Feb-19-2021 11:38:13 (UTC-08:00) Pacific Time
(US & Canada)Patient is discontinuing IP at this time.
Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899862
Page 249 of 397
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
10Feb-19-2021 11:38:13 (UTC-08:00) Pacific Time
(US & Canada)Patient is discontinuing IP at this time.
Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899863
Page 250 of 397
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
11Feb-19-2021 11:38:13 (UTC-08:00) Pacific Time
(US & Canada)Patient is discontinuing IP at this time.
Not Done
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899864
Page 251 of 397
***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: 10221053 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 09:15:09 (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-01-2021 12:48:31 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 08:08:05 (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 Jan-04-2021 13:16:12 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899865
Page 252 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Approved Oct-20-2020 15:12:41 (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.
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899866
Page 253 of 397
***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: 10221053 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-24-2020 11:01:26
(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-24-2020 11:01:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899867
Page 254 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-24-2020 11:01:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/24/2020Initial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899868
Page 255 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-24-2020 11:01:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10221053Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-24-2020 11:01:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1956Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-24-2020 11:01:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-24-2020 11:01:42
(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-24-2020 11:01:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899869
Page 256 of 397
***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: 10221053 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-24-2020 11:01:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899870
Page 257 of 397
***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: 10221053 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-24-2020 11:02:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-24-2020 11:02:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-24-2020 11:02:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899871
Page 258 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-24-2020 12:13:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histo
ry Term:Osteoarthrosis rig
ht lower leg
Start Date: Nov/16/2007
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-24-2020 12:13:26
(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-24-2020 12:13:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Osteoarthrosis right lower legInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-24-2020 12:13:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/16/2007Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-24-2020 12:13:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899872
Page 259 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-24-2020 12:13:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Seasonal Aller
gies
Start Date: Jul/17/2007
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-24-2020 12:13:40
(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-24-2020 12:13:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal AllergiesInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-24-2020 12:13:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/17/2007Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-24-2020 12:13:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-24-2020 12:13:54
(UTC-08:00) Pacific TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899873
Page 260 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) Medical History Ter
m:Menopausa
l
Start Date: Dec/4/201
8
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-24-2020 12:13:54
(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-24-2020 12:13:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MenopausalInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-24-2020 12:13:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/4/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-24-2020 12:13:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899874
Page 261 of 397
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-24-2020 11:02:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-24-2020 11:02:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
182.6Initial Entry
3. Unit:
Date Location User Value Reason
Aug-24-2020 11:02:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-24-2020 11:02:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
65.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-24-2020 11:02:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-24-2020 11:02:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.9Initial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (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-2021-5683-0899875
Page 262 of 397
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a
Date Location User Value Reason
Aug-24-2020 11:02:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.2
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-24-2020 11:02:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-24-2020 11:02:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-24-2020 11:02:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-24-2020 11:02:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (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-2021-5683-0899876
Page 263 of 397
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-24-2020 11:02:57
(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-24-2020 11:02:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-24-2020 11:02:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-24-2020 11:02:57
(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-24-2020 11:02:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-24-2020 11:02:57
(UTC-08:00) Pacific TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899877
Page 264 of 397
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 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-24-2020 11:02:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-24-2020 11:02:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-24-2020 11:02:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899878
Page 265 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-24-2020 11:05:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-24-2020 11:05:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
238089Initial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899879
Page 266 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020 12:53:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020 12:53:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020 12:53:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-24-2020 12:53:22
(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-24-2020 12:53:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020 12:53:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHDKPInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899880
Page 267 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-24-2020 12:53:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHDKPInitial Entry
5.b
Date Location User Value Reason
Aug-24-2020 12:53:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHDKRInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-24-2020 12:53:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHDKRInitial Entry
5.c
Date Location User Value Reason
Aug-24-2020 12:53:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1C7CInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-24-2020 12:53:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1C7CInitial Entry
5.d
Date Location User Value Reason
Aug-24-2020 12:54:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1C7DInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (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-2021-5683-0899881
Page 268 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Aug-24-2020 12:54:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1C7DInitial Entry
5.e
Date Location User Value Reason
Aug-24-2020 12:54:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1C7FInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-24-2020 12:54:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1C7FInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899882
Page 269 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020 11:03:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020 11:03:25
(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-24-2020 11:03:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-24-2020 11:03:25
(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-24-2020 11:03:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020 11:03:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1C2PInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899883
Page 270 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-24-2020 11:03:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1C2PInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899884
Page 271 of 397
***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: 10221053 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-24-2020 11:15:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-24-2020 11:15:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-24-2020 11:15:59
(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-24-2020 11:15:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020 11:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-24-2020 11:15:59
(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-24-2020 11:15:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899885
Page 272 of 397
***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: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7. Route:
Date Location User Value Reason
Aug-24-2020 11:15:59
(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-24-2020 11:15:59
(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-24-2020 12:12:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899886
Page 273 of 397
***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: 10221053 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-24-2020 11:04:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899887
Page 274 of 397
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-14-2020 13:01:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899888
Page 275 of 397
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-14-2020 13:01:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
2.a
Date Location User Value Reason
Sep-14-2020 13:01:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.6
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-14-2020 13:01:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-14-2020 13:01:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-14-2020 13:01:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (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-2021-5683-0899889
Page 276 of 397
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-14-2020 13:01:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899890
Page 277 of 397
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
3. Collection Date:
Date Location User Value Reason
Sep-14-2020 13:02:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Sep-14-2020 13:01:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-14-2020 13:01:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-14-2020 13:01:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-14-2020 13:01:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae2f6a\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899891
Page 278 of 397
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1022 Site Name: (1022) Wenatchee Valley Hospital Clinics
Subject No: 10221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-14-2020 13:03:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-14-2020 13:03:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020 13:04:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-14-2020 13:03:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes,
…[truncated]